stroke

Are Calcium Supplements Safe?

by

What Does This Study Mean For You?

Author: Dr. Stephen Chaney 

Pendulum
Pendulum

Should you avoid calcium supplements because they increase your risk of heart disease? Some headlines and blog posts would have you believe that. You may have been told that by your doctor. But is it true?

Unfortunately, this is another example of the swinging pendulum that we often see in supplement studies. One day a study comes out saying that calcium supplements increase the risk of heart disease. A few months later another study comes out saying that is not true. Calcium supplements don’t increase heart disease risk.

The pendulum keeps swinging until you are totally confused. You don’t know what to believe. And “experts” (including your doctor) pick one side or the other depending on what they believe about supplements in general.

I have told you before that good scientists wait until multiple studies have been done and base their opinion based on what the preponderance of studies show. I can tell you that multiple studies have been done and the preponderance of studies show that calcium supplements do not increase the risk of heart disease. But that doesn’t prove that calcium supplements are safe. It just shows they are likely to be safe.

That is why the authors of the current study (X Huo et al, Current Developments In Nutrition, volume 7, Issue 3: 100046, March 2023) analyzed the weaknesses of previous studies and tried to design a study that lacked those weaknesses.

How Was This Study Done?

clinical studyThe investigators searched through the literature to identify all placebo-controlled, randomized clinical trials (the gold standard for clinical studies) assessing the effects of calcium supplements alone or calcium supplements with vitamin D on heart disease, stroke, and all-cause mortality.

They restricted their analysis to studies with at least 500 participants that lasted for at least a year. They further restricted their analysis to studies whose authors were willing to share unpublished data on the number of participants in each treatment group who had a heart attack, stroke, or any other kind of heart disease; died from heart disease; or died from all causes during the study.

They ended up with 11 clinical studies in their analysis. The breakdown was as follows:

  • Seven studies with 8,634 participants compared calcium alone with placebo.
    • Participants in these studies averaged 71 years old and were 79% female.
    • The daily calcium dose varied from 1.0 to 1.5 g/day.
    • The mean duration of treatment was 4.1 years (range = 2-5 years).
  • Six studies with 46,804 participants compared calcium plus vitamin D with placebo.
    • Participants in these studies averaged 65 years old and were 98% female.
    • The daily calcium dose varied from 1.0 to 1.5 g/day and the daily vitamin D dose ranged from 400 to 2,000 IU/d.
    • The mean duration of treatment was 6 years (range = 1.5-7 years).
  • In case you were wondering about the math, some studies included both calcium alone versus placebo and calcium plus vitamin D versus placebo.

The authors then combined the data from all 11 studies and performed a meta-analysis on the effect of calcium alone on adverse heart outcomes and calcium plus vitamin D on adverse heart outcomes.

Are Calcium Supplements Safe? 

calcium supplementsThe results were clear-cut.

  • Calcium alone was not significantly associated with any increased risk of heart attack, stroke, heart disease of any kind, deaths from heart disease, and deaths from all causes.
  • Calcium with vitamin D was not significantly associated with any excess risk of heart attack, stroke, heart disease, deaths from heart disease, and deaths from all causes.

In their discussion, the authors pointed out two caveats to their conclusions:

  • In the calcium only portion of the meta-analysis the number of participants who experienced a stroke or types of heart disease other than heart attack and stroke was very small. So, they could not exclude an absolute increased risk of 0.3-0.5% per year for these types of rare events.
  • The participants in the 11 studies included in their meta-analysis were not selected based on their risk of heart disease. So, the authors could not exclude the possibility that calcium supplements might increase the risk of heart disease in people who were already at high risk of heart disease.

The authors concluded, “This meta-analysis demonstrated that calcium supplements were not associated with any significant hazard for heart disease, stroke, or all-cause mortality…Hence, for people with low bone density and low absolute risks of heart disease, the present report demonstrates no concern about excess heart disease risks associated with calcium supplements.

However, further large trials are needed to assess the efficacy and safety of combined supplementation with calcium and vitamin D for the prevention of osteoporotic fracture in older people at high risk of heart disease.”

What Does This Study Mean For You?

Questioning WomanAs I said above, the preponderance of evidence suggests that calcium supplementation does not increase your risk of heart disease. This study reinforces that conclusion.

I can’t guarantee that some future study won’t come to the opposite conclusion, and the pendulum will swing again. And I can’t guarantee that your doctor has kept up with the most recent literature on calcium supplementation and heart disease risk.

The authors of this study also pointed out that we don’t have any clinical studies on the effect of calcium on heart disease risk if you are already at high risk of heart disease. So, if you are at high risk of heart disease, any advice that I or your doctor give you about calcium supplementation might be wrong. We simply don’t know.

Finally, I realize that you may be equally confused about whether calcium supplementation can strengthen your bones and reduce your risk of osteoporosis. I won’t discuss that question today. Instead, I will refer you to two previous articles I have written in “Health Tips From the Professor” on that topic.

The first article discusses the flaws in previous studies claiming that calcium supplements are ineffective at increasing bone density and preventing osteoporotic fracture.

The second article describes a bone-healthy lifestyle.

The Bottom Line

While the preponderance of studies have shown that calcium supplementation does not increase the risk of heart disease, that conclusion remains controversial.

To clarify that issue, a group of investigators searched through the literature to identify all placebo-controlled, randomized clinical trials (the gold standard for clinical studies) assessing the effects of calcium supplements alone or calcium supplements with vitamin D on heart disease, stroke, and all-cause mortality. They then performed a meta-analysis of those clinical studies.

Their meta-analysis showed that:

  • Calcium alone was not significantly associated with any increased risk of heart attack, stroke, heart disease of any kind, deaths from heart disease, and deaths from all causes.
  • Calcium with vitamin D was not significantly associated with any excess risk of heart attack, stroke, heart disease, deaths from heart disease, and deaths from all causes.

This study strengthens the conclusion that calcium supplementation does not increase the risk of heart disease.

For more details about the study and references discussing the effect of calcium supplementation on bone density, read the article above.

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure, or prevent any disease.

______________________________________________________________________________

My posts and “Health Tips From the Professor” articles carefully avoid claims about any brand of supplement or manufacturer of supplements. However, I am often asked by representatives of supplement companies if they can share them with their customers.

My answer is, “Yes, as long as you share only the article without any additions or alterations. In particular, you should avoid adding any mention of your company or your company’s products. If you were to do that, you could be making what the FTC and FDA consider a “misleading health claim” that could result in legal action against you and the company you represent.

For more detail about FTC regulations for health claims, see this link.

https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance

_______________________________________________________________________

About The Author

Dr. Chaney has a BS in Chemistry from Duke University and a PhD in Biochemistry from UCLA. He is Professor Emeritus from the University of North Carolina where he taught biochemistry and nutrition to medical and dental students for 40 years.  Dr. Chaney won numerous teaching awards at UNC, including the Academy of Educators “Excellence in Teaching Lifetime Achievement Award”. Dr Chaney also ran an active cancer research program at UNC and published over 100 scientific articles and reviews in peer-reviewed scientific journals. In addition, he authored two chapters on nutrition in one of the leading biochemistry text books for medical students.

Since retiring from the University of North Carolina, he has been writing a weekly health blog called “Health Tips From the Professor”. He has also written two best-selling books, “Slaying the Food Myths” and “Slaying the Supplement Myths”. And most recently he has created an online lifestyle change course, “Create Your Personal Health Zone”. For more information visit https://chaneyhealth.com.

For the past 45 years Dr. Chaney and his wife Suzanne have been helping people improve their health holistically through a combination of good diet, exercise, weight control and appropriate supplementation.

Omega-3 Supplements Are Safe

by

Why Do Clinical Studies Disagree? 

Author: Dr. Stephen Chaney 

Pendulum
Pendulum

Six weeks ago, the title of my “Health Tips From the Professor” article was, “Are Omega-3 Supplements Safe?” That’s because I was reviewing a study that claimed long-term use of omega-3 supplements increased the risk of atrial fibrillation and stroke. And it had led to headlines like, “Omega-3 Supplements May Increase the Risk of Heart Disease” and “Fish Oil Supplements May Increase The Risk of Stroke and Heart Conditions”.

This week, the title of my article is, “Omega-3 Supplements Are Safe”. I did not choose this title to express my opinion, although I am in general agreement with the statement. I chose that title because the omega-3 pendulum has swung again. The article (M Javaid et al, Journal of The American Heart Association, Volume 13, Number 10: e032390, 2024) I am reviewing today came to the conclusion that omega-3 supplements don’t increase the risk of stroke.

I understand your confusion. You are wondering how scientists can tell you one thing today and the total opposite tomorrow. It is conflicting results like this that cause the public to lose faith in science. And when people lose faith in science they are easily influenced by “snake oil” charlatans on the internet.

So, after I describe this study, I will discuss why scientific studies come up with conflicting results and compare these two studies in detail. That is probably the most important part of this article.

How Was This Study Done?

clinical studyScientists from Freeman Hospital and Newcastle University in the UK conducted a meta-analysis combining the data from 120,643 patients enrolled in 11 clinical trials that evaluated the effects of omega-3 supplementation. The inclusion criteria for this meta-analysis were as follows:

  • The studies were randomized trials that compared omega-3 supplements with placebo or standard treatment. Half the patients received the omega-3 supplement.
  • The patients were either previously diagnosed with heart disease or were at high risk of developing heart disease.
  • The studies reported the incidence of bleeding events.

The study asked whether omega-3 supplementation increased the risk of bleeding events (defined as hemorrhagic stroke, intracranial bleeding, or gastrointestinal bleeding) compared to a placebo or standard treatment.

Omega-3 Supplements Are Safe

Omega-3s And Heart DiseaseThe results were reassuring for omega-3 supplement users. When compared to a placebo or standard treatment, omega-3 supplements.

  • Did not increase the risk of overall bleeding events.
  • Did not increase the risk of hemorrhagic stroke, intracranial bleeding, or gastrointestinal bleeding.
  • Did not increase the risk of bleeding in patients who were also taking blood thinners (Blood thinners reduce the ability of blood to clot and can lead to bleeding events. This study found that adding omega-3 supplements to these drugs did not increase bleeding risk.

But here is where it gets interesting. One of the 11 studies included in the meta-analysis used a high dose (4 grams/day) of Vascepa, a highly purified ethyl ester of EPA produced by the pharmaceutical company Amarin. When the authors analyzed the data from this study alone, they found that Vascepa:

  • Increased the relative risk of bleeding by 50% compared to the control group.
    • While this sounds scary, the absolute risk of bleeding was only increased by 0.6% compared to the control group.
    • I will explain the difference between relative risk and absolute risk below. But for now, you can think of absolute risk as a much more accurate estimate of your actual risk.

The authors of the meta-analysis speculated that the increased bleeding risk associated with the use of Vascepa could be due to the:

  • High dose of EPA (4 gm/day) or…
  • Lack of DHA and other naturally occurring omega-3s in the formulation. The authors said:
    • The effect of DHA on the endothelial lining is weaker than that of EPA (EPA makes the endothelial lining “less sticky” which reduces its ability to trigger blood clot formation. This is one of the mechanisms by which EPA is thought to decrease blood clot formation.)
    • The ability of DHA to inhibit oxidation of Apo-B-containing particles was less sustained than that of EPA (Oxidized Apo-B-containing particles increase the risk of blood clot formation. Inhibition of that oxidation by EPA is another of the mechanisms by which EPA is thought to decrease blood clot formation.)

The authors concluded, “Omega-3 PUFAs [polyunsaturated fatty acids] were not associated with increased bleeding risk. Patients receiving high-dose purified EPA [Vascepa] may incur additional bleeding risk, although its clinical significance is very modest.”

What Is The Difference Between Relative And Absolute Risk?

Question MarkRelative risk is best defined as the percentage increase or decrease in risk compared to the risk found in a control group. Absolute risk, on the other hand, is the actual increase or decrease in risk in the group receiving the intervention.

Relative risk is an excellent tool for identifying risks. However, it magnifies the extent of the risk, so it can be misleading. For example,

  • If the absolute risk of some event occurring in the general population was 40%, a 50% increase in relative risk would increase the absolute risk by 20% (40% X 0.5 = 20%) to give a total risk of 60% (40% + 20%). In this case, both the relative and absolute risk are significantly large numbers.
  • However, if the absolute risk in the general population was 1%, a 50% increase in relative risk would only increase the absolute risk to 1.5%, a 0.5% increase in absolute risk. In this case, the increase in relative risk appears significant, but it is misleading because the absolute increase in risk is a modest 0.5%.
  • The latter resembles the situation in this study when the authors compared bleeding events in patients receiving Vascepa to those receiving a placebo. The absolute risk of bleeding events in the control group was 1.2%. The risk of bleeding events in the Vascepa group was 1.8%. That is a 50% increase in relative risk but only a 0.6% increase in absolute risk.

Why Do Clinical Studies Disagree?

Confusion Clinical StudiesAs I have said many times before, there is no perfect clinical study. Every study has its strengths and its flaws. So, it is perhaps instructive to compare this study and the previous study I reviewed 6 weeks ago. Here are some of the questions I ask when evaluating the strengths and weaknesses of clinical studies.

#1: What kind of study is it?

  • The previous study was an association study. It can only report on associations. It cannot determine cause and effect. Outcomes like atrial fibrillation and strokes could have been caused by unrelated variables in the population studied.
  • The current study was a meta-analysis of 11 randomized controlled clinical trials. Because the only difference between the two groups is that one received omega-3 supplements, it can determine cause and effect.

#2: How many people were in the study?

  • Both studies were very large, so this was not a factor.

#3: How long was the study?

  • The previous study lasted 12 years. The clinical trials within this meta-analysis lasted one to five years. This is a slight advantage for the previous study because it might be better able to detect risks of chronic use of omega-3 supplements.

#4: How were participants selected?

  • Participants in the previous study had no previous diagnosis of heart disease while participants in the current study either had a previous diagnosis of heart disease or were at high risk of developing heart disease.

This difference would be relevant if both studies were looking at the benefits of omega-3 supplements. However, the current study was only looking at the side effects of omega-3 supplements, so this is not an important consideration.

Doctor With Patient#5: How was omega-3 intake monitored?

  • This was a significant flaw of the previous study. Use of omega-3 supplements was determined by a questionnaire administered when the subjects entered the study. No effort was made to determine whether the amount of omega-3s consumed remained constant during the 12-year study.
  • The clinical studies within the current meta-analysis were comparing intake of omega-3 supplements to placebo and monitored the use of the omega-3 supplements throughout the study.

#6: What is the dose-response?

  • This was another serious flaw of the previous study. There was no dose-response data.
  • The current study provided limited dose-response data. From the data they presented it appeared that the risk of bleeding events was only slightly dose-dependent except for the clinical study with the high dose (4 gm/day) EPA-only Vascepa drug. It was a clear outlier, which is why they analyzed the data from that study independently from the other studies.

#7: What outcomes were measured?

  • The only common outcome measured in the two studies was hemorrhagic stroke.
  • The previous study reported that omega-3 supplementation increased the risk of stroke by 5% in the general population. However:
    • That result just barely reached statistical significance.
    • It was a 5% increase in relative risk. The authors did not report absolute risk.
    • It was an association study, so it could not determine cause and effect.
  • The current study found omega-3 supplementation had no effect on the risk of stroke in a population that either had heart disease or were at high risk of heart disease.
    • The exception, of course, was the group taking the high dose Vascepa drug (see below).

Heart Disease Study#8: Was the risk clinically significant?

  • As I said above, the previous study only reported relative risk, which can be misleading. However, absolute risk can be calculated from their data. For example,
    • The risk of developing atrial fibrillation in the group taking omega-3 supplements was 4.4% (calculated from Table 2 of the manuscript). The authors said that represented a 13% increase in relative risk compared to the group not taking omega-3 supplements. This means the absolute (actual) increase in risk is about 0.6%.
    • The risk of stroke in the group taking omega-3 supplements was 1.5% (calculated from Table 2 of the manuscript). The authors said that represented a 5% increase in relative risk compared to the group not taking omega-3 supplements. This means the absolute (actual) increase in risk is about 0.08%.
  • In the current study the increased risk of stroke in the group taking the high-dose (4 gm/day) EPA-only Vascepa drug was 50% for relative risk, but only 0.6% for absolute risk.
    • The authors of the current study argued that, based on absolute risk, the risk of stroke for people taking Vascepa was “clinically insignificant”. I would argue the same is true for the results reported in the previous study and the headlines they generated.

#9: Who sponsored the study? 

  • The previous study was supported by the Bill and Melinda Gates Foundation, an organization that has no obvious interest in the outcome of the study.
  • The current study is sponsored by Amarin, the pharmaceutical company that manufactures and markets Vascepa.
    • However, to their credit, the authors made no effort to hide the negative data about Vascepa.
      • In fact, they highlighted the negative data, noted that the increased bleeding risk with Vascepa was different from the omega-3 supplements studied, and offered possible explanations for why a high potency, EPA-only supplement might increase the risk of bleeding more than a lower potency omega-3 supplement containing both EPA and DHA.
    • They did, however, choose to emphasize the 0.6% absolute increase in bleeding risk rather than the 50% relative increase in bleeding risk. However, as I noted above absolute risk is a more accurate way to report risk, especially when the risk in the control group is only 1.2%.

Perspective On This Comparison:

You may be tempted to conclude that the previous study was garbage. Before you do, let me provide some perspective.

  • The data for that study came from the UK Biobank, which is a long-term collection of data by the British government from over 500,000 residents in the United Kingdom. The data are made available to any researcher who wants to study links between genetic and environmental exposure to the development of disease. However, the data were not collected with any particular study in mind.

This is why omega-3 intake was only determined at the beginning of the study and there was no dose-response information included. The experimental design would have been different if the study were specifically designed to measure the influence of omega-3 supplementation on health outcomes. However, because of cost, the sample size would have been much smaller, which would have made it difficult to show any statistically significant results.

  • Relative risk rather than absolute risk is almost universally used to describe the results of clinical studies because it is a larger number and draws more attention. However, as I described above, relative risk can be misleading. In my opinion, both relative and absolute risk should be listed in every publication.

What Does This Study Mean For You?

ConfusionScientists know that every study has their flaws, so we don’t base our recommendations on one or two studies. Instead, we look at the totality of data before making recommendations. When looking at the totality of data two things stand out.

  • The bleeding risk with Vascepa is not unique. There are some studies suggesting that high dose (3-4 gm/day) omega-3 supplements containing both EPA and DHA may increase bleeding risk, although probably not to the same extent as Vascepa.
  • An optimal Omega-3 Index of 8% is associated with a decreased risk of heart disease and does not appear to increase the risk of atrial fibrillation or bleeding events such as hemorrhagic stroke. And for most people, an 8% Omega-3 Index can be achieved with only 1-2 gm/day of omega-3s.

So, my recommendations are the same as they were 6 weeks ago.

  • Be aware that high-dose (3-4 gm/day) of omega-3 supplements may cause an increased risk of atrial fibrillation and stroke, but the risk is extremely small.
  • Omega-3 supplementation in the 1-2 gm/day range appears to be both safe and effective.
  • I recommend getting your Omega-3 Index determined, and if it is low, increasing your omega-3 intake to get it into the 8% range.

The Bottom Line

A recent meta-analysis concluded that omega-3 supplementation does not increase the risk of bleeding events, including hemorrhagic stroke, intracranial bleeding, and gastrointestinal bleeding.

The exception was the high-dose (4 gm/day), EPA-only drug Vascepa, which increases bleeding risk from 1.2% to 1.8%, a 0.6% increase in absolute risk.

This study contradicts a previous study I shared with you only six weeks ago, so I made a detailed comparison of the strengths and weaknesses of each study.

For more details on these studies and what they mean for you, read the article above.

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure or prevent any disease.

_____________________________________________________________________________

My posts and “Health Tips From the Professor” articles carefully avoid claims about any brand of supplement or manufacturer of supplements. However, I am often asked by representatives of supplement companies if they can share them with their customers.

My answer is, “Yes, as long as you share only the article without any additions or alterations. In particular, you should avoid adding any mention of your company or your company’s products. If you were to do that, you could be making what the FTC and FDA consider a “misleading health claim” that could result in legal action against you and the company you represent.

For more detail about FTC regulations for health claims, see this link.

https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance

_______________________________________________________________________

About The Author 

Dr. Chaney has a BS in Chemistry from Duke University and a PhD in Biochemistry from UCLA. He is Professor Emeritus from the University of North Carolina where he taught biochemistry and nutrition to medical and dental students for 40 years.

Dr. Chaney won numerous teaching awards at UNC, including the Academy of Educators “Excellence in Teaching Lifetime Achievement Award”.

Dr Chaney also ran an active cancer research program at UNC and published over 100 scientific articles and reviews in peer-reviewed scientific journals. In addition, he authored two chapters on nutrition in one of the leading biochemistry text books for medical students.

Since retiring from the University of North Carolina, he has been writing a weekly health blog called “Health Tips From the Professor”. He has also written two best-selling books, “Slaying the Food Myths” and “Slaying the Supplement Myths”. And most recently he has created an online lifestyle change course, “Create Your Personal Health Zone”. For more information visit https://chaneyhealth.com.

For the past 45 years Dr. Chaney and his wife Suzanne have been helping people improve their health holistically through a combination of good diet, exercise, weight control and appropriate supplementation.

Are Omega-3 Supplements Safe?

by

The Flaws And Blind Spots In This Study

Author: Dr. Stephen Chaney

Pendulum
Pendulum

Has the omega-3 pendulum swung again? The recent headlines are downright scary. For example:

  • “Fish Oil May Increase the Risk of Stroke and Heart Conditions.”
  • “Fish Oil Supplements May Cause Harm, Study Finds. Is It Time to Ditch Them?”
  • “Fish Oil Supplements May Lead to Heart Problems”.
  • “Regular Use of Fish Oil Supplements Might Increase, Rather Than Lessen, The Risk of First Time Heart Disease and Stroke Among Those in Good Cardiovascular Health.”

Yikes! That sounds bad. Should we be thinking about giving up our omega-3 supplements?

But wait. Just a few weeks earlier we were reading headlines about the benefits and lack of side effects from omega-3 supplements. That’s confusing. Which headlines are correct?

To answer these questions:

  • I will point out the flaws and blind spots in the study.
  • I will strip away the hyperbole and put the headlines into perspective.

How Was The Study Done?

clinical studyThe investigators made use of data from the UK Biobank Study. The UK Biobank Study is a large, long-term study in the United Kingdom which was designed to investigate the contributions of genetic predisposition and environmental exposure [including diet and supplementation] to the development of disease.

The UK Biobank Study enrolled 502,461 participants, aged 40-69 years, between January 1st, 2006 and December 31st, 2010. Participants were followed from entry into the program until March 31st 2021, an average of 11.9 years.

The current study excluded any participants who had a diagnosis of atrial fibrillation, heart failure, heart attack, stroke, or cancer at entry into the study, leaving 415,737 participants.

The participants were:

  • 55% women.
  • Average age of 56 years, with 83.4% of them below 65 years old at entry into the study.
  • 94.5% white.

The study was designed in a unique manner, in that it was designed to test the effect of omega-3 supplements on 6 specific transitions:

  • Primary prevention. This measured the transition of healthy (no diagnosed heart disease) people to either atrial fibrillation, major cardiovascular events, or death.
  • Secondary prevention. This measured the transition from atrial fibrillation to either major cardiovascular events or death.
  • Tertiary prevention. This measured the transition from major cardiovascular events to death.
  • Major cardiovascular events were further broken down to heart attacks, stroke and heart failure.

Participants were asked whether they used fish oil supplements when they entered the study and were categorized as either regular users or non-users. [Note: The users were not asked the dose or brand of fish oil supplements they used.]

Deaths were obtained from the national death registry and disease diagnosis from the National Health Service.

Are Omega-3 Supplements Safe?

omega-3 fish oil supplementHere is what the study found.

Primary Prevention – For healthy individuals (defined as having no diagnosed heart disease) using omega-3 supplements for an average of 11.9 years:

  • Increased the risk of atrial fibrillation by 13%.
  • Did not affect the risk of major cardiovascular events and death were unaffected by omega-3 supplementation.
  • When major cardiovascular events were broken down to their component parts, omega-3 supplementation:
    • Decreased the risk of heart failure by 8%.
    • Increased the risk of stroke by 5% (this was just barely statistically significance).
    • Did not affect the risk of heart attack.

Secondary Prevention – For individuals with atrial fibrillation omega-3 supplementation:

  • Decreased the risk of major cardiovascular events by 9%.
  • Decreased the risk of death by 8%.
  • When major cardiovascular events were broken down into their component parts, omega-3 supplementation:
  • Decreased the risk of heart attacks by 15%.
  • Had no effect on the risk of stroke or heart failure.

Tertiary Prevention – For people who suffered major cardiovascular events during the study omega-3 thumbs upsupplementation:

  • Decreased the risk of death by 8%.

Since this is a very complex set of data, I have coded positive results in green and negative results in red.

And as if these complexities were not enough, when the investigators broke these effects down by population groups:

  • Omega-3 supplementation decreased the transition from healthy to death for men (7% decrease) and participants older than 65 (9% decrease).

I will discuss the significance of these observations below.

The authors concluded, “Regular use of fish oil supplements might be a risk factor for atrial fibrillation and stroke among the general population but could be beneficial for [reducing] progression of cardiovascular disease from atrial fibrillation to major adverse cardiovascular events, and from atrial fibrillation to death.”

In short, they were suggesting that omega-3 supplements should be avoided by the general population because they have no positive benefits and might increase the risk of atrial fibrillation and stroke. But omega-3 supplements may be useful for those who already have heart disease.

Some of the articles you may have read about the study repeated this message. Others just emphasized the negative aspects of the study.

But is this message accurate? Let me start by discussing the flaws, blind spots, and hidden data in this study. Then I will summarize the 3 key findings of the study and tell you what they mean for you.

The Flaws, Blind Spots, And Hidden Data In This Study

flawsFlaws: As I said above, there were two major flaws in the study.

Flaw #1: The study did not identify the dose of supplement used. This is important because the increased risk of atrial fibrillation and stroke is primarily seen in clinical trials using high dose omega-3 supplements.

Flaw #2: This was an association study which cannot prove cause and effect. However, the authors of this study reported it as showing that omega-3 supplement use caused atrial fibrillation and stroke – and all the news reports on the study have repeated that claim.

Flaw #3: Other experts have pointed out that the authors inflated the risks associated with omega-3 supplementation by reporting relative risk rather than absolute risk. Let me try to simplify the distinction.

The risk of atrial fibrillation was 4.24% in the non-supplement users and 4.80% in the omega-3 supplement users. That is an absolute increase in risk of 0.56% (4.80% – 4.24%). This is the increase in risk you actually experience. In contrast, 4.80% is 13% greater than 4.24%, which is how relative risk is calculated.

In response to the questions you are probably thinking:

  • Yes, this is a perfect example of the Mark Twain quote, “There are lies. There are damn lies. And then there are statistics.”
  • Yes, all the percentages reported in this study are based on relative risk and are, therefore, inflated. However, I do not have access to their data, so I cannot tell you the absolute risk associated with their other observations.

Blind Spots: In their paper the investigators recommended against the use of omega-3 supplements to prevent heart disease because their data showed:

  • No benefit of omega-3 supplementation for preventing major cardiovascular events and deaths in a healthy population.
  • But did suggest an increased risk of atrial fibrillation and stroke in that same population.

However, their blind spot was in underestimating the difficulty of showing the benefit of any intervention in a healthy population. The example I always use is statin drugs. Statin Drugs:

  • Dramatically reduce the risk of a second heart attack and/or death in people who have already had a heart attack.
  • Reduce the risk of heart attacks in people who are at high risk of heart attacks.
  • Cannot be shown to reduce the risk of heart attacks in a healthy population.

This study suggests that omega-3 supplements are no different. In this study, omega-3 supplements:

  • Reduced the risk of death in people who had already experienced a major cardiovascular event like a heart attack or stroke.
  • Reduced the risk of major cardiovascular events and death in people with atrial fibrillation, which puts them at high risk for a heart attack or stroke.
  • Could not be shown to reduce the risk of major cardiovascular events or deaths in a healthy population.

Hidden Data: There are some important data that were buried in the text and supplemental figures but were Skepticignored in the concluding remarks of this study and all the articles written about it. For example:

  • The original study and all articles written about the study reported that omega-3 supplementation increased the risk of stroke in otherwise healthy individuals but ignored the observation that omega-3 supplementation decreased the risk of heart failure in that same group.

The second example of hidden data likely represents another blind spot of the authors. They concluded that omega-3 supplementation had no benefit for healthy individuals without asking whether omega-3 supplements might benefit higher-risk subpopulations within this group. To help you understand this statement let me start by giving you some perspective.

As I said above, statin drugs cannot be shown to reduce the risk of heart attacks in a healthy population. But when you include people at high risk of heart disease with healthy people in the dataset, you start to see a reduced risk of heart attacks.

Similarly, with supplements you often see no benefits with the general population, which is what is usually reported in the media. But when you look at higher risk groups within that population, the benefits of supplementation emerge.

This study is no different:

  • For healthy individuals, omega-3 supplementation had no effect on deaths during the 12-year follow-up period.
  • However, omega-3 supplementation reduced the risk of death by 9% for both men and people ≥ 65. These represent two groups with elevated risk of heart disease within the otherwise healthy population.
  • Once again, these data were completely ignored.

What Does This Study Mean For You?

This study made 3 major points:

Point #1: Let me start with the one you’ve heard the most about. The risk of atrial fibrillation and stroke associated with omega-3 supplementation is real. We should not ignore it.

But what this study and most of the reports on the study didn’t tell you is that the risk is dose dependent. The risk is primarily seen with high doses of omega-3s. While no one has done a comprehensive dose response analysis, I can tell you that these side effects are:

  • Seldom reported in clinical studies at doses of 1 gm/day or less.
  • Sometimes reported in clinical studies at doses of ≥2 gm/day.
  • Frequently reported in clinical studies at doses of ≥4 gm/day.

However, atrial fibrillation and stroke occur in a very small percentage of omega-3 users, even at 4 gm/day. At this point we have no idea why some people are susceptible to these side effects and others are not. More research in this area is clearly needed.

Until we know more about who is at risk, my recommendation for people who are trying to reduce the risk of heart disease is to rely on something called the Omega-3 Index to determine your individual omega-3 needs rather than using high-dose omega-3 supplements.

  • The Omega-3 Index measures the amount of omega-3 fatty acids in your tissues. It is determined by the amount of omega-3s you consume and how you metabolize them, so it is individualized to you.
  • An Omega-3 Index of 4% is associated with a high risk of heart disease, while an Omega-3 Index of 8% is associated with a low risk of heart disease. There is no evidence that more than 8% provides additional benefit.
  • Most importantly, it only takes 1-1.6 gm/day of omega-3s to raise your Omega-3 Index from 4% to 8%. At these doses your risk of atrial fibrillation and stroke is extremely small.

For example, a recent meta-analysis of 29 studies with a total of 183,292 participants reported that people with an 8% Omega-3 Index had:

  • Decreased risk of ischemic stroke (stroke due to blood clots) with no detectable increased risk of hemorrhagic stroke (stroke due to bleeding), and…
  • No detectable increased risk of atrial fibrillation.

I recommend getting your Omega-3 Index determined, and if it is low, increasing your omega-3 intake to get it into the 8% range. Some people go from 4% to 8% more rapidly than others, so you may need to repeat the test several times to optimize your Omega-3 Index.

If your health professional doesn’t have access to the Omega-3 Index test, you can order it from https://omegaquant.com (I have no financial stake in this company, but I know it as a reputable source of the Omega-3 Index test).

Does The Professor Plan To Reduce His Intake Of Omega-3 Fatty Acids? Three weeks ago, I shared thatprofessor owl my wife and I have been taking around 3 gm/day of omega-3 supplements for the past 40 years. Now that the association of atrial fibrillation and stroke with high dose omega-3 intake has been firmly established, some of you may be wondering whether we plan to decrease our intake of omega-3 supplements.

The answer is, “No”. Remember that the increased risk of atrial fibrillation and stroke is only seen for a small subset of people taking high-dose omega-3 supplements. If we were part of that subset, we would likely have experienced one of those side effects by now.

However, if you are considering omega-3 supplementation for the first time, you don’t know whether you are part of that subset or not. So, my advice remains the same. Rely on optimizing your Omega-3 Index rather than high-dose omega-3 supplementation.

Point #2: Healthy individuals (those with no symptoms of heart disease) do not benefit from omega-3 supplementation. As I pointed out above, this ignores data from their study, namely.

  • Omega-3 supplementation reduced the risk of heart failure in healthy subjects.
  • Omega-3 supplementation reduced the risk of death in higher risk groups within the healthy population (namely men and people 65 and older).

Confusion Clinical StudiesAs I discussed above, this is a pattern seen with statin drugs and most nutritional supplements. Simply put, you can’t show any benefit of statin drugs or most nutritional supplements in a “healthy” population, but you can show benefit when you focus on higher risk individuals within the “healthy” population.

The problem, of course, is that most of us don’t really know whether we are “healthy” or not. For millions of Americans the first indication that they are at risk from heart disease is sudden death from a heart attack or stroke.

With that in mind, I will leave the decision about whether you want to supplement with omega-3s up to you. But if you decide to supplement, I recommend you optimize your Omega-3 Index rather than using a high dose omega-3 supplement.

Point #3: People with heart disease benefit from omega-3 supplementation. This recommendation is becoming non-controversial, so I won’t comment further other than to say high dose omega-3 supplements are probably not needed unless prescribed by your health professional.

The Bottom Line

You have been asking me about recent headlines saying that omega-3 supplements may increase rather than decrease the risk of heart disease. So, I analyzed the study behind the headlines. The study makes 3 claims:

  • Omega-3 supplements increase the risk of atrial fibrillation and stroke when taken by healthy people.
  • Omega-3 supplements are of no benefit for healthy individuals.
  • Omega-3 supplements are beneficial for people who have heart disease.

In the article above I review the flaws, blind spots, and hidden data in the article and discuss what it means for you.

For more details about this study and what it means for you read the article above.

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure, or prevent any disease.

 ______________________________________________________________________________

My posts and “Health Tips From the Professor” articles carefully avoid claims about any brand of supplement or manufacturer of supplements. However, I am often asked by representatives of supplement companies if they can share them with their customers.

My answer is, “Yes, as long as you share only the article without any additions or alterations. In particular, you should avoid adding any mention of your company or your company’s products. If you were to do that, you could be making what the FTC and FDA consider a “misleading health claim” that could result in legal action against you and the company you represent.

For more detail about FTC regulations for health claims, see this link.

https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance

 _______________________________________________________________________

About The Author 

Dr. Chaney has a BS in Chemistry from Duke University and a PhD in Biochemistry from UCLA. He is Professor Emeritus from the University of North Carolina where he taught biochemistry and nutrition to medical and dental students for 40 years.  Dr. Chaney won numerous teaching awards at UNC, including the Academy of Educators “Excellence in Teaching Lifetime Achievement Award”. Dr Chaney also ran an active cancer research program at UNC and published over 100 scientific articles and reviews in peer-reviewed scientific journals. In addition, he authored two chapters on nutrition in one of the leading biochemistry text books for medical students.

Since retiring from the University of North Carolina, he has been writing a weekly health blog called “Health Tips From the Professor”. He has also written two best-selling books, “Slaying the Food Myths” and “Slaying the Supplement Myths”. And most recently he has created an online lifestyle change course, “Create Your Personal Health Zone”. For more information visit https://chaneyhealth.com.

For the past 45 years Dr. Chaney and his wife Suzanne have been helping people improve their health holistically through a combination of good diet, exercise, weight control and appropriate supplementation.

The Good News About Omega-3s And Stroke

by

How Do Omega-3s Affect The Two Types Of Stroke?

Author: Dr. Stephen Chaney 

strokeI am continuing my series on recent omega-3 breakthroughs. Last week I reviewed a study showing that the omega-3s EPA and DHA lowered blood pressure. Since high blood pressure is a major contributing factor to stroke risk, it only makes sense that EPA and DHA would also decrease the risk of strokes.

In last week’s article I mentioned that high blood pressure is called a silent killer. That is because the symptoms of high blood pressure are easy to ignore and often confused with other illnesses.

For many people the first indication they have a problem is when they have a stroke, which either kills them or forever impacts their quality of life. Let me share some statistics with you.

  • Every 40 seconds someone in the United States has a stroke. One in four adults over the age of 25 will have a stroke in their lifetime.
  • Every 4 minutes someone in the United States dies from a stroke. For many of them sudden death is the first indication they had a health problem.
  • The overall incidence of strokes has increased 60% in the last 20 years with most of that increase (65%) coming from younger adults (ages 20 to 45)
  • The cost of treatment, rehabilitation, and lost wages from stroke was $891 billion in 2020 and is projected to increase to $2.3 trillion in 2050.

Any way you look at it, the personal and financial costs of strokes are immense.

How Do Omega-3s Affect The Two Types Of Stroke?

There are two major kinds of stroke – ischemic stroke, which is caused by a thrombus (blood clot) in the carotid arteries leading to the brain, and hemorrhagic stroke, which is caused by bleeding from small blood vessels in the brain. Ischemic stroke accounts for around 85% of all strokes.

Ischemic strokes are caused by atherosclerosis, the buildup of fatty plaques in the walls of the carotid arteries, followed by the formation of a blood clot which lodges in the narrowed arteries. As you might expect, the prevention and treatment of ischemic strokes are similar to the prevention and treatment of heart attacks.

EPA and DHA have been shown to:

  • Reduce inflammation, which is associated with increased risk of heart disease and stroke.
  • Reduce blood pressure. High blood pressure damages the endothelial lining of blood vessels, which can lead to either build up of atherosclerotic plaque or rupturing of the blood vessels.
  • Reduce platelet aggregation and blood viscosity, which reduces the potential for inappropriate blood clots forming in the carotid arteries.

[When you cut yourself, you want a blood clot to form to stop the bleeding. That is an example of appropriate blood clot formation. However, when a blood clot forms within your arteries, it can prevent blood from reaching surrounding tissues. This is an example of inappropriate blood clot formation.]

  • Reduce the risk of atherosclerotic plaques rupturing. Rupturing of atherosclerotic plaques triggers blood clot formation, so this also decreases the risk of inappropriate blood clots forming in the carotid arteries.

Based on the known effects of EPA and DHA, it is not surprising that they would decrease the risk of ischemic strokes. But what about hemorrhagic strokes? Here the answer is not as clear cut.

  • In a previous clinical study 4 gm/day of purified EPA without DHA was associated with a slightly increased risk of bleeding events but did not increase the risk of hemorrhagic stroke.
  • High doses of pharmaceutical grade EPA have also been associated with a slightly increased risk of atrial fibrillation (Afib). In contrast, previous studies have shown that higher dietary intake of EPA + DHA are associated with a lower risk of Afib.

At present, we don’t know whether the increased risk of bleeding events and Afib are only seen at very high doses of omega-3s or are due to the use of pharmaceutical grade EPA without DHA and any of the other naturally occurring omega-3s.

However, this uncertainty has led some experts to warn that omega-3s may be a two-edge sword. They might increase the risk of hemorrhagic stroke while decreasing the risk of ischemic stroke. This uncertainty was part of the rationale for the study (JH O’Keefe et al, Stroke, 55: 50-58, 2024) I am describing today.

How Was This Study Done?

clinical studyThis study was a meta-analysis of 29 clinical studies looking at the effect of omega-3 fatty acids on the risk of both ischemic and hemorrhagic stroke. These studies were performed in 15 countries from around the world and included a total of 183,291 participants.

One major drawback of many meta-analyses is that each study in the meta-analysis is independently designed. Sometimes the studies are so different that it is difficult to fit them together in a coherent pattern.

A major strength of this meta-analysis is that all the studies were conducted within the “Fatty Acid and Outcome Research Consortium” which specifies a general protocol for the design of each study within that consortium.

For example, estimates of dietary omega-3 intake can be inaccurate and the uptake and utilization of both dietary and supplemental omega-3s vary from person to person. Because of that the Fatty Acid and Outcomes Research Consortium guideline specifies that studies rely on biomarkers of omega-3 levels in the body rather than the amount of omega-3s consumed.

The most frequently used biomarker was the percentage of omega-3s incorporated into the fatty portion of red blood cell membranes. Some studies used other biomarkers, such as the percentage of omega-3s incorporated into the fatty portion of plasma phospholipids or cholesterol-containing phospholipid particles (LDL and HDL for example).

In each case, the percentage of omega-3s is used to calculate something called an “Omega-3 Index”. Previous studies have shown that an Omega-3 Index of 4% or less correlates with a high risk of heart disease, and an Omega-3 Index of 8% or more correlates with a low risk of heart disease. In essence, this study correlated Omega-3 Index with the risk of stroke.

The Fatty Acids and Outcomes Research Consortium harmonized the studies included in this meta-analysis in several other ways, but the use of Omega-3 Index rather than omega-3 consumption was the most important.

Other key characteristics of the studies included in this meta-anaysis were:

  • The average age of participants was 65 years.
  • 82% of the participants were white and 53% were women.
  • The average length of follow-up was 14 years (range = 5-30 years).
  • 10,561 participants (5.8%) suffered a stroke during follow-up (78% ischemic, 11% hemorrhagic, and 11% unspecified).

The Good News About Omega-3s and Stroke 

good newsThe participants in these studies were divided into quintiles based on their Omega-3 Index. When those in the highest quintile (≥ 8%) were compared with those in the lowest quintile (≤ 4%):

  • Risk was reduced by 17% for total stroke and 18% for ischemic stroke. There was no effect on hemorrhagic stroke.

When the effect of individual components of the Omega-3 Index were analyzed:

  • For EPA + DHA risk was reduced by 17% for total stroke and 18% for ischemic stroke. There was no effect on hemorrhagic stroke.
  • For EPA risk was reduced by 17% for total stroke and 18% for ischemic stroke. There was no effect on hemorrhagic stroke. (You are probably starting to detect a pattern).
  • For DHA the results were only slightly different. Risk reduction was 12% for total stroke and 16% for ischemic stroke. There was no effect on hemorrhagic stroke.
  • For DPA, a minor component of the Omega-3 Index, there was no significant effect on total, ischemic, or hemorrhagic stroke.
  • There was a linear dose-response for the effect of EPA, DHA, and the two combined on the reduction in risk for both total and ischemic stroke.

When they looked at subgroups within the analysis, the results were the same for:

  • Age (<65 compared to >65).
  • Gender.
  • Studies that lasted less than 10 years and studies that lasted more than 10 years.
  • The presence of preexisting Afib.
  • The presence of preexisting cardiovascular disease.

The authors concluded, “In summary, this harmonized and pooled analysis of prospective studies showed that long-chain omega-3 levels were inversely associated with risk of total and ischemic stroke but were unrelated to risk of hemorrhagic stroke. Thus, higher dietary intake of DHA and EPA would be expected to lower risk of stroke.”

What Does This Study Mean For You?

Key Takeaways From This Study: The most important takeaway from this study is that reasonable amounts of EPA and DHA from either diet or supplementation are unlikely to increase your risk of hemorrhagic stroke (I will define reasonable below).

That is important to know because this and several other studies show that EPA and DHA decrease the risk of ischemic stroke, which accounts for around 85% of total strokes. This study shows you can reduce your risk of ischemic stroke without fearing that you will increase your risk of hemorrhagic stroke.

This study also reaffirms the importance of relying on Omega-3 Index rather than the dosage of omega-3s in a supplementation. Previous studies have shown there is significant individual variability in the uptake and utilization of dietary omega-3s.

Finally, this study shows you don’t need huge amounts of EPA and DHA to significantly decrease your risk of stroke and cardiovascular disease in general. An Omega-3 Index of ≥ 8% is sufficient to accomplish both.

How Much Omega-3s Do You Need? The authors of this manuscript are experts on the Omega-3 Index, and they estimated that:

  • To raise your Omega-3 Index from 5.4% (the median Omega-3 Index in these studies) to 8% would require about 1,000 mg/d of EPA + DHA.
  • To raise your Omega-3 Index from 3.5% (the lowest Omega-3 Index quintile in these studies) to 8% would require about 1,600 mg/d of EPA + DHA.

These intakes are well within the American Heart Association recommendations for reducing the risk of stroke and cardiovascular disease and are easily achievable from diet and supplementation.

But these estimates are based on averages, and, as I noted above, none of us are average. We differ in our ability to absorb and utilize omega-3s. So, I recommend relying on your Omega-3 Index rather than a dose of omega-3s that’s right for the average person but may not be right for you.

My recommendation would be to start with an Omega-3 test. If you are below 8%, start with the dosage of EPA + DHA the authors of today’s study recommended. Then retest in 6 months and adjust your dose based on the results of that test.

Question MarkHow Much Is Too Much? As I mentioned above, the dose response was linear for Omega-3 Index versus reduction in risk of total and ischemic strokes. So, the question becomes whether you might wish to increase your Omega-3 Index above 8% to achieve an even better reduction in stroke risk.

That is a very personal decision that only you can make but let me share some facts to help you make that decision.

  • As I mentioned above, a previous clinical trial showed an increased risk of bleeding events and Afib at a dosage of 4 gm/day of pure EPA. We don’t know whether that was because of the dose or the use of a formulation that contained only EPA without DHA and other naturally occurring long-chain omega-3s.
  • In that study the increase in bleeding events and Afib was observed in <5% of participants, which suggests that those side effects may be limited to certain high-risk individuals.
    • In this context, high risk might include individuals with preexisting Afib, individuals with a tendency towards excess bleeding, and patients on blood thinning medications.
    • However, only your physician knows all your risk factors. If you have health issues or are on medications, it is always a good idea to check with your physician before changing your omega-3 intake. And if you are considering high-dose omega-3 supplementation or exceeding an 8% Omega-3 Index, I strongly recommend that you consult with your physician first.

The Bottom Line

A recent study looked at the effect of omega-3 levels in red blood cells and other tissues (something called Omega-3 Index) on the risk of various types of stroke.

When individuals with an Omega-3 Index ≥ 8% were compared with those with an Omega-3 Index of ≤ 4%:

  • Risk was reduced by 17% for total stroke and 18% for ischemic stroke (stroke caused by blood clots in the carotid arteries). There was no effect on hemorrhagic stroke (stroke caused by bleeding from small blood vessels in the brain).

The authors concluded, “In summary, this harmonized and pooled analysis of prospective studies showed that long-chain omega-3 levels were inversely associated with risk of total and ischemic stroke but were unrelated to risk of hemorrhagic stroke. Thus, higher dietary intake of DHA and EPA would be expected to lower risk of stroke.”

This study represents an important breakthrough. There is good evidence that increased EPA + DHA from food and/or supplements reduces the risk of ischemic stroke. But some experts have cautioned it might also increase the risk of hemorrhagic stroke. This study puts that fear to rest.

For more details about the study and what it means for you, read the article above.

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure, or prevent any disease.

_______________________________________________________________________________

My posts and “Health Tips From the Professor” articles carefully avoid claims about any brand of supplement or manufacturer of supplements. However, I am often asked by representatives of supplement companies if they can share them with their customers.

My answer is, “Yes, as long as you share only the article without any additions or alterations. In particular, you should avoid adding any mention of your company or your company’s products. If you were to do that, you could be making what the FTC and FDA consider a “misleading health claim” that could result in legal action against you and the company you represent.

For more detail about FTC regulations for health claims, see this link.

https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance 

About The Author 

Dr. Chaney has a BS in Chemistry from Duke University and a PhD in Biochemistry from UCLA. He is Professor Emeritus from the University of North Carolina where he taught biochemistry and nutrition to medical and dental students for 40 years.  Dr. Chaney won numerous teaching awards at UNC, including the Academy of Educators “Excellence in Teaching Lifetime Achievement Award”. Dr Chaney also ran an active cancer research program at UNC and published over 100 scientific articles and reviews in peer-reviewed scientific journals. In addition, he authored two chapters on nutrition in one of the leading biochemistry text books for medical students.

Since retiring from the University of North Carolina, he has been writing a weekly health blog called “Health Tips From the Professor”. He has also written two best-selling books, “Slaying the Food Myths” and “Slaying the Supplement Myths”. And most recently he has created an online lifestyle change course, “Create Your Personal Health Zone”. For more information visit https://chaneyhealth.com.

For the past 45 years Dr. Chaney and his wife Suzanne have been helping people improve their health holistically through a combination of good diet, exercise, weight control and appropriate supplementation.

 

Which Diets Are Heart Healthy?

by

Which Diet Is Best For You?

Author: Dr. Stephen Chaney 

strong heartThe top 3 claims the advocates of every popular diet make are:

  • It will help you lose weight.
  • It reduces your risk of diabetes.
  • It reduces your risk of heart disease.

The truth is any restrictive diet helps you lose weight. And when you lose weight, you improve blood sugar control. Which, of course, reduces your risk of developing diabetes.

But what about heart disease? Which diets are heart healthy? When it comes to heart disease the claims of diet advocates are often misleading. That’s because the studies these advocates use to support their claims are often poor quality studies. Many of these studies:

  • Look at markers of heart disease risk rather than heart disease outcomes. Markers like LDL cholesterol, triglycerides, c-reactive protein, etc. are only able to predict possible heart disease outcomes. To really know which diets are heart healthy you have to measure actual heart disease outcomes such as heart attacks, stroke, and cardiovascular deaths.
  • Are too short to provide meaningful results. Many of these studies last only a few weeks. You need much longer to measure heart disease outcomes.
  • Are too small to provide statistically significant results. You need thousands of subjects to be sure the results you are seeing are statistically significant.
  • Have not been confirmed by other studies. The Dr. Strangeloves of the world like to “cherry pick” the studies that support the effectiveness of their favorite diet. Objective scientists know that any individual study can be wrong. So, they look for consensus conclusions from multiple studies.

A recent study (G Karam et al, British Medical Journal, 380: e072003, 2023) avoided all those pitfalls. The investigators conducted a meta-analysis of 40 high-quality clinical studies with 35,548 participants to answer the question, “Which diets are heart healthy?”

How Was The Study Done?

Clinical StudyThe authors started by searching all major databases of clinical studies for studies published on the effect of diets on heart disease outcomes through September 2021.

They then performed a meta-analysis of the data from all studies that:

  • Compared the effect of a particular diet to minimal dietary intervention (defined as not receiving any advice or receiving dietary information such as brochures or brief advice from their clinician with little or no follow-up).
  • Looked at heart disease outcomes such as all cause mortality, cardiovascular mortality, non-fatal heart attacks, stroke, and others.
  • Lasted for at least 9 months (average duration = 3 years).
  • Were high-quality studies.

Using these criteria:

  • They identified 40 studies with 35,548 participants for inclusion in their meta-analysis.
    • From those 40 studies, they identified 7 diet types that met their inclusion criteria (low fat (18 studies), Mediterranean (12 studies), very low fat (6 studies), modified fat (substituting healthy fats for unhealthy fats rather than decreasing fats, 4 studies), combined low fat and low sodium (3 studies), Ornish (3 studies), Pritikin (1 study).

One weakness of meta-analyses is that the design of the studies included in the meta-analysis is often different. Sometimes they don’t fit together well. So, while the individual studies are high-quality, a combination of all the studies can lead to a conclusion that is low quality or moderate quality.

Finally, the data were corrected for confounding factors such as obesity, exercise, smoking, and medication use.

Which Diets Are Heart Healthy?

Now that you understand the study design, we are ready to answer the question, “Which diets are heart healthy?” Here is what this study found:

Compared to minimal intervention,

  • The Mediterranean diet decreased all cause mortality by 28%, cardiovascular mortality by 45%, stroke by 35%, and non-fatal heart attacks by 52%.
  • Low fat diets decreased all cause mortality by 16% and non-fatal heart attacks by 23%. The effect of low fat diets on cardiovascular mortality and stroke was not statistically significant in this meta-analysis.
    • For both the Mediterranean and low fat diets, the heart health benefits were significantly better for patients who were at high risk of heart disease upon entry into the study.
    • The evidence supporting the heart health benefits for both diets was considered moderate quality evidence for this meta-analysis. [Remember that the quality of any conclusion in a meta-analysis is based on both the quality of evidence of the individual studies plus how well the studies fit together in the meta-analysis.]
  • While the percentage of risk reduction appears to be different for the Mediterranean and low fat diets, the effect of the two diets on heart health was not considered significantly different in this study.
  • The other 5 diets provided little, or no benefit, compared to the minimal intervention control based on low to moderate quality evidence.

The authors concluded, “This network meta-analysis found that Mediterranean and low fat dietary programs probably reduce the risk of mortality and non-fatal myocardial infarction [heart attacks] in people at increased cardiovascular risk. Mediterranean dietary programs are also likely to reduce the risk of stroke. Generally, other dietary programs were not superior to minimal intervention.”

Which Diet Is Best For You?

confusionThe fact that this study found both the Mediterranean diet and low fat diets to be heart healthy is not surprising. Numerous individual studies have found these diets to be heart healthy. So, it is not surprising when the individual studies were combined in a meta-analysis, the meta-analysis also concluded they were heart healthy. However, there are two important points I would like to make.

  • The diets used in these studies were designed by trained dietitians. That means the low fat studies did not use Big Food, Inc’s version of the low fat diet in which fatty foods are replaced with highly processed foods. In these studies, fatty foods were most likely replaced with whole or minimally processed foods from all 5 food groups.
  • The Mediterranean diet is probably the most studied of current popular diets. From these studies we know the Mediterranean diet improves brain health, gut health, and reduces cancer risk.

As for the other 5 diets (very low fat, modified fat, low fat and low sodium, Ornish, and Pritikin), I would say the jury is out. There is some evidence that these diets may be heart healthy. But very few of these studies were good enough to be included in this meta-analysis. Clearly, more high-quality studies are needed.

Finally, you might be wondering why other popular diets such as paleo, low carb, and very low carb (Atkins, keto, and others) were left out of this analysis. All I can say is that it wasn’t by design.

The authors did not select the 7 diets described in this study and then search for studies testing their effectiveness. They searched for all studies describing the effect of diets on heart health. Once they identified 40 high-quality studies, they grouped the diets into 7 diet categories.

I can only conclude there were no high-quality studies of paleo, low carb, or very low carb diets that met the criteria for inclusion in this meta-analysis. The criteria were:

  • The effect of diet on heart health must be compared to a control group that received no or minimal dietary advice.
  • The study must measure heart disease outcomes such as all cause mortality, cardiovascular mortality, non-fatal heart attacks, and stroke.
  • The study must last at least 9 months.
  • The study must be high-quality.

Until these kinds of studies are done, we have no idea whether these diets are heart healthy or not.

So, what’s the takeaway for you? Which diet is best for you? Both low fat diets and the Mediterranean diet are heart healthy provided the low fat diet consists of primarily whole or minimally processed foods. Which of these two diets is best for you depends on your food preferences.

The Bottom Line 

Many of you may have been warned by your doctor that your heart health is not what it should be. Others may be concerned because you have a family history of heart disease. You want to know which diets are heart healthy.

Fortunately, a recent study answered that question. The authors performed a meta-analysis of 40 high-quality studies that compared the effect of various diets with the effect of minimal dietary intervention (doctors’ advice or diet brochure) on heart disease outcomes.

From this study they concluded that both low fat diets and the Mediterranean diet probably reduce mortality and the risk of non-fatal heart attacks, and that the Mediterranean diet likely reduces stroke risk.

Other diets studied had no significant effect on heart health in this study. That does not necessarily mean they are ineffective. But it does mean that more high-quality studies are needed before we can evaluate their effect on heart health.

So, what’s the bottom line for you? Both low fat diets and the Mediterranean diet are heart healthy provided the low fat diet consists of primarily whole or minimally processed foods Which of these two diets is best for you depends on your food preferences.

For more information on this study, read the article above.

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure, or prevent any disease.

___________________________________________________________________________

My posts and “Health Tips From the Professor” articles carefully avoid claims about any brand of supplement or manufacturer of supplements. However, I am often asked by representatives of supplement companies if they can share them with their customers.

My answer is, “Yes, as long as you share only the article without any additions or alterations. In particular, you should avoid adding any mention of your company or your company’s products. If you were to do that, you could be making what the FTC and FDA consider a “misleading health claim” that could result in legal action against you and the company you represent.

For more detail about FTC regulations for health claims, see this link.

https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance

Is Whole Fat Dairy Healthy?

by

Is It Dairy Or Diet?

Author: Dr. Stephen Chaney 

CheesesFor years we have been told to select low fat dairy foods. But recent headlines claim, “That’s nonsense. Whole fat dairy foods are healthy.” Are those headlines true?

In previous issues of “Health Tips From the Professor” I have kept you abreast of recent studies suggesting that whole fat dairy foods may not be as bad for us as we thought. I also cautioned you that the headlines may not have accurately represented the studies they described.

Headlines have to be simple. But truth is often more nuanced. If we believed the current headlines, we might be asking ourselves questions like, “Should we ditch the current health guidelines recommending low-fat dairy foods? Are foods like ice cream, sour cream, and cheddar cheese actually be good for us?

To answer these questions, I will look at the study (A Mente et al, European Heart Journal, 44, 2560-2579, 2023) behind the current headlines and put the study into perspective.

Spoiler alert: If I could summarize the study findings in two sentences, they would be, “Whole fat dairy can be part of a healthy diet. But can it be part of an unhealthy diet?”

Stay tuned. I will discuss the science behind that statement below.

How Was This Study Done?

clinical studyThis study started with data collected from the Prospective Urban Rural Epidemiology (PURE) study. The PURE study is an ongoing study correlating diet, lifestyle, and environmental effects on health outcomes. It has enrolled 166,762 individuals, age 35-70, from 21 low-, middle-, and high-income countries on 5 continents.

Habitual food intake was determined using country-specific food frequency questionnaires at the time participants joined the study. Participants (166,762) from the PURE study who had complete dietary information were included in this study and were followed for an average of 9.3 years.

Based on preliminary analysis of data from the PURE study, the authors developed their version of a healthy diet, which they call the PURE diet. Like most other healthy diets, the PURE diet emphasizes fruits, vegetables, legumes, nuts, and fish. However:

  • Based on studies suggesting that whole fat dairy foods can be part of a healthy diet, the PURE diet includes whole fat dairy foods.

This is different from most other healthy diet recommendations.

They went on to develop what they referred to as the PURE healthy diet score by:

  • Determining the median intake for each of the 6 food groups included in their PURE diet (fruits, vegetables, legumes, nuts, fish, and whole fat dairy).
  • Assigning each participant in the study a score of 0 or 1 depending on whether their intake for that food group was below or above the median intake.
  • Adding up the points. Since 6 food groups were included in the PURE diet, this means that each participant in the study was assigned a PURE diet score ranging from 0-6.

Once they had developed a PURE diet score, they expanded their data by including five additional large independent studies that included people from 70 countries. The combined data from all six studies amounted to 245,597 people from 80 countries. Of the people included in the data analysis:

  • 21% came from high income countries.
  • 60% came from middle income countries.
  • 19% came from low-income countries.

This is very similar to the global population distribution. This is a strength of this study because it allowed them to ask whether the PURE diet score worked as well in low-income countries as in high-income countries.

Finally, they correlated the PURE diet score with outcomes like all-cause mortality, heart attack, and stroke.

Is Whole Fat Dairy Healthy?

QuestionsThe authors of this study divided the participants of all 6 studies into quintiles based on their PURE diet score and compared those in the highest quintile (PURE score of ≥ 5) with those in the lowest quintile (PURE score of ≤ 1).

The people in the highest quintile were eating on average 5 servings/day of fruits and vegetables, 0.5 servings/day of legumes, 1.2 servings/day of nuts, 0.3 servings/day of fish, 2 servings/day of dairy (of which 1.4 servings/day was whole fat dairy), 0.5 servings/day of unprocessed red meat, and 0.3 servings/day of poultry.

 

The people in the lowest quintile ate significantly less fruits, vegetables, nuts, fish, and dairy; and slightly less legumes, unprocessed red meat, and poultry than those in the highest quintile.

However, they consumed significantly more refined wheat foods and white rice. This study did not track consumption of highly processed foods, but the high consumption of white flour leads me to suspect they ate a lot more highly processed food.

With that in mind, when the authors compared people with the highest PURE diet scores to those with the lowest PURE diet scores:

  • All-cause mortality was reduced by 30%.
  • Cardiovascular disease was reduced by 18%.
  • Heart attacks were reduced by 14%.
  • Strokes were reduced by 19%.
  • The PURE healthy eating score was slightly better at predicting health outcomes than the Mediterranean, DASH, and HEI (Healthy Eating Index) scores. But the differences were small. So, I still recommend choosing the healthy diet that best fits your preferred foods and your lifestyle.
  • The PURE healthy eating score was significantly better at predicting health outcomes than the Planetary diet score. I will discuss the nutritional inadequacy of “sustainable diets” like the Planetary diet in next week’s “Health Tips From the Professor” article.

Because of the size and design of this study, they were able to make three interesting observations.

  1. The PURE, Mediterranean, DASH, and HEI diet scores were predictive of health outcomes in every country across the globe. You no longer have to wonder if what works in the United States will work in low-income countries and in countries with very different food preferences. Previous studies have not been able to make that claim.

2) You don’t have to be perfect.

    • A 20% increase (one quintile) in PURE score was associated with a 6% lower risk of major cardiovascular events and an 8% lower risk of mortality. In other words, even small improvements in your diet may improve your health outcomes.
    • The health benefits of the PURE diet started to plateau at a score of 3 (with 6 being the highest score). The authors concluded that most of the health benefits were associated with a modestly higher consumption of healthy foods compared to little or no consumption of healthy foods.

Simply put, that means the health benefits gained by going from a moderately healthy diet to a very healthy diet are not as great as the health benefits gained by going from a poor diet to a moderately healthy diet.

[Note: There are still improvements in health outcomes when you go from a moderately healthy diet to a very healthy diet.  My recommendation: “You don’t need to achieve perfection, but you shouldn’t accept mediocrity”.]

3) The PURE diet score was more predictive of health outcomes in some countries than in others.

    • The PURE diet score was more predictive of health outcomes in low-income countries. The authors felt that was because low-income countries started with average PURE scores of 2.1, whereas higher-income countries started with average PURE scores of 3.5.

The authors felt this was another example getting more “bang for the buck” by going from a poor diet to a moderately healthy diet than from a moderately healthy diet to a very healthy diet. (Remember, the health benefits associated with improving PURE diet scores start to plateau at a PURE score of 3.

    • The difference in benefits for low-income countries compared to high-income countries was observed for the Mediterranean, DASH, and HEI diet scores. So, it is probably safe to say for any healthy diet you don’t need to be perfect. You just need to be better.

The authors concluded, “A diet composed of higher amounts of fruit, vegetables, nuts, legumes, fish, and whole fat dairy is associated with a lower risk of cardiovascular disease and mortality in all world regions, especially in countries with lower income where consumption of these foods is low.”

Is It Dairy Or Diet?

CheesesThe headlines are telling us that recommendations to choose low-fat dairy products are out of date. They say there is no reason to fear whole fat dairy foods. They are good for you. Bring on the ice cream, sour cream, cream cheese, and high fat hard cheeses!

As usual, there is a kernel of truth in the headlines, but headlines have to be simple. And the latest headlines are an oversimplification of what the studies actually show. Let me provide perspective to the headlines by asking two questions.

#1: Is it dairy or diet? A major weakness of this and similar studies is that they fail to consider diet context. What do I mean by that? Let’s dig a little deeper into this study.

  • Let’s start with a description of the PURE diet. It is a diet that emphasizes fruits, vegetables, legumes, nuts, and fish. In other words, it is a primarily plant-based diet.
  • Although the authors keep referring to the diet as one that includes whole fat dairy. It would be more accurate to say that it includes dairy, which was 30% low-fat and 70% whole fat.
  • The authors said that removal of any one food group from this combination reduced the predictive power of the PURE diet. In other words, the beneficial effect of 70% whole fat dairy is best seen in the context of a primarily plant-based diet.
  • The PURE diet was most effective at predicting health outcomes in low-income countries where a significant percent of the population consumes a primarily plant-based diet because meats are expensive.

So, a more accurate description of this study would be it shows that a mixture of low-fat and whole-fat dairy foods are a healthy addition to a primarily plant-based diet. But that is too complicated for a headline.

#2: If whole fat dairy can be part of a healthy diet, can it also be part of an unhealthy diet?

To answer that question let’s compare the potential effects of whole fat dairy on a primarily plant-based diet compared to the typical American or European diet.

  • Milk and other dairy foods are excellent sources of calcium, vitamin B12, and iodine and good sources of protein, vitamin D, choline, zinc, and selenium – nutrients that are often low or missing in plant-based diet. And this is true whether the dairy foods are low-fat or whole fat.
  • Primarily plant-based diets tend to be low in saturated fat, so the potential negative effects of adding a small amount of saturated fat to the diet may be outweighed by the beneficial effects of the nutrients dairy foods provide.

On the other hand,

  • The typical American or European diet provides plenty of protein and vitamin B12 and significantly more choline, vitamin D, iodine, and zinc than a plant-based diet. The added nutrients from adding dairy foods to this kind of diet is still beneficial, but the benefits are not as great as adding dairy foods to a primarily plant-based diet.
  • If you read the American Heart Association statement on saturated fats, it does not say that any amount of saturated fat is bad for you. In fact, small amounts of saturated fats play some beneficial roles in our bodies. The American Heart Association says, “Eating too much saturated fat can raise the level of LDL cholesterol in your blood…[which] increases your risk of heart disease and stroke.”
  • Here is where the problem lies. The typical American or European diet already contains too much saturated fat. Whole fat dairy just adds to that excess.

So, the most accurate description of this study would be it shows that a mixture of low-fat and whole-fat dairy foods are a healthy addition to a primarily plant-based diet but may not be a healthy addition to the typical American diet. But that is way too complicated for a headline.

You are probably wondering what this means for you. Here are my recommendations.

If you eat like most Americans, you should continue to follow the current health guidelines to choose low-fat dairy foods.

If you happen to be among the few Americans who eat a primarily plant-based diet, you will probably benefit by adding a mixture of low-fat and whole fat dairy foods to your diet.

The Bottom Line 

Once again, the headlines are telling us that recommendations to choose low-fat dairy products are out of date. The articles say there is no reason to fear whole fat dairy foods. They are good for you. Bring on the ice cream, sour cream, cream cheese, and high fat hard cheeses!

As usual, there is a kernel of truth in the headlines, but headlines have to be simple. And the latest headlines are an oversimplification of what the studies actually show. In this post I looked at the study behind the most recent headlines and provided perspective to the headlines by asking two questions.

#1: Is it dairy or diet? A major weakness of this and similar studies is that they fail to consider diet context.

When you consider diet context a more accurate description of this study would be it shows that a mixture of low-fat and whole-fat dairy foods are a healthy addition to a primarily plant-based diet. But that is too complicated for a headline.

#2: If whole fat dairy can be part of a healthy diet, can it also be part of an unhealthy diet?

When you consider that question the most accurate description of this study would be it shows that a mixture of low-fat and whole-fat dairy foods are a healthy addition to a primarily plant-based diet but may not be a healthy addition to the typical American diet. But that is way too complicated for a headline.

You are probably wondering what this means for you. Here are my recommendations.

If you eat like most Americans, you should continue to follow the current health guidelines to choose low-fat dairy foods.

If you happen to be among the few Americans who eat a primarily plant-based diet, you will probably benefit by adding a mixture of low-fat and whole fat dairy foods to your diet.

For more information on this study, and the science behind my summary of the study, read the article above.

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure, or prevent any disease.

_________________________________________________________________________

My posts and “Health Tips From the Professor” articles carefully avoid claims about any brand of supplement or manufacturer of supplements. However, I am often asked by representatives of supplement companies if they can share them with their customers.

My answer is, “Yes, as long as you share only the article without any additions or alterations. In particular, you should avoid adding any mention of your company or your company’s products. If you were to do that, you could be making what the FTC and FDA consider a “misleading health claim” that could result in legal action against you and the company you represent.

For more detail about FTC regulations for health claims, see this link.

https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance

Are All Carbs Bad?

by

Are Low Carb Enthusiasts Right About The Dangers Of Carbohydrates?

Author: Dr. Stephen Chaney 

Low carb enthusiasts have been on the warpath against carbohydrates for years.

Almost everyone agrees that sugar-sweetened sodas and highly processed, refined foods with added sugar are bad for us. But low carb enthusiasts claim that we should also avoid fruits, grains, and starchy vegetables. Have they gone too far?

Several recent studies suggest they have. For example, both association studies and randomized controlled studies suggest that total carbohydrate intake is neither harmful nor beneficial for heart health.

In addition, recent studies suggest that free sugar intake is associated with both elevated triglyceride levels and an increase in heart disease risk.

But those studies have mostly looked at free sugar intake from sugar-sweetened sodas. The authors of this study (RK Kelley et al, BMC Medicine, 21:34, 2023) decided to look more carefully at the effect of all free sugars and other types of carbohydrates on triglyceride levels and heart disease risk.

How Was This Study Done?

clinical studyThe 110,497 people chosen for this study were a subgroup of participants in the UK Biobank Study, a large, long-term study looking at the contributions of genetic predisposition and environmental exposure (including diet) to the development of disease in England, Scotland, and Wales.

The participants in this study were aged between 37 and 73 (average age = 56) on enrollment and were followed for an average of 9.4 years. None of them had a history of heart disease or diabetes or were taking diabetic medications at the time of enrollment.

During the 9.4-year follow-up, five 24-hour dietary recalls were performed, so that usual dietary intake could be measured rather than dietary intake at a single time point. The people in this study participated in an average of 2.9 diet surveys, and none of them had less than two diet surveys.

The averaged data from the dietary recalls were analyzed for the amount and kinds of carbohydrate in the diet. With respect to the types of carbohydrate, the following definitions would be useful.

  • The term free sugars includes all monosaccharides and disaccharides added to foods by the manufacturer, cook, or consumer, plus sugars naturally present in honey, syrups, and unsweetened fruit juices.
  • The term non-free sugars includes all sugars not in the free sugar category, mostly sugars naturally occurring in fruits, vegetables, and dairy products.
  • The term refined grains includes white bread, white pasta, white rice, most crackers and cereals, pizza, and grain dishes with added fat.
  • The term whole grains includes wholegrain bread, wholegrain pasta, brown rice, bran cereal, wholegrain cereals, oat cereal, and muesli.

Finally, the study looked at the association of total carbohydrate and each class of carbohydrate defined above with all heart disease, heart attacks, stroke, and triglyceride levels.

Are All Carbs Bad?

Question MarkThe study looked at total carbohydrate intake, free sugar intake, and fiber intake. In each case, the study divided the participants into quartiles and compared those in the highest quartile with those in the lowest quartile.

Using this criterion:

  • Total carbohydrate intake was not associated with any cardiovascular outcome measured (total heart disease risk, heart attack risk, and stroke risk).
  • Free sugar intake was positively associated with all cardiovascular outcomes measured. Each 5% increase in caloric intake from free sugars was associated with a:
    • 7% increase in total heart disease risk.
    • 6% increase in heart attack risk.
    • 10% increase in stroke risk.
    • 3% increase in triglyceride levels.
  • Fiber intake was inversely associated with total heart disease risk. Specifically, each 5 gram/day increase in fiber was associated with a:
    • 4% decrease in total heart disease risk.

The investigators also looked at the effect of replacing less healthy carbohydrates with healthier carbohydrates. They found that:

  • Replacing 5% of caloric intake from refined grains with whole grains reduced both total heart disease risk and stroke risk by 6%.
  • Replacing 5% of caloric intake from free sugars (mostly sugar-sweetened beverages, fruit juices, and processed foods with added sugar) with non-free sugars (mostly fruits, vegetables, and dairy products) reduced total heart disease risk by 5% and stroke risk by 9%.

Are Low Carb Enthusiasts Right About The Dangers Of Carbohydrates?

With these data in mind let’s look at the claims of the low-carb enthusiasts.

Claim #1: Carbohydrates raise triglyceride levels. This study shows:

  • This claim is false with respect to total carbohydrate intake and high fiber carbohydrate intake (fruits, vegetables, and whole grains. This study did not measure intake of beans, nuts, and seeds, but they would likely be in the same category).
  • However, this claim is true with respect to foods high in free sugars (sugar-sweetened beverages, fruit juices, and processed foods with added sugar).

Claim #2: Carbohydrates increase heart disease risk. This study shows:

  • That claim is false with respect to total carbohydrate intake and high fiber carbohydrate intake.
  • However, this claim is true with respect to foods high in free sugars.

Claim #3: Carbohydrates cause weight gain [Note: Low carb enthusiasts usually word it differently. Their claim is that eliminating carbohydrates will help you lose weight. But that claim doesn’t make sense unless you believed eating carbohydrates caused you to gain weight.] This study shows:

  • This claim is false with respect to total carbohydrate intake and high fiber carbohydrate intake.
  • Once again, this claim is true with respect to foods high in free sugars.

The data with high fiber carbohydrates was particularly interesting. When the authors compared the group with the highest fiber intake to the group with the lowest fiber intake, the high-fiber group:

  • Consumed 33% more calories per day.
  • But had lower BMI and waste circumference (measures of obesity) than the low-carbohydrate group.

This suggests that you don’t need to starve yourself to lose weight. You just need to eat healthier foods.

And, in case you were wondering, the high fiber group ate:

  • 5 more servings of fruits and vegetables and…
  • 2 more servings of whole grain foods than the low fiber group.

This is consistent with several previous studies showing that diets containing a lot of fruits, vegetables, and whole grains are associated with a healthier weight.

The authors concluded, “Higher free sugar intake was associated with higher cardiovascular disease incidence and higher triglyceride concentrations…Higher fiber intake and replacement of refined grain starch and free sugars with wholegrain starch and non-free sugars, respectively, may be protective for incident heart disease.”

In short, with respect to heart disease, the type, not the amount of dietary carbohydrate is the important risk factor.

What Does This Mean For You?

Questioning WomanForget the low carb “mumbo jumbo”.

  • Carbohydrates aren’t the problem. The wrong kind of carbohydrates are the problem. Fruit juice, sugar-sweetened sodas, and processed foods with added sugar:
    • Increase triglyceride levels.
    • Are associated with weight gain.
    • Increase the risk for heart disease.
  • In other words, they are the villains. They are responsible for the bad effects that low carb enthusiasts ascribe to all carbohydrates.
  • Don’t fear whole fruits, vegetables, dairy, and whole grain foods. They are the good guys.
    • They have minimal effect on triglyceride levels.
    • They are associated with healthier weight.
    • They are associated with a lower risk of heart disease and diabetes.

So, the bottom line for you is simple. Not all carbs are created equal.

  • Your mother was right. Eat your fruits, vegetables, and whole grains.
  • Avoid fruit juice, sodas and other sugar-sweetened beverages, and processed foods with added sugar. [Note: Artificially sweetened beverages are no better than sugar-sweetened beverages, but that’s another story for another day.]

And, if you were wondering why low carb diets appear to work for weight loss, it’s because any restrictive diet works short term. As I have noted previously, keto and vegan diets work equally well for short-term weight loss.

The Bottom Line 

Low carb enthusiasts have been telling us for years to avoid all carbohydrates (including fruits, starchy vegetables, and whole grains) because carbohydrates:

  • Increase triglyceride levels.
  • Cause weight gain.
  • Increase our risk for heart disease.

A recent study has shown that these claims are only true for some carbohydrates, namely fruit juices, sodas and other sugar-sweetened beverages, and processed foods with added sugar.

Whole fruits, vegetables, and whole grain foods have the opposite effect. They:

  • Have a minimal effect on triglyceride levels.
  • Are associated with a healthier weight.
  • Are associated with a lower risk of heart disease and diabetes.

So, forget the low carb “mumbo jumbo” and be sure to eat your fruits, vegetables, and whole grains.

For more information on this study and what it means for you, read the article above.

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure, or prevent any disease.

___________________________________________________________________________

My posts and “Health Tips From the Professor” articles carefully avoid claims about any brand of supplement or manufacturer of supplements. However, I am often asked by representatives of supplement companies if they can share them with their customers.

My answer is, “Yes, as long as you share only the article without any additions or alterations. In particular, you should avoid adding any mention of your company or your company’s products. If you were to do that, you could be making what the FTC and FDA consider a “misleading health claim” that could result in legal action against you and the company you represent.

For more detail about FTC regulations for health claims, see this link.

https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance

Is Erythritol Bad For Your Heart?

by

Who Should Be Concerned About Erythritol Intake?

Author: Dr. Stephen Chaney 

Everyone is searching for the perfect sweetener. And if you were in the marketing department of Big Food Inc, the perfect sweetener would be defined as:

  • Natural, meaning that it is found in fruits, vegetables, or other plant foods.
  • Low in calories. Of course, a perfect sweetener would have zero calories because it is not metabolized in our bodies.
  • Low glycemic, meaning that it would have a minimal effect on blood sugar levels. Once again, a perfect sweetener would have zero effect on blood sugar levels.
  • Safe, meaning that it has no adverse effects on our health.

Sugar alcohols appear to meet all these criteria, so they have become the sweetener of choice for lots of highly processed foods. This is especially true for the sugar alcohol, erythritol, since it is currently the least expensive of the sugar alcohols.

So, a recent study (M Witowski et al, Nature Medicine, 2023) suggesting that erythritol might increase the risk of heart disease was quite surprising.

This is the first study to suggest a link between erythritol and heart disease, and it was a flawed study (I will discuss the flaws below).

Reputable scientists don’t put much credence in a weak first study like this one. We generally consider the conclusions of a first study like this one to be an unproven hypothesis at this point.

But we are cautious. There will be many follow-up, better designed studies, to test this hypothesis. Once these studies have been published, the scientific community will look at all the evidence and either issue a warning or conclude that there is no reason for concern.

But that doesn’t stop the Dr. Strangeloves of the world from warning you of the “dangers” of erythritol and telling you to avoid it at all costs.

For that reason, I felt it was appropriate to address this issue. I will:

  • Describe the study and its flaws.
  • Put the study into the broader perspective of what we know about sweeteners.
  • Identify the two population groups who should be most concerned about erythritol.

How Was The Study Done And What Did It Show?

This study can be divided into three parts.

heart disease#1: An Association Between Erythritol Blood Levels And Heart Disease.

There were three separate experiments included in this section of the study. In each experiment patients were recruited after visiting cardiac clinics for diagnostic procedures. The average age of these patients was 67 and 45% of them already had experienced a non-fatal heart attack prior to the study. In other words, these were all older patients with pre-existing heart disease who were at high risk of heart attack or stroke in the near future.

The first study was a metabolomic study. In simple terms this means that high-tech equipment and computing were used to measure hundreds of metabolites in the blood of the patients and, in this case, correlate each of them with the occurrence of heart attacks and strokes over the next three years.

  • This study identified 16 sugar alcohols and related metabolites in the blood of these patients that were associated with an increased risk of heart attack and stroke. (I will discuss the significance of this observation in more detail later.)

Because erythritol was among the top 6 compounds in terms of association with increased heart attack and stroke risk, and erythritol is the most commonly used sugar alcohol in processed foods, the next two studies focused on the association between blood levels of erythritol and heart attack/stroke risk. Their results were predictable.

  • High blood levels of erythritol were associated with an increased risk of heart attack and stroke over the next three years.

Flaws In This Portion Of The Study:thumbs down symbol

  • As the authors of the study pointed out, these studies were done with older patients with pre-existing heart disease who were at high risk of heart attack or stroke. They acknowledged that it is not known whether these associations exist with younger, healthier patients.
  • As the authors also pointed out, these are associations. They do not prove cause and effect. In particular, the studies did not measure the diet, exercise habits, and other lifestyle factors of these patients that may have contributed to their increased risk of heart attack and stroke.
  • When you look closely at the data, it is clear that the association is only seen at the highest blood levels of erythritol. Specifically, the blood levels of erythritol in these patients were divided into quartiles. The risk of heart attack and stroke in the first three quartiles (low to moderate blood levels of erythritol) were identical to the control. However, the fourth quartile (highest blood levels of erythritol) was associated with a dramatically increased risk of heart attack and stroke. That raises three important questions:
    • “How much erythritol were patients in the fourth quartile consuming?”
      • The authors did not look at dietary intake of erythritol but did note a previous study estimated that Americans consume up to 30 grams of erythritol a day.
    • 30 grams of erythritol a day is a huge amount of erythritol. Where does that erythritol come from?
      • Much of it comes from erythritol-containing highly processed foods like zero calorie sugar substitutes (either erythritol alone or erythritol mixed with artificial sweeteners to improve the taste); reduced- and low calorie carbonated and non-carbonated beverages; hard candy and cough drops, cookies, cakes, pastries, and bars; puddings and pie fillings; soft candies; syrups and toppings; ready to eat cereals; fruit novelty snacks; and frozen desserts.
      • But it is also found in foods you might not suspect, such as plant-based “milk” substitutes; chocolate and flavored milks; barbecue and tomato sauce, fruit-based smoothies, the syrup used in canned fruits, yoghurt; low calorie salad dressings; and salty snacks.
      • In other words, the only way anyone can consume 30 grams of erythritol in a day is to consume large quantities of erythritol-containing highly processed foods (I will discuss the significance of this observation later).
    • “What else was different about patients in the fourth quartile?”
      • When you look carefully at the data, the patients in the fourth quartile were significantly older, with a higher incidence of diabetes, pre-existing coronary artery disease, previous non-fatal heart attacks, congestive heart failure, and greater triglycerides – all of which significantly increase their risk of heart attack and stroke.

#2: Mechanistic Studies:

Next the authors did in vitro and animal studies looking at the effect of high levels of erythritol on blood clotting.

  • These studies showed that high levels of erythritol promoted blood clotting both in vitro and in mice. The authors concluded that these studies provided a plausible mechanism for a link between high erythritol blood levels and increased risk of heart attack and stroke.

Flaws In This Portion Of The Study:thumbs down symbol

  • Other critics have pointed out that the assays used were not accurate models of blood clotting in humans. This particular critique is beyond my expertise, so I won’t comment further. However:
    • As someone who was involved in cancer drug development for over 30 years, I know that in vitro and animal models are poor indicators of how things work in humans.
    • And as a biochemist, I have two concerns:
      • The authors provided no mechanistic rationale for why erythritol would enhance blood clotting.
      • The authors made no effort to show that the effect of erythritol was unique. Would high levels of other sugar alcohols or other naturally occurring sugars have the same effect on blood clotting in their assays? We don’t know.

#3: Blood Levels Of Erythritol After Oral Intake.

Finally, the authors gave subjects 30 grams of erythritol and measured blood levels over the next several days.

  • This experiment showed that very high blood levels of erythritol were attained and maintained for at least two days before gradually decreasing to baseline. The authors concluded this experiment showed that it was feasible to attain and maintain high blood levels of erythritol for several days following a single ingestion of 30 grams of erythritol.

Flaws In This Portion Of The Study:thumbs down symbol

  • I have already pointed out that 30 grams per day is a huge amount of erythritol. However, erythritol in the diet will come from a variety of foods, some of which will contain components (fiber etc.) that slow the absorption of erythritol.
  • In contrast, the subjects in this experiment were given 300 ml of liquid containing 30 grams of erythritol and told to drink it in two minutes!
  • In other words, these subjects were consuming 30 grams of erythritol in 2 minutes rather than 24 hours, and they were consuming it in the most easily absorbable form. For a study like this, that makes the effective dose orders of magnitude greater than the amount of erythritol that anyone consumes from their diet over a 24-hour period. The study design was completely unrealistic.

Is Erythritol Bad For Your Heart?

Question MarkAs described above, this is the first study to suggest an association between erythritol and heart disease, and it was a highly flawed study.

It is also important to know that erythritol is not an artificial sweetener. It is found naturally in foods like grapes, peaches, pears, watermelons, and mushrooms. It is also found in some fermented foods like cheese, soy sauce, beer, sake, and wine.

It is also a byproduct of normal human metabolism, so we always have some of it circulating in our bloodstream. Our body knows how to handle low to moderate intakes of erythritol.

However, to help you really understand what this study means, I need to put it into the context of other studies. I will do this in story form (You will find more details about these studies in my book “Slaying The Food Myths”).

First, let’s look at highly processed food consumption:

  • Multiple recent studies have shown that high consumption of highly processed food is associated with increased risk of obesity, diabetes, heart disease, and premature death. We don’t know what it is about highly processed food consumption that is responsible for the increased risk, but it is unlikely to be just one thing.
  • As I pointed out above, the only way to achieve the high blood levels of erythritol associated with increased heart disease risk is to consume large quantities of erythritol-containing highly processed foods.

Next, let’s follow the history of sweeteners in highly processed foods.

  • When I was a young man, sucrose (table sugar) was added to most highly processed foods. Sucrose is foundsugar cubes naturally in many fruits and vegetables. Small to moderate intake of sucrose in unprocessed and minimally processed foods posed no problem. However, large intakes of sugar in highly processed foods were found to increase the risk of obesity, diabetes, heart disease, and premature death.
  • At that point, sucrose became a “sugar villain”, and Big Food, Inc substituted fructose and high fructose corn syrup (a mixture of fructose and glucose) for sugar in their highly processed foods. As with sucrose, fructose is found naturally in many foods, and small to moderate intakes of fructose and high fructose corn syrup posed no health risks. However, large intakes of fructose and high fructose corn syrup in highly processed foods were found to increase the risk of obesity, diabetes, heart disease, and premature death.
  • Fructose and high fructose corn syrup then became the sugar villains. And because high fructose corn syrup is chemically and biologically indistinguishable from natural sugars like honey, date sugar, coconut sugar, it is likely that high intakes of these sugars in highly processed foods would cause the same problem.
  • So Big Food, Inc started relying on artificial sweeteners in their highly processed foods. But guess what? Artificial SweetenersRecent studies have suggested that artificial sweeteners in highly processed foods are associated with obesity, diabetes, and heart disease.
  • That has caused Big Food, Inc to rely more on sugar alcohols in their highly processed foods, particularly erythritol because it is the least expensive of the sugar alcohols. Now the current study comes along and suggests that high intake of erythritol in highly processed foods may increase the risk of heart disease.
  • If this hypothesis is confirmed by better designed studies, it is not clear what Big Food, Inc will do next. The metabolomic study described above showed that high blood levels of several other sugar alcohols are associated with an increased risk of heart disease.

Hopefully, you are starting to see a pattern here. It’s time to ask the question, “Is it the sweetener, or is it the food?”

Clearly, it doesn’t matter what sweetener we are talking about. Large intake of any natural sweetener in the context of a diet rich in highly processed foods appears to have an adverse effect on our health. And we don’t know whether these adverse health effects are caused by the sweetener or some other component of the highly processed foods.

If you want to improve your health, the best solution is to decrease your intake of highly processed foods. That will automatically reduce your intake of sweeteners and other unhealthy components of highly processed foods and increase your intake of healthy components from the whole foods you will be eating instead.

Who Should Be Concerned About Erythritol Intake?

The authors of this study identified two groups who should be most concerned about erythritol consumption – diabetics and adherents of the keto diet.

  • Diabetics are at high risk because they are told to consume non-caloric sweeteners instead of sugars, and they are not told to avoid highly processed foods. Consequently, they consume much higher amounts of non-caloric sweeteners than the average American.
  • I must admit that I didn’t foresee keto adherents as a high-risk group. However, it appears that keto enthusiasts love their sweets as much as the rest of us, and the sweetener of choice for keto-friendly sweets is erythritol. The authors said that a single serving of keto ice cream contains 30 grams of erythritol. I can hardly imagine how much erythritol they must be getting in their diet.

And, once again, the best advice for both groups is to simply decrease the amount of highly processed food in their diet.

The Bottom Line 

Erythritol is not an artificial sweetener. It is found naturally in foods like grapes, peaches, pears, watermelons, and mushrooms. It is also found in some fermented foods like cheese, soy sauce, beer, sake, and wine.

It is also a byproduct of normal human metabolism, so we always have some of it circulating in our bloodstream. Our body knows how to handle erythritol.

That is why it was a surprise when a recent study claimed that high intake of erythritol is associated with an increased risk of heart attack and stroke. The Dr. Strangeloves of the world are already starting to tell you that erythritol is deadly and you should avoid it at all costs. But reputable scientists are saying, “Not so fast”.

This is the first study to suggest an association between erythritol and heart disease, and it was a highly flawed study.

In fact, the study showed that low to moderate intakes of erythritol had no effect on heart disease risk. It was only the highest intake of erythritol that was associated with increased risk of heart disease. And given the distribution of erythritol in the American diet, the only way someone could take in that much erythritol is to consume large amounts of erythritol-sweetened highly processed foods.

A brief review of the literature on sweeteners reveals that this is a common pattern for every natural sweetener tested. Low to moderate intake of these sweeteners has no adverse health effects. However, high intake of every sweetener tested in the context of a highly processed food diet is associated with an increased risk of obesity, diabetes, heart disease, and premature death.

That raises the question, “Is it the sweetener, or is it the food?”

Clearly, it doesn’t matter what sweetener we are talking about. Large intake of any natural sweetener in the context of a diet rich in highly processed foods is likely to have an adverse effect on our health. And we don’t know whether these adverse health effects are caused by the sweetener or some other component of a highly processed food diet.

If you want to improve your health, the best solution is to decrease your intake of highly processed foods. That will automatically reduce your intake of sweeteners and other unhealthy components of highly processed foods and increase your intake of healthy components from the whole foods you will be eating instead.

For more details on the study and information about which foods are likely to contain erythritol and the population groups who should be most concerned about erythritol consumption, read the article above.

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure or prevent any disease

Does Red Meat Cause Frailty In Older Women?

by

Which Proteins Are Best?

Author: Dr. Stephen Chaney

Fatty SteakThe ads from the meat lobby say, “Red meat does a body good”. Are the ads true?

If we consider the health consequences of regularly eating red meat, the answer appears to be a clear, “No”. Multiple studies have shown a link between red meat consumption and:

  • Coronary heart disease.
  • Stroke
  • Type 2 diabetes.
  • Colon cancer, prostate cancer, and breast cancer.

And, if we consider the environmental consequences of red meat production, the answer also appears to be, “No”. I have discussed this in a recent issue of “Health Tips From the Professor”.

But what about muscle mass and strength? Red meat is a rich source of protein, and we associate meat consumption with an increase in muscle mass. Surely, red meat consumption must help us build muscle mass and strength when we are young and preserve muscle mass and strength as we age.

This is why the recent headlines claiming that red meat consumption increases the risk of frailty in older women were so confusing. I, like you, found those headlines to be counterintuitive. So, I have investigated the study (EA Struijk et al, Journal of Cachexia, Sarcopenia and Muscle, 13: 210-219, 2022) behind the headlines. Here is what I found.

How Was The Study Done?

Clinical StudyThis study utilized data acquired from the Nurses’ Health Study (NHS). The NHS began in 1976 with 121,700 female nurses aged 30 to 55. This study followed 85,871 nurses in the NHS once they reached age 60 for an average of 14 years.

Dietary intake was assessed using a food frequency questionnaire that was administered to all participants in the study every four years between 1980 and 2010. The long-term intake of red meat and other protein sources was based on a cumulative average of all available diet questionnaires for each participant.

The participants also filled out a Medical Outcomes Short Report every four years between 1992 and 2014. Data from this survey was used to calculate something called the FRAIL scale, which includes the following frailty criteria:

  • Fatigue
  • Low muscle strength.
  • Reduced aerobic capacity.
  • Having ≥5 of the following chronic diseases:
    • Cancer
    • High blood pressure
    • Type 2 diabetes
    • Angina
    • Myocardial infarction (heart attack)
    • Congestive heart failure
    • Asthma
    • COPD (chronic obstructive pulmonary disease)
    • Arthritis
    • Parkinson’s disease
    • Kidney disease
    • Depression
  • Greater than ≥5% weight loss in two consecutive assessments.

Frailty was defined as having met 3 or more criteria in the FRAIL scale. The study looked at the effect of habitual consumption of red meat or other protein sources on the development of frailty during the 14-year follow-up period.

Does Red Meat Cause Frailty In Older Women?

The investigators separated the participants into 5 quintiles based on total red meat consumption, unprocessed red meat construction, or processed red meat consumption. The range of intakes was as follows.

Total red meat: 0.4 servings per day to 1.8 servings per day.

Unprocessed red meat: 0.3 servings per day to 1.3 servings per day.

Processed red meat: 0.04 servings per day to 0.6 servings per day.

Clearly none of the women in this study were consuming either vegan or keto diets. As might be expected from a cross-section of the American public, there was a fairly narrow range of daily meat consumption.

Here are the results of the study:

  • Each serving per day of total red meat increased frailty by 13%.
  • Each serving per day of unprocessed red meat increased frailty by 8%.
  • Each serving per day of processed red meat increased frailty by 26%.
  • When each component of the frailty index was examined individually, all of them were positively associated with red meat consumption except for weight loss.

This was perhaps the most unexpected finding of the study. Not only did red meat consumption increased the risk of chronic diseases in these women, which would be expected from many previous studies. But red meat consumption also made these women more tired, weaker, and shorter of breath.

The authors concluded, “Habitual consumption of any type of red meat was associated with a higher risk of frailty.”

Which Proteins Are Best?

Red Meat Vs White MeatThe investigators then asked if replacing one serving/day of red meat with other protein sources was associated with a significantly lower risk of frailty. Here is what they found:

  • Replacing one serving per day of unprocessed red meat with a serving of:
    • Fish reduced frailty risk by 22%.
    • Nuts reduced frailty risk by 14%.
  • Replacing one serving per day of processed red meat with a serving of:
    • Fish reduced frailty risk by 33%
    • Nuts reduced frailty risk by 26%
    • Low-fat dairy reduced frailty risk by 16%
    • Legumes reduced frailty risk by 13%.

The authors concluded, “Replacing red meat with another source of protein including fish, nuts, legumes, and low-fat dairy may be encouraged to reduce the risk of developing frailty syndrome. These findings are in line with dietary guidelines promoting diets that emphasize plant-based sources of protein.” [I would note that fish and low-fat dairy are hardly plant-based protein sources.]

What Does This Study Mean For You?

Questioning WomanI am not yet ready to jump on the “eating red meat causes frailty” bandwagon. This is a very large, well-designed study, but it is a single study. It needs to be replicated by future studies.

And, as a biochemist, I am skeptical about any study that does not offer a clear metabolic rationale for the results. As I said earlier, increased protein intake is usually associated with an increase in muscle mass when we are young and a preservation of muscle mass as we age. There is no obvious metabolic explanation for why an increase in red meat consumption in older women would cause a decrease in muscle mass and other symptoms of frailty.

On the other hand, there are plenty of well documented reasons for decreasing red meat intake. Consumption of red meat is bad for our health and bad for the health of the planet as I have discussed in an earlier issue of “Health Tips From the Professor”. And substituting other protein sources, especially plant proteins, is better for our health and the health of our planet.

Finally, we also need to consider the possibility that this study is correct and that future studies will confirm these findings. Stranger things have happened.

As we age, we begin to lose muscle mass, a process called sarcopenia. Increased protein intake and resistance exercise can help slow this process. While I am not ready to say that red meat causes decreased muscle mass, I do think this study should make us think about which protein sources we use to prevent sarcopenia. At the very least we should not use age-related muscle loss as an excuse to increase our red meat intake. That might just be counterproductive.

The Bottom Line

A recent study looked at the effect of red meat consumption on frailty in older women. It came to the unexpected conclusion that:

  • Each serving per day of total red meat increased frailty by 13%.
  • Each serving per day of unprocessed red meat increased frailty by 8%.
  • Each serving per day of processed red meat increased frailty by 26%.
  • The increase in frailty could be reduced by replacing one serving/day of red meat with a serving of fish, nuts, low-fat dairy, or legumes.

I am not yet ready to jump on the “eating red meat causes frailty” bandwagon. This is a very large, well-designed study, but it is a single study. It needs to be replicated by future studies. And, as a biochemist, I am skeptical about any study that does not offer a clear metabolic rationale for the results.

On the other hand, there are plenty of well documented reasons for decreasing red meat intake. Consumption of red meat is bad for our health and for the health of the planet.

Finally, we also need to consider the possibility that this study is correct and that future studies will confirm these findings. Stranger things have happened.

As we age, we begin to lose muscle mass, a process called sarcopenia. Increased protein intake and resistance exercise can help slow this process. This study should make us think about which protein sources we use to prevent sarcopenia. At the very least we should not use age-related muscle loss as an excuse to increase our red meat intake. That might just be counterproductive.

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure or prevent any disease.

The Omega-3 Pendulum

by

Who Benefits Most From Omega-3s? 

Author: Dr. Stephen Chaney

Pendulum
Pendulum

If you were around in the 60’s, you might remember the song “England Swings Like a Pendulum Do”. It was a cute song, but it had nothing to do with pendulums. This week I am talking about something that really does resemble a pendulum – the question of whether omega-3s reduce heart disease risk.

There is perhaps nothing more confusing to the average person than the “truth” about omega-3s and heart disease risk. The headlines and expert opinion on the topic swing wildly between “omega-3s reduce heart disease risk” to “omega-3s have no effect on heart disease risk” and back again. To me these swings resemble the swings of a pendulum – hence the title of this article.

Part of the reason for the wild swings is that journalists and most “experts” tend to rely on the latest study and ignore previous studies. Another contributing factor is that most journalists and experts read only the main conclusions in the article abstract. They don’t read and analyze the whole study.

So, in today’s “Health Tips From the Professor” I plan to:

  • Analyze 3 major studies that have influenced our understanding of the relationship between omega-3 intake and heart disease risk. I will tell you what the experts missed about these studies and why they missed it.
  • Summarize what you should know about omega-3 intake and your risk of heart disease.

Why Is The Role Of Omega-3s In Preventing Heart Disease So Confusing?

SecretsIn answering that question, let me start with what I call “Secrets Only Scientists Know”.

#1: Each study is designed to disprove previous studies. That is a strength of the scientific method. But it guarantees there will be studies on both sides of every issue.

Responsible scientists look at all high-quality studies and base their opinions on the weight of evidence. Journalists and less-responsible “experts” tend to “cherry pick” the studies that match their opinions.

#2: Every study has its flaws. Even high-quality studies have unintended flaws. And I have some expertise in identifying unintended flaws.

I published over 100 papers that went through the peer review process. And I was involved in the peer review of manuscripts submitted by other scientists. In the discussion below I will use my experience in reviewing scientific studies to identify unintended flaws in 3 major studies on omega-3s and heart disease risk.

Next, let me share the questions I ask when reviewing studies on omega-3s and heart disease. I am just sharing the questions here. Later I will share examples of how these questions allowed me to identify unintended flaws in the studies I review below.

#1: How did they define heart disease? The headlines you read usually refer to the effect of omega-3s on “heart disease”. However, heart disease is a generic term. In layman’s terms, it encompasses angina, heart attacks, stroke due to blood clots, stroke due brain bleeds, congestive heart failure, impaired circulation, and much more.

Omega-3s have vastly different effects on different forms of heart disease, so it is important to know which form(s) of heart disease the study examined. And if the study included all forms of heart disease, it is important to know whether they also looked at the forms of heart disease where omega-3s have been shown to have the largest impact.

#2: What was the risk level of the patients in the study? If the patients in the study are at imminent risk of a heart attack or major cardiovascular event, it is much easier to show an effect than if they are at low risk.

For example, it is easy to show that statins reduce the risk of a second heart attack in someone who has just suffered a heart attack. These are high-risk patients. However, if you look at patients with high cholesterol but no other risk factors for heart disease, it is almost impossible to show a benefit of statins. These are low-risk patients.

If it is difficult to show that statins benefit low-risk patients, why should we expect to be able to show that omega-3s benefit low-risk patients?

[Note: I am not saying that statins do not benefit low-risk patients. I am just saying it is very difficult to prove they do in clinical studies.]

#3: How much omega-3s are the patients getting in their diet? The public reads the headlines. When the headlines say that omega-3s are good for their hearts, they tend to take omega-3 supplements. When the headlines say omega-3s are worthless, they cut back on omega-3 supplements. So, there is also a pendulum effect for omega-3 intake.

Omega-3s are fats. So, omega-3s accumulate in our cell membranes. The technical term for the amount of omega-3s in our cellular membranes is something called “Omega-3 Index”. Previous studies have shown that:

    • An omega-3 index of 4% or less is associated with high risk of heart disease, and…
    • An omega-3 index of 8% or more is associated with a low risk of heart disease.

When the omega-3 index approaches 8%, adding more omega-3 is unlikely to provide much additional benefit. Yet many studies either don’t measure or ignore the omega-3 index of patients they are enrolling in the study.

#4: How many and what drugs were the patients taking? Many heart disease patients are taking drugs that lower blood pressure, lower triglycerides, reduce inflammation, and reduce the risk of blood clot formation. These drugs do the same things that omega-3s do. This decreases the likelihood that you can see any benefit from increasing omega-3s intake.

The Omega-3 Pendulum

With all this in mind let’s examine three major double-blind, placebo-controlled studies that looked at the effect of omega-3s on heart disease risk and came to different conclusions. Here is a summary of the studies.

GISSI Study ASCEND Study VITAL Study
11,000 participants 15,480 participants 25,871 participants
Followed for 3.5 years Followed for 7.4 years Followed for 5.3 years
Europe USA USA
Published in 1999 Published in 2018 Published in 2019
Dose = 1 gm/day Dose = 1 gm/day Dose = 1 gm/day
20% ↓ in heart disease deaths No effect on fatal or non-fatal heart attack or stroke Significant ↓ in some forms of heart disease
45% ↓ in fatal heart attack or stroke – as effective as statins Significant ↓ in heart disease risk for some patients

heart attacksAt first glance the study designs look similar, so why did these studies give such different results. This is where the unintended flaws come into play. Let’s look at each study in more detail.

The GISSI Study:

  • The patients enrolled in this study all had suffered a heart attack in the previous 3 months. They were at very high risk of suffering a second heart attack within the next couple of years.
  • Omega-3 intake was not measured in this study. But it was uncommon for Europeans to supplement with omega-3s in the 90’s. And European studies on omega-3 intake during that period generally found that omega-3 intake was low.
  • Patients enrolled in this study were generally taking only 2 heart disease drugs, a beta-blocker and a blood pressure drug.

The ASCEND Study:

  • The patients enrolled in this study had diabetes without any evidence of heart disease. Only 17% of the flawspatients enrolled in the study were at high risk of heart disease. 83% were at low risk. Remember, it is difficult to show a benefit of any intervention in low-risk patients.
  • The average omega-3 index of patients enrolled in this study was 7.1%. That means omega-3 levels were near optimal at the beginning of the study. Adding additional omega-3s was unlikely to show much benefit.
  • Most of the patients in this study were on 3-5 heart drugs and 1-2 diabetes drugs which duplicated the effects of omega-3s.

That means this study was asking a very different question. It was asking whether omega-3s provided any additional benefit for patients who were already taking multiple drugs that duplicated the effects of omega-3s.

However, you would have never known that from the headlines. The headlines simply said this study showed omega-3s were ineffective at preventing heart disease.

Simply put, this study was doomed to fail. However, despite its many flaws the authors reported that omega-3s did reduce one form of heart disease, namely vascular deaths (primarily due to heart attack and stroke). Somehow this observation never made it into the headlines.

The VITAL Study:

  • This study enrolled a cross-section of the American population aged 55 or older (average age = 67). As you might suspect for a cross-section of the American population, most of the participants in this study were at low risk for heart disease. This limited the ability of the study to show a benefit of omega-3 supplementation in the whole population.

However, there were subsets of the group who were at high risk of heart disease (more about that below).

  • This study excluded omega-3 supplement users The average omega-3 index of patients enrolled in this study was 2.7% at the beginning of the study and increased substantially during the study. This enhanced the ability of the study to show a benefit of omega-3 supplementation.
  • Participants in this study were only using statins and blood pressure medications. People using more medications were excluded from the study. This also enhanced the ability of the study to show a benefit of omega-3 supplementation.

The authors reported that “Supplementation with omega-3 fatty acids did not result in a lower incidence of major cardiovascular events…” This is what lazy journalists and many experts reported about the study.

good newsHowever, the authors designed the study so they could also:

  • Look at the effect of omega-3s on heart disease risk in high-risk groups. They found that major cardiovascular events were reduced by:
    • 26% in African Americans.
    • 26% in patients with diabetes.
    • 17% in patients with a family history of heart disease.
    • 19% in patients with two or more risk factors of heart disease.
  • Look at the effect of omega-3s on heart disease risk in people with low omega-3 intake. They found that omega-3 supplementation reduced major cardiovascular events by:
    • 19% in patients with low fish intake.
  • Look at the effect of omega-3s on the risk of different forms of heart disease. They found that omega-3 supplementation reduced:
    • Heart attacks by 28% in the general population and by 70% for African Americans.
    • Deaths from heart attacks by 50%.
    • Deaths from coronary heart disease (primarily heart attacks and ischemic strokes (strokes caused by blood clots)) by 24%.

In summary, if you take every study at face value it seems like the pendulum is constantly swinging from “omega-3s reduce heart disease risk” to “omega-3s are worthless” and back again. There appears to be no explanation for the difference in results from one study to the next.

However, if you remember that even good studies have unintended flaws and ask the four questions I proposed Question Markabove, it all makes sense.

  • How is heart disease defined? Studies looking at heart attack and/or ischemic stroke are much more likely to show a benefit of omega-3s than studies that include all forms of heart disease.
  • Are the patients at low-risk or high-risk for heart disease? Studies in high-risk populations are much more likely to show a benefit than studies in low-risk populations.
  • What is the omega-3 intake of participants in the study? Studies in populations with low omega-3 intake are more likely to show a benefit of omega-3 supplementation than studies in populations with high omega-3 intake.
  • How many heart drugs are the patients taking? Studies in people taking no more than one or two heart drugs are more likely to show a benefit of omega-3 supplementation than studies in people taking 3-5 heart drugs.

When you view omega-3 clinical studies through the lens of these 4 questions, the noise disappears. It is easy to see why these studies came to different conclusions.

Who Benefits Most From Omega-3s?

omega 3s and heart diseaseThe answers to this question are clear:

  • People at high risk of heart disease are most likely to benefit from omega-3 supplementation.
  • People with low omega-3 intake are most likely to benefit from omega-3 supplementation.
  • Omega-3 supplementation appears to have the biggest effect on heart attack and ischemic stroke (stroke due to blood clots). Its effect on other forms of heart disease is less clear.
  • Omega-3 supplementation appears to be most effective at preventing heart disease if you are taking no more than 1 or 2 heart drugs. It may provide little additional benefit if you are taking multiple heart drugs. However, you might want to have a conversation with your doctor about whether omega-3 supplementation might allow you to reduce or eliminate some of those drugs.

What about the general population? Is omega-3 supplementation useful for patients who are at low to moderate risk of heart disease?

  • If we compare omega-3 studies with statin studies, the answer would be yes. Remember that statins cannot be shown to reduce heart attacks in low-risk populations. However, because they are clearly effective in high-risk patients, the medical community assumes they should be beneficial in low-risk populations. The same argument could be made for omega-3s.
  • We also need to recognize that our ability to recognize those who are at high risk of heart disease is imperfect. For too many Americans, the first indication that they have heart disease is sudden death!

When I was still teaching, I invited a cardiologist to speak to my class of first year medical students. He told the students, only partly in jest, that he felt statins were so beneficial they “should be added to the drinking water”.

I feel the same way about omega-3s:

  • Most Americans do not get enough omega-3s in our diet.
  • Our omega-3 index is usually much closer to 4% (high risk of heart disease) than 8% (low risk of heart disease).
  • Many of us may not realize that we are at high risk of heart disease until it is too late.
  • And omega-3s have other health benefits.

For all these reasons, omega-3 supplementation only makes sense.

The Bottom Line

There is perhaps nothing more confusing to the average person than the “truth” about omega-3s and heart disease risk. The headlines and expert opinion on the topic swing wildly between “omega-3s reduce heart disease risk” to “omega-3s have no effect on heart disease risk” and back again. To me these swings resemble the swings of a pendulum – hence the title of this article.

If you take every study at face value, there appears to be no explanation for the difference in results from one study to the next. However, if you recognize that even good studies have unintended flaws and ask four simple questions to expose these flaws, it all makes sense.

For the four questions you should ask when reviewing any omega-3 study and my recommendations for who benefits the most from omega-3 supplementation, read the article above.

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure, or prevent any disease.

Health Tips From The Professor