Do Omega-3s Reduce Osteoarthritis Pain?

How Do Rheumatoid And Osteoarthritis Differ?

Author: Dr. Stephen Chaney 

knee painThis week I am concluding my series on recent omega-3 advances by reviewing a meta-analysis that asks whether omega-3s are beneficial for people with osteoarthritis.

This is an important question because osteoarthritis affects around 32.5 million adults in the United States, and that number is increasing each year as our population ages. Osteoarthritis causes pain and disabilities that can significantly affect quality of life.

And the costs are high. Health care costs due to osteoporosis are around $140 billion/year. And when you include lost workdays, the annual cost is around $468 billion.

There are several medications for reducing symptoms of osteoarthritis. But they each have side effects and some patients cannot tolerate them. Joint replacement surgery is the final resort. But the recovery period is long, and the surgery isn’t always effective. For both reasons many patients with osteoarthritis are looking for natural solutions.

Most of the research on omega-3s and arthritis has been done with patients who have rheumatoid arthritis. Omega-3 supplements have been shown to reduce the pain, swelling of the joints, and inflammation associated with rheumatoid arthritis for many people with the disease.

Based on several dose-response studies, the NIH says the optimal dose is around 2.7 gm/day of EPA + DHA but cautions not to go above 3 gm/day without your doctor’s OK.

The evidence is less clear for omega-3s and osteoarthritis. Some studies suggest that EPA + DHA reduce the pain and inflammation associated with osteoarthritis. But other studies have come up empty. There is no consensus as to whether omega-3s are beneficial for people with osteoarthritis.

When there is disagreement between individual studies, a meta-analysis of the studies is often helpful. By pooling the data from multiple studies, a meta-analysis can smooth out some of the differences between the studies and accumulate enough data points to discover effects that would not have been statistically significant with the smaller data sets from individual studies.

With that in mind, the authors of this manuscript (W Den et al, Journal of Orthopaedic Surgery and Research, 18: 381, 3023) performed a meta-analysis on the data obtained from 9 double-blind, placebo-controlled studies looking at the effect of omega-3s versus a placebo on both pain and joint mobility in osteoarthritis patients.

How Do Rheumatoid And Osteoarthritis Differ?

While the causes of rheumatoid arthritis and osteoarthritis are very different, there are some underlying similarities between the two diseases that suggest both might benefit from omega-3 supplementation.

Rheumatoid Arthritis: Rheumatoid arthritis is thought to be an autoimmune disease, which means that our immune system attacks our cells rather than foreign invaders. It results in chronic inflammation that attacks our joints and can affect other tissues in our body.

It initially affects the lining of our joints which can result in painful, swollen joints. As the disease progresses it can also lead to bone erosion and joint deformity.

Osteoarthritis:Osteoarthritis is generally thought of as a “wear and tear” disease. It is associated with sports injuries and accidents. It is also associated with stress to particular joints due to repeated motions associated with either sports or a job. Obesity also increases wear and tear of the joints because it increases the load on the joints.

The wear and tear causes the cartilage that cushions the junction between bones to deteriorate. Eventually, the cartilage deteriorates to the extent that bone is grinding against bone, which can lead to bone loss and deformities.

Eventually, this results in an inflammation of the joint lining which causes pain and accelerates bone loss. It also causes deterioration of the connective tissue which holds bones together and connects them to muscle.

What Do These Diseases Have In Common? Inflammation is the common factor associated with both rheumatoid and osteoarthritis, and many studies suggest that omega-3s reduce inflammation. In the simplistic description of the two diseases I shared above, it sounds like inflammation occurs much earlier in the disease process for rheumatoid arthritis than for osteoarthritis. This might suggest that omega-3s could be more effective at reducing the symptoms and progression of rheumatoid arthritis than of osteoarthritis.

However, we know that the risk of developing osteoarthritis is increased by chronic inflammation caused by obesity, diseases like diabetes, and/or an inflammatory diet.

How Was This Study Done?

clinical studyThis study was a meta-analysis of 9 double-blind, placebo-controlled clinical studies looking at the effect of omega-3 fatty acids on the pain and loss of joint mobility associated with osteoarthritis. These studies were performed in countries from around the world and included a total of 2,070 participants.

The criteria for inclusion in the meta-analysis were:

1) The articles were written in English.

2) The studies had to be double-blind, placebo-controlled studies (The gold standard for clinical studies).

3) Patients with osteoarthritis were randomly assigned to an intervention group receiving omega-3 supplementation or a placebo group receiving olive oil or another plant oil.

4) The studies measured efficacy and safety outcomes including joint pain (efficacy), joint mobility (efficacy), and treatment-related adverse events (safety).

5) Patients in both the omega-3 and placebo groups were using medications to reduce osteoarthritis symptoms when they were enrolled in the study and were advised to continue with their prescribed medicines for the duration of the study.

The characteristics of the clinical studies included in this meta-analysis were:

  • Sample size (47-1221), Average = 230.
  • Mean age (55.9-68), Average = 63.
  • % men (13.8-45.1%), Average = 31%.
  • Omega-3 (EPA + DHA) dose (350 mg/day – 2,400 mg/day), Average = 1,085 mg/day.

Do Omega-3s Reduce Osteoarthritis Pain?

Question MarkWhen the data from all 9 studies were combined in a single meta-analysis, omega-3 (EPA + DHA) supplementation:

  • Reduced joint pain by 29% compared to the placebo.
  • Increased joint mobility by 21% compared to the placebo.
  • Was not associated with any adverse effects.

The authors concluded, “The results of the meta-analysis indicate that supplementation with omega-3 fatty acids is effective to relieve pain and improve joint function in patients with osteoarthritis, without increasing the risk of treatment-related adverse events. These findings support the use on omega-3 fatty acid supplementation as an alternative treatment for osteoarthritis.”

What Are The Strengths and Limitations Of This Study?

strengths and weaknessesStrengths:

  • All the studies included in this meta-analysis were randomized, double-blind, placebo-controlled studies (the gold standard for clinical trials).
  • All the individual studies that qualified for this meta-analysis found that omega-3 supplementation reduced joint pain and improved joint mobility. This improves confidence that the conclusions of the meta-analysis are correct. The meta-analysis simply improved the statistical significance of this conclusion by combining the data from the individual studies.

Limitations:

  • The biggest limitation was that the individual studies included in this meta-analysis were not performed under the guidelines of the “Fatty Acids and Outcomes Research Consortium” that I discussed in last week’s issue of “Health Tips From the Professor”.
    • The “Fatty Acids and Outcomes Research Consortium” guidelines harmonize the designs of individual studies, which strengthens the meta-analysis.
      • In contrast, the design of the individual studies within this meta-analysis was very different, which prevented the meta-analysis from being able to determine the optimal dose of omega-3 supplements and the minimum time required for omega-3 supplementation to significantly reduce the symptoms of osteoarthritis.
    • The “Fatty Acids and Outcomes Research Consortium” guidelines would have also required these studies to measure tissue levels of omega-3s (something called Omega-3 Index) at the beginning and end of each study. This was not done in any of these studies.
      • This is important because if a patient’s tissue levels of omega-3s at the beginning of the study were already in the optimal range, you would expect little additional benefit from supplementation for that patient.
  • All the individual studies were very small. This limits the ability of these studies to provide definitive conclusions. Unfortunately, this is probably unavoidable.
    • Double blind, placebo-controlled clinical studies are expensive. Only major pharmaceutical companies have the multi-million-dollar budgets required to conduct large double blind, placebo-controlled clinical studies that would provide more definitive evidence that omega-3 supplementation reduces the symptoms of osteoarthritis – and the follow-up studies that would determine the optimal dose of omega-3 supplements and the minimum time required to show an effect of omega-3 supplementation.
  • The patients in these studies were already taking medications to reduce their osteoarthritis symptoms prior to entering the study and were instructed to continue taking those medications during the study. This means that the studies were not asking whether omega-3s alone were effective at reducing osteoarthritis symptoms. They were asking whether omega-3 supplementation provided any additional benefits for people who were already taking medications to reduce symptoms.
    • Unfortunately, this is also probably unavoidable. Current guidelines consider it unethical to withhold the medical “standard of care” from any patient in a clinical trial.

What Does This Study Mean For You?

Questioning WomanThis study, while not definitive, strengthens the evidence that omega-3 supplements containing EPA + DHA may reduce joint pain and improve joint mobility for people with osteoarthritis. It also shows that the doses required to achieve these benefits are not associated with any significant side effects.

While large scale double blind, placebo-controlled clinical studies to confirm these conclusions would be nice, they are unlikely to occur for the reasons discussed above.

The investigators said, “[This study shows that] supplementation of omega-3 fatty acids is effective to relieve pain and improve joint function in patients with osteoarthritis…These findings support the use of omega-3 fatty acid supplementation as an alternative treatment for osteoarthritis.”

This might lead you to believe that omega-3 fatty acids can potentially replace medications for reducing osteoarthritis pain and loss of joint mobility. That may be true, but that is not what the study showed.

Patients in both the omega-3 and placebo group continued their prescribed medicines for osteoarthritis. In reality, the study only shows that omega-3s provide additional benefit for people already taking osteoarthritis medications. The effect of omega-3 supplements by themselves has not been tested and, as I discussed above, is not likely to be tested in the foreseeable future.

However, the use of omega-3 supplements may allow you to reduce or eliminate the medications you are on for osteoarthritis and may delay the need for joint replacement surgery. Of course, if you wish to reduce/eliminate your medications and/or delay joint replacement surgery, I recommend consulting with your doctor first.

Finally, this study provides no information on the optimal dose of omega-3s. Some studies suggest the dose of omega-3s needed to reduce osteoarthritis symptoms may be less than that required to reduce rheumatoid arthritis symptoms, but that evidence is weak.

In the absence of good dose response data, I recommend you aim for an omega-3 index of 8%. You will find a more detailed discussion of the Omega-3 Index and how to use it in last week’s “Health Tips From the Professor” article .

The Bottom Line

A recent meta-analysis looked at the effect of omega-3 supplementation on the pain and lack of joint mobility associated with osteoarthritis.

The study showed that omega-3 (EPA + DHA) supplementation:

  • Reduced joint pain by 29% compared to the placebo.
  • Increased joint mobility by 21% compared to the placebo.
  • Was not associated with any adverse effects.

The authors concluded, “The results of the meta-analysis indicate that supplementation with omega-3 fatty acids is effective to relieve pain and improve joint function in patients with osteoarthritis, without increasing the risk of treatment-related adverse events.”

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.

The Good News About Omega-3s And Stroke

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.

 

How Much Omega-3s Are Best For Blood Pressure?

What Does This Study Mean For You?

Author: Dr. Stephen Chaney

high blood pressureI am continuing my series on recent omega-3 breakthroughs. Today I am going to cover a recent systematic review and meta-analysis (X Zhang et al, Journal of the American Heart Association, 11: e025071, 2022) that analyzed 71 double blind, placebo-controlled clinical studies with 4,973 subjects to determine the optimal dose of omega-3s needed to lower blood pressure.

But first, I will cover why this study is so important.

High blood pressure is called a “silent killer”. For most of us our blood pressure creeps up year after year, decade after decade. Factors like inactivity, obesity, smoking, poor diet, and excess alcohol consumption speed the increase.

Unfortunately, the symptoms of high blood pressure – things like headaches, anxiety, fatigue, and blurred vision – are easy to ignore or confuse with other health problems. And if these symptoms are ignored long enough, the result can be sudden death due to a stroke or heart attack.

Alternately, the consequence could be things like congestive heart failure, kidney failure, vision loss, and memory loss that change your quality of life forever. And once the genie is out of the bottle, it can never be put back again. The damage is permanent.

Omega-3s are often recommended for keeping blood pressure in the normal range. In fact, in 2019 the FDA approved a qualified health claim stating, “Consuming eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega-3 fatty acids in food or dietary supplements may reduce the risk of hypertension (high blood pressure) and coronary heart disease.”

But the amount of omega-3s needed to reduce the risk of high blood pressure is uncertain. Previous studies have come up with conflicting results. That is the question the study I will discuss today was designed to answer.

How Was This Study Done?

Clinical StudyThe investigators included 71 studies published between 1987 and 2020 with a total of 4,793 subjects ranging in age from 22 to 86 years in their systematic review and meta-analysis. The studies were all randomized, placebo-controlled trials looking at the effectiveness of omega-3 intake (primarily in the form of food or supplements containing both EPA and DHA) at lowering blood pressure. The placebo used in these studies was olive oil or other vegetable oils.

The studies included in this meta-analysis:

  • Included omega-3 intake from both diet (mackerel, salmon, trout, or tuna) and supplements (fish oil, algal oil, or purified omega-3 ethyl esters).
  • Were conducted in populations from Europe, North America, Australia and other Pacific islands, and Asia.
  • Included subjects with normal blood pressure as well as those with high blood pressure.
  • Ranged in length from 5 to 52 weeks (the average was 10 weeks).
  • Included approximately equal numbers of men and women.

The meta-analysis excluded studies that:

  • Lacked a placebo.
  • Lasted less than 4 weeks.
  • Included blood pressure medications.
  • Included individuals with preexisting cardiovascular events.

The data from these trials was analyzed by a statistical method called a 1-stage cubic spline regression model. This is a recently developed statistical method which the investigators stated was superior to the statistical methods used in previous studies because it reduces the likelihood the results are influenced by investigator bias.

How Much Omega-3s Are Best For Blood Pressure?

Fish Oil and Blood PressureWhen the investigators combined the data from all 71 studies:

  • The maximum reduction in both systolic and diastolic blood pressure was observed between 2g/d and 3 g/d.
  • The dose response was non-linear. Doses above 3 g/d offered no additional benefit.

When the investigators looked at subgroups within the studies:

  • Reduction in blood pressure was seen in both subjects with normal blood pressure and those with high blood pressure.
    • However, reduction in blood pressure and the dose response were different in the two groups.
      • In subjects with normal blood pressure the dose response was non-linear with the optimum reduction between 2 and 3 g/d.
      • In subjects with high blood pressure the reduction in blood pressure was greater and the dose response was linear. The authors recommended a dose ≤ 3 g/d EPA + DHA for people with high blood pressure.
  • Subjects with hyperlipidemia had a greater reduction in blood pressure than subjects with normal lipid levels, and the dose-response was linear.
  • Subjects over the age of 45 had a greater reduction in blood pressure than subjects under the age of 45, and the dose response was linear.
  • There were no significant differences between:
    • Diet versus supplementation.
    • Type of omega-3 supplement (natural fish oil versus purified ethyl ester).
    • Sex.

The authors concluded, “This dose-response meta-analysis demonstrates that the optimal combined intake of omega-3 fatty acids for blood pressure lowering is likely between 2 g/d and 3 g/d. Doses of omega-3 fatty acid intake above the recommended 3 g/d may be associated with additional benefits in lowering blood pressure among groups at high risk of cardiovascular disease.”

I should probably explain the reasoning behind this conclusion.

  • 79% of the studies included in this meta-analysis were performed with subjects who had normal blood pressure. This group had a non-linear reduction in blood pressure with an optimal reduction between 2 and 3 g/d EPA + DHA.
    • Because of its size this group exerted a major influence on the results, which explains why the average results for the entire group showed a non-linear reduction in blood pressure with an optimal reduction between 2 and 3 g/d EPA + DHA.
    • Subjects with normal blood pressure and normal lipid levels are at low risk of cardiovascular disease. The high-risk groups (high blood pressure, high cholesterol and/or triglyceride levels, and over 45) all had a linear dose response suggesting that doses above 3 g/d EPA + DHA may be optimal.

The authors also said, “We found associations [between omega-3 intake and blood pressure] among both hypertensive (high blood pressure) and nonhypertensive (normal blood pressure) groups, suggesting that omega-3 fatty acids could be beneficial for controlling blood pressure even before the onset of hypertension.

This means that the intake of omega3 fatty acids could have implications on a person’s future risk of stroke, ischemic heart disease, and all-cause mortality.”

In other words, they are saying their data suggests that EPA + DHA intakes in the 2-3 g/d range may prevent high blood pressure and the effects it can have on our health.

What Does This Study Mean For You?

Question MarkThe authors of this study claim their data support a dose of 2-3 mg/d of EPA + DHA to prevent a future increase in blood pressure and all its associated health consequences. They also say that an EPA+ DHA dose ≥ 3g/d may be optimal for people who already have high blood pressure and/or other risk factors for heart disease.

I am not an expert on statistics, so I cannot evaluate the author’s claim that their statistical method was superior to the methods used in earlier studies that gave conflicting results.

However, their results are consistent with recommendations of several major health and government agencies.

  • For example, the European Food Safety Authority has said, “An intake of EPA and DHA of ~3 g/d is required to bring out the claimed hypotensive (blood pressure lowering) effect”.
  • The FDA has approved qualified health claims stating that consuming EPA and DHA in foods or dietary supplements may reduce the risk of hypertension (high blood pressure) and coronary heart disease but did not recommend a dose to achieve these results.
  • The American Heart Association has recommended ~ 1 g/d of EPA + DHA for patients with documented coronary heart disease and 2–4 g/day of EPA + DHA to lower triglycerides.
  • And the American Heart Association features this article on their website with the headline, “Consuming about 3 grams of omega-3 fatty acids a day may lower blood pressure.”

When we contrast that with the fact that the average American gets less than 100 mg/d of EPA + DHA from their diet it is obvious that many Americans would likely benefit from increasing the amount of EPA and DHA in their diet.

The Rest Of The Story

ProfessorThere are four additional points I would like to make:

  • In trying to explain the differences between dose response in high and low risk subjects, the authors said, “There could be mechanistic differences in bioavailability and efficacy of omega-3 fatty acid intake in these populations.”

In last week’s “Health Tips From the Professor” article I reviewed a study that measured individual differences in the utilization of EPA and DHA and concluded that a blood measurement called Omega-3 Index was a more reliable indicator of health outcomes than the dose of omega-3s consumed.

For that reason, I recommend personalizing your dose of EPA + DHA to reach an Omega-3 Index of 8%, which appears to be optimal for heart health and provides significant blood pressure reduction. This is an iterative process which will require frequent measurement of your omega-3 index and adjustment of EPA + DHA dose until you find the level of EPA + DHA supplementation you need to achieve an Omega-3 Index of 8%.

  • This study and similar studies measure the health benefits of the long chain omega-3 fatty acids EPA and DHA. Short chain omega-3s from nuts, seeds, and plant oils are healthy, but their conversion to EPA and DHA is very inefficient.
  • Both the FDA and American Heart Association recommend that doses of EPA + DHA above 3 g/d should be taken under a physician’s supervision because high doses can cause bleeding problems.

This is another reason for basing your intake of EPA + DHA on Omega-3 Index rather than on the dose recommended by a clinical study. Based on dozens of clinical studies, an Omega-3 Index of 8% appears to be safe unless you have a bleeding disorder or are on a blood-thinning medication (see below).

  • If you are on a medication to thin your blood, you should consult with your physician before increasing or decreasing your omega-3 intake because changes in dietary omega-3s can affect the optimal dose of medication they prescribe.

The Bottom Line 

A recent study looked at the dose of EPA + DHA needed to lower blood pressure.

  • The study concluded that a dose of 2-3 mg/d of EPA + DHA was optimal for preventing a future increase in blood pressure and all its associated health consequences.
  • It also concluded that an EPA+ DHA dose ≥ 3g/d was optimal for lowering blood pressure in people who already have high blood pressure and/or other risk factors for heart disease.
  • Based on previous studies, I recommend optimizing your omega-3 index rather than relying on a dose of EPA + DHA that may not be right for you.

For more details about this study and what it means to 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.

Do Omega-3s Improve Recovery From A Heart Attack?

Where Do We Go From Here? 

Author: Dr. Stephen Chaney 

Omega-3s And Heart DiseaseDespite years of controversy, the benefits of omega-3s remain an active area of research. Over the next few weeks, I will review several groundbreaking omega-3 studies. This week I will focus on omega-3s and heart health.

I don’t need to tell you that the effect of omega-3s on heart health is controversial. One month a new study is published showing an amazing health benefit from omega-3 supplementation. A month or two later another study comes up empty. It finds no benefit from omega-3 supplementation.

That leads to confusion. On one hand you have websites and blogs claiming that omega-3s are a magic elixir that will cure all your ills. On the other hand, there are the naysayers, including many health professionals, claiming that omega-3 supplements are worthless.

I have discussed the reasons for the conflicting results from omega-3 clinical studies in previous issues of “Health Tips From the Professor”. You can go to https://www.chaneyhealth.com/healthtips/ and put omega-3s in the search box to read some of these articles.

Or if you prefer, I have also put together a digital download I call “The Omega-3 Pendulum” which briefly summarizes all my previous articles. It’s available on my Chaney Health School Teachable website.

Today I will discuss a study (B Bernhard et al, International Journal of Cardiology, 399; 131698, 2024) that asks whether 6 months of high dose omega-3 supplementation following a heart attack reduced the risk of major cardiovascular events over the next 6.6 years.

You might be wondering why the study didn’t just look at the effect of continuous omega-3 supplementation for 6 years following a heart attack. There are two very good reasons for the design of the current study.

1) The investigators wanted to do a double blind, placebo controlled clinical trial, the gold standard for clinical studies. However, that kind of study is impractical for a multi-year clinical trial. It would be prohibitively expensive, and patient compliance would be a big problem for a study that long.

2) The months immediately after a heart attack are critical in determining the long-term recovery of that patient. There is often a period of massive inflammation following a heart attack. And that can lead to further damage to the heart and reclosing of the arteries leading to the heart, both of which increase the risk of future adverse cardiac events.

Previous studies have shown that high dose omega-3s immediately following a heart attack can reduce inflammation and damage to the heart. However, those studies did not determine whether the cardioprotective effect of omega-3 supplementation immediately after a heart attack lead to improved long-term outcomes, something this study was designed to determine.

How Was The Study Done?

clinical studyThe investigators enrolled 358 patients who had suffered a heart attack from three Boston area medical centers between June 2008 and August 2012.

The patient demographics were:

  • Gender = 70% female.
  • Average age = 59
  • Average BMI = 29 (borderline obese).
  • Patients with high blood pressure = 64%
  • Patients with diabetes = 25%.

The patients were divided into two groups. The first group received capsules providing 4 gm/day of EPA, DHA, and other naturally occurring omega-3 fatty acids. The other group received a placebo containing corn oil. This was a double-blind study. Neither the patients nor the investigators knew which patients received the omega-3 fatty acids and which ones received the placebo.

The patients were instructed to take their assigned capsules daily for 6 months. At the beginning of the study, blood samples were withdrawn to determine the percentage of omega-3s in the fatty acid content of their red cell membranes (something called omega-3 index). Patients were also tested for insulin resistance and given a complete cardiovascular workup. This was repeated at the end of the 6-month study.

[Note: Previous studies have shown that an omega-3 index of 4% or lower is associated with high risk of heart disease, and an omega-3 index of 8% or above is associated with a low risk of heart disease.]

At 2-month intervals the patients were contacted by staff using a scripted interview to determine compliance with the protocol and their cardiovascular health. Once the 6 months of omega-3 supplementation was completed, the patients were followed for an additional 6.6 years. They were contacted every 6 months for the first 3 years and yearly between 3 years and 6 years.

The investigators quantified the number of major cardiac events (defined as recurrent heart attacks, the necessity for recurrent coronary artery bypass grafts, hospitalizations for heart failure, and all-cause deaths) for each patient during the 6.6-year follow-up period.

Patients in both groups were treated according to current “standard of care” protocols which consisted of diet and exercise advice and 5-6 drugs to reduce future cardiovascular events.

Do Omega-3s Improve Recovery From A Heart Attack?

heart attacksWhen the investigators looked at the incidence of adverse cardiac events during the 6.6-year follow-up period, there were three significant findings from this study.

1) There were no adverse effects during the 6-month supplementation period with 4 gm/day of omega-3s. This is significant because a previous study with 4 gm/day of high purity EPA had reported some adverse effects which had led some critics to warn that omega-3 supplementation was dangerous. More study is needed, but my hypothesis is that this study did not have side effects because it used a mixture of all naturally occurring omega-3s rather than high purity EPA only. 

However, this could also have been because of the way patients were screened before entering this study. I will discuss this in more detail below.

2) When the investigators simply compared the omega-3 group with the placebo group there was no difference in cardiovascular outcomes between the two groups. This may have been because this study faced significant “headwinds” that made it difficult show any benefit from supplementation. I call them “headwinds” rather than design flaws because they were unavoidable. 

    • It would be unethical to deny the standard of care to any patient who has just had a heart attack. That means that every patient in a study like this will be on multiple drugs that duplicate the beneficial effects of omega-3 fatty acids – including lowering blood pressure, lowering triglycerides, reducing inflammation, and reducing plaque buildup and blood clot formation in the coronary arteries.

That means that this study, and studies like it, cannot determine whether omega-3 fatty acids improve recovery from a heart attack. They can only ask whether omega-3 fatty acids have any additional benefit for patients on multiple drugs that duplicate many of the effects of omega-3 fatty acids. That significantly reduces the risk of a positive outcome.

    • As I mentioned above, it would have been impractical to continue providing omega-3 supplements and placebos during the 6.6-year follow-up.

And the study was blinded, meaning that the investigators did not know which patients got the omega-3s and which patients got the placebo. That meant the investigators could not advise the omega-3 supplement users to continue omega-3 supplementation during the follow-up period.

Consequently, the study could only ask if 6 months of high-dose omega-3 supplementation had a measurable benefit 6.6 years later. I, for one, would be more interested in knowing whether lower dose omega-3 supplementation continued for the duration of this study reduced the risk of major coronary events.good news

3) When the investigators compared patients who achieved a significant increase in their omega-3 index during the 6-month supplementation period with those who didn’t, they found a significant benefit of omega-3 supplementation.

This was perhaps the most significant finding from this study.  

If the investigators had stopped by simply comparing omega-3 users to the placebo, this would have been just another negative study. We would be wondering why it did not show any benefit of omega-3 fatty acid supplementation.

However, these investigators were experts on the omega-3 index. They knew that there was considerable individual variability in the efficiency of omega-3 uptake and incorporation into cell membranes. In short, they knew that not everyone taking a particular dose of omega-3s will achieve the same omega-3 index.

And that is exactly what they saw in this study. All the patients in the 6-month omega-3 group experienced an increase in omega-3 index, but there was considerable variability in how much the omega-3 index increased over 6 months.

So, the investigators divided the omega-3 group into two subgroups – ones whose omega-3 index increased by ≥ 5 percentage points (sufficient to move those patients from high risk of heart disease to low risk) and ones whose omega-3 index increased by less than 5 percentage points.

When the investigators compared patients with ≥ 5% increase in omega-3 index to those with <5% increase in omega-3 index:

  • Those with an increase in omega-3 index of ≥ 5% had a 2.9% annual risk of suffering major adverse cardiac events compared to a 7.1% annual risk for those with an increase of <5%.
  • That’s a risk reduction of almost 60%, and it was highly significant.

The authors concluded, “In a long-term follow-up study, treatment with [high dose] omega-3s for 6 months following a heart attack did not reduce adverse cardiac events compared to placebo. However, those patients who were treated with omega-3s and achieved ≥ 5% rise in omega-3 index experienced a significant reduction of adverse cardiac events after a median follow-up period of 6.6 years…Additional studies are needed to confirm this association and may help identify who may benefit from omega-3 fatty acid treatment following a heart attack.”

What Does This Study Mean For You? 

Questioning WomanI should start by saying that I do not recommend 4 gm/day of omega-3 fatty acids following a heart attack without checking with your doctor first.

  • If you are on a blood thinning medication, the dose of either the medication or the omega-3 supplement may need to be reduced to prevent complications due to excess bleeding.
  • In addition, the investigators excluded patients from this study who might suffer adverse effects from omega-3 supplementation. This is a judgement only your doctor can make.

With that advice out of the way, the most important takeaway from this study is that uptake and utilization of omega-3 fatty acids varies from individual to individual.

The omega-3 index is a measure of how well any individual absorbs and utilizes dietary omega-3s. And this study shows that the omega-3 index is a much better predictor of heart health outcomes than the amount of omega-3 fatty acids a person consumes.

This is not surprising because multiple studies have shown that the omega-3 index correlates with heart health outcomes. It may also explain why many studies based on omega-3 intake only have failed to show a benefit of omega-3 supplementation.

Vitamin D supplementation is a similar story. There is also considerable variability in the uptake of vitamin D and conversion to its active form in the body. 25-hydroxy vitamin D levels in the blood are a marker for active vitamin D. For that reason, I have long recommended that you get your 25-hydroxy vitamin D level tested with your annual physical and, with your doctor’s help, base the dose of the vitamin D supplement you use on that test.

This study suggests that we may also want to request an omega-3 index test and use it to determine the amount of supplemental omega-3s we add to our diet.

Where Do We Go From Here?

Where Do We Go From HereThe idea that we need to use the omega-3 index to determine the effectiveness of the omega-3 supplement we use is novel. As the authors suggest, we need more studies to confirm this effect. There are already many studies showing a correlation of omega-3 index with heart health outcomes. But we need more double blind, placebo-controlled studies like this one.

More importantly, we need to understand what determines the efficiency of supplemental fatty acid utilization so we can predict and possibly improve omega-3 utilization. The authors suggested that certain genetic variants might affect the efficiency of omega-3 utilization. But the variability of omega-3 utilization could also be affected by:

  • Diet, especially the presence of other fats in the diet.
  • Metabolic differences due to obesity and diseases like diabetes.
  • Gender, ethnicity, and age.
  • Design of the omega-3 supplement.

We need much more research in these areas, so we can personalize and optimize omega-3 supplementation on an individual basis.

The Bottom Line 

A recent study asked whether high dose omega-3 supplementation for 6 months following a heart attack reduced major cardiac events during the next 6.6 years.

  • When they simply compared omega-3 supplementation with the placebo there was no effect of omega-3 supplementation on cardiac outcomes.
  • However, when they based their comparison on the omega-3 index (a measure of how efficiently the omega-3s were absorbed and incorporated into cell membranes), the group with the highest omega-3 index experienced a 60% reduction in adverse cardiac events over the next 6.6 years.

This is consistent with multiple studies showing that the omega-3 index correlates with heart health outcomes.

More importantly, this study shows there is significant individual variation in the efficiency of omega-3 absorption and utilization. It also suggests that recommendations for omega-3 supplementation should be based on the omega-3 index achieved rather than the dose or form of the omega-3 supplement.

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

_______________________________________________________________________

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.

Do Omega-3s Reduce Cognitive Decline?

Should You Supplement With Omega-3s?

Author: Dr. Stephen Chaney 

Cognitive-DeclineDo omega-3s reduce cognitive decline, or is this another nutrition myth?

There is certainly good reason to believe that the long chain omega-3s EPA and DHA are good for brain health.

  • DHA is an essential part of the membrane that coats our neurons. As such, it is a major component of our brains and plays an important role in its structural integrity.
  • While EPA is not found in the brain it reduces inflammation and improves blood flow to the brain, both of which are important for brain health.

But the role of DHA and EPA in reducing cognitive decline remains controversial. Some studies strongly support their role in slowing cognitive decline while other studies find no effect.

So, the question remains, “Do omega-3s reduce cognitive decline or not?”

The study (B-Z Wei et al, American Journal of Clinical Nutrition, 117: 1096-1109, 2023) I will review today was designed to answer that question.

This study supports the hypothesis that omega-3s, especially DHA and EPA, reduce cognitive decline and Alzheimer’s disease. But it also raises several questions that need to be resolved by future studies.

Why Is The Effect Of Omega-3s On Cognitive Decline Controversial?

ArgumentWhy is it so difficult to come up with definitive answers about whether omega-3s reduce cognitive decline? It is probably because the relationship between omega-3s and brain health is complex. For example:

  • Because omega-3’s beneficial effects are widely publicized, many people are already consuming adequate amounts of omega-3s. A supplement study that does not measure the omega-3 status of participants at the beginning of the study and does not focus on participants with inadequate omega-3 status is doomed to failure.
  • Omega-3s may benefit older people more than younger people. A study that is not large enough to measure the effect of omega-3s on both groups is doomed to failure.
  • The APOE ɛ4 genotype is associated with an increased risk of cognitive decline and Alzheimer’s. Some studies suggest omega-3s are more beneficial for people with the APOE ɛ4 genotype, while other studies come to the opposite conclusion. This is a critical variable that needs to be resolved.
  • The ability of DHA to cross the blood-brain barrier and accumulate in our brain may be influenced by our genetics, especially our APOE ɛ4 status, and adequate levels of other nutrients, especially B vitamins. Unless studies are large enough to separate out these variables, they are doomed to failure. This study suggests accumulation of DHA in the brain is a critical variable that needs to be resolved.
  • Multiple studies suggest that higher doses of omega-3s are more effective at reducing cognitive decline than low doses of omega-3s. This study confirms that effect and identifies a threshold dose that is needed to provide measurable benefits. Studies providing supplemental omega-3s at doses below that threshold are likely to fail. And meta-analyses that combine low dose studies with high dose studies are also likely to come up empty.
  • Finally, people who take omega-3s for years are likely to benefit more than those who take omega-3s for just a few months. Again, this study confirms that effect, which means that studies involving short-term supplementation with omega-3s are likely to fail. And meta-analyses that combine short-term and long-term studies are likely to come up empty.

With so many potential pitfalls, it is easy to understand why many studies come up empty, and the effect of omega-3s on cognitive decline remains controversial.

How Was This Study Done?

clinical studyThis study consisted of two parts:

Part 1 used data from the Alzheimer’s Disease Neuroimaging Initiative (ADNI). The ADNI study is a multicenter study designed to develop clinical, imaging, genetic, and biochemical markers for early detection and tracking of Alzheimer’s Disease.

Participants undergo standardized neuroimaging, psychological assessments, in-person interviews for medical history, and cognitive evaluations on entry into the study and at the end of the study.

This study followed a cohort of 1135 participants (average age = 73, 46% females) without dementia at entry into the study for 6 years.

Omega-3 supplement use was determined based on a questionnaire at the beginning of the study. Participants who used omega-3 supplements for over a year were considered omega-3 users. They were further divided into medium-term users (1-9 years) and long-term users (>10 years).

Alzheimer’s Disease was diagnosed by neurologists based on brain scans, cognitive scores, and the ability to live independently.

Part 2 was a meta-analysis of 31 studies with 103,651 participants. The studies included in the meta-analysis all:

  • Measured the relationship of omega-3 intake with the risk of Alzheimer’s Disease, all-cause dementia, or cognitive decline.
  • Were cohort studies (studies that follow a group of people over time) or case control studies (studies that compare people who develop a disease with those who do not).
  • Provided risk estimates or data that could be used to calculate risk.
  • Were original publications, not reviews or meta-analyses.

Do Omega-3s Reduce Cognitive Decline?

omega 3 supplementsThe results from Part 1 (data from the ADNI study) were as follows:

  • Omega-3 supplement users had a 37% lower risk of developing Alzheimer’s Disease than non-users.
  • Long-term (>10 years) omega-3 supplement users fared even better. They had a 64% lower risk of developing Alzheimer’s Disease than non-users.
  • When they broke the results for long-term omega-3 supplement users into subgroups:
    • Males (67% risk reduction) benefitted more than females (50% risk reduction).
    • People over 65 (65% risk reduction) benefited more than those under 65 (22% risk reduction).
    • People with the APOE ɛ4 genotype (71% risk reduction) benefitted more than those who were APOE ɛ4 negative (55% risk reduction).

The results from Part 2 (data from the meta-analysis) were as follows:

  • Dietary omega-3 intake lowered the risk of cognitive decline by 9%.
    • People with the APOE ɛ4 genotype fared better (17% risk reduction).
    • Their data suggested that a threshold of 1 gm/day omega-3s was needed before significant risk reduction was seen.
  • Dietary DHA intake lowered the risk of dementia by 27% and Alzheimer’s Disease by 24%.
  • Each 100 mg/day increase in DHA and EPA was associated with a significant reduction in the risk of cognitive decline (8% for DHA and 9.9% for EPA).

The authors concluded that,

1) “Long-term omega-3 supplementation may reduce risk of Alzheimer’s Disease; and

2) Dietary omega-3 fatty acid intake, especially DHA, may lower risk of dementia or cognitive decline…

3) However, further investigation is needed to understand the gene environment interactions involved in…[these effects of omega-3 fatty acids].”

Should You Supplement With Omega-3s?

QuestionsThis study provides strong support for the hypothesis that omega-3 supplementation reduces the risk of cognitive decline, dementia, and Alzheimer’s Disease as we age. It also suggests that a dose of 1 gram/day may be needed to obtain a significant benefit.

However, it also highlights the difficulty in designing definitive experiments to test this hypothesis. This study shows that gender, age, genetics (especially the APOE ɛ4 genotype), type of omega-3s, dosage, and duration of supplementation all exert a significant influence on the effect of omega-3s on cognitive decline.

It is extremely difficult to design a study that optimizes all these variables, which almost guarantees that the effect of omega-3s on cognitive decline will remain controversial for the foreseeable future.

However, omega-3s lower blood pressure, lower triglycerides, reduce inflammation and are heart-healthy. And the threshold for all these effects is around 1 gram/day or more. If omega-3s also reduce cognitive decline, you can consider that a side-benefit.

The Bottom Line 

The role of omega-3s in reducing cognitive decline remains controversial. Some studies strongly support their role in slowing cognitive decline while other studies find no effect.

So, the question remains, “Do omega-3s reduce cognitive decline or not?”

A recent study was designed to answer that question. Among other things the study showed:

  • Omega-3 supplement users had a 37% lower risk of developing Alzheimer’s Disease than non-users.
  • Long-term (>10 years) omega-3 supplement users fared even better. They had a 64% lower risk of developing Alzheimer’s Disease than non-users.
  • Dietary DHA intake lowered the risk of dementia by 27% and Alzheimer’s Disease by 24%.
  • Each 100 mg/day increase in DHA and EPA was associated with a significant reduction in the risk of cognitive decline (8% for DHA and 9.9% for EPA).
  • The threshold for observing a significant effect of omega-3s on cognitive decline was around 1 gram/day.

This study provides strong support for the hypothesis that omega-3 supplementation reduces the risk of cognitive decline, dementia, and Alzheimer’s Disease as we age. It also suggests that a dose of 1 gram/day may be needed to obtain a significant benefit.

However, it also highlights the difficulty in designing definitive experiments to test this hypothesis. This study shows that gender, age, genetics (especially the APOE ɛ4 genotype), type of omega-3s, dosage, and duration of supplementation all exert a significant influence on the effect of omega-3s on cognitive decline.

It is extremely difficult to design a study that optimizes all these variables, which almost guarantees that the effect of omega-3s on cognitive decline will remain controversial for the foreseeable future.

However, omega-3s lower blood pressure, lower triglycerides, reduce inflammation and are heart-healthy. And the threshold for all these effects is around 1 gram/day or more. If omega-3s also reduce cognitive decline, you can consider that a side-benefit.

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

 

 

Should Athletes Be Taking Omega-3s?

Can Omega-3s Protect Your Brain?

Author: Dr. Stephen Chaney 

Contact sports like football and soccer can be an athlete’s ticket to fame and fortune. That is a powerful motivator. But many elite athletes in contact sports pay a terrible price after their playing days are over.

Repeated head trauma can lead to a condition called Chronic Trauma Encephalopathy or CTE. In CTE, a protein called Tau forms clumps that spread through the brain, killing brain cells. Eventually, this can lead to irrational behavior and/or early-onset Alzheimer’s, which is, indeed, a terrible price to pay for their brief moment in the spotlight.

The NCAA is aware of the damaging effects of repeated head trauma and are experimenting with rule changes and improvements to protective head gear to reduce it. But, given the pressures of college teams to win at all costs, it will be impossible to completely eliminate head trauma from contact sports.

So, it is important to ask, “What else we can do?” Several studies have suggested that omega-3s may mitigate the damaging effect of repeated head trauma. For example:

  • The omega-3s DHA and EPA are metabolized to molecules called resolvins and protectins, which protect brain tissue from oxidative stress and help restore damaged brain tissue.
  • DHA and EPA also reduce the inflammation associated with brain injury, so the brain can heal faster.
  • DHA and EPA boost the level of a protein called BDNF in the brain. It helps trigger the production of new brain cells, which also aids in the recovery from brain injury.
  • Finally, some medical clinics have reported that high dose omega-3s help speed the recovery from severe head trauma.
  • This is concerning because omega-3s are largely missing from the diet of college athletes.

This raises the question, “Should athletes be taking omega-3s?”omega 3 supplements

The kinds of studies mentioned above suggest that DHA and EPA might help protect athletes from the damaging effects of repeated head trauma, but it is difficult to prove:

  • If a patient comes into a clinic with severe brain trauma, the symptoms are obvious. And if omega-3s speed recovery it will become apparent in weeks or months. This effect is easy to measure.
  • On the other hand, the effects of repeated, minor head trauma on a highly trained athlete are often not apparent until decades later. Therefore, any protective effects of omega-3s would also not become apparent for decades. Clinical studies don’t last that long.

Because of this, current research focuses on markers of brain damage such as neurofilament light chain or Nf-L. Nf-L is a neuronal protein that is released into the bloodstream by dying neurons. It is widely considered to be an early marker for neurodegenerative diseases such as those seen in former college football players. Previous studies have shown:

  • Nf-L blood levels increase during the season for NCAA-level college football players.
  • College football players have a very low omega-3 index, a measure of omega-3 status.
  • DHA supplementation reduces Nf-L levels in college football players.

With this in mind, the authors of this study (JL Heileson et al, Journal of the International Society of Sports Nutrition 18:65, 2021) looked at the effect of a high-dose, comprehensive omega-3 supplement on Nf-L levels in the blood of NCAA football players during the playing season.

How Was This Study Done?

clinical studyVolunteers from two geographically distinct NCAA football teams were recruited for this study. One team (n=31) was given a daily high-dose omega-3 supplement providing 2,000 mg of DHA, 560 mg of EPA, and 320 mg of DPA starting during pre-season (fall) practices and continuing through the entire season. Compliance with the supplement regimen was 93%.

Volunteers from the other team (n=35) received no supplements and served as a control.

Participants from both teams were advised which foods were high in omega-3s and were asked to limit servings to no more than 2 per week for the duration of the study.

Players were excluded from the study if they:

  • Were on long-term (>20 days) anti-inflammatory therapy.
  • Were using fish oil supplements.
  • Ate more than two servings of fish per week.
  • Were on medications to control blood pressure or blood lipid levels.

Blood samples were drawn 7 days before pre-season practice, at the end of pre-season practice, 3 times during the season, and at the end of the season (a total of 6 blood draws).

The blood samples were analyzed for Nf-L, a marker of brain injury, and Omega-3 Index, a measure of omega-3 status.

Should Athletes Be Taking Omega-3s?

As I stated above, compliance with the supplementation regimen was excellent (93%) and this was reflected in the blood levels of long-chain omega-3s. Between the first and last blood sample drawn:

  • DHA and EPA levels increased 2-fold.
  • DPA levels, on the other hand, decreased slightly.
    • This suggests that the beneficial effects of omega-3 supplementation were primarily due to DHA and EPA. I will discuss the implications of this below.
  • The omega-3 index increased from 4.3%, which is considered poor, to 7.4%, which is considered near optimal.

The effect of omega-3 supplementation on Nf-L levels was striking:

  • In the control team (no supplementation) Nf-L levels increased 1.5-fold during the pre-season practices and remained elevated throughout the regular season.
  • In the team receiving omega-3 supplementation there was no significant increase in Nf-L levels.

The authors of the study concluded, “These findings suggest a…neuroprotective effect of combined EPA+DPA+DHA omega-3 fatty acid supplementation in American-style football athletes.”

The authors went on to say, “Similar elevations of Nf-L have been reported with RHI [repeated head injuries] in other contact sport athletes. These data suggest that those other contact sports athletes may also benefit from omega-3 supplementation…”

So, let’s return to the original question, “Should athletes be taking omega-3s?” Here is my take on the study:

  • The conclusions of the authors are appropriately cautious. This study shows that omega-3 supplementation reduces an indicator of possible brain damage (Nf-L), but the actual symptoms of brain damage don’t appear for decades.
    • Therefore, this study suggests, but doesn’t prove, that omega-3 supplementation may reduce Chronic Trauma Encephalopathy (CTE) for athletes who competed in contact sports during their college years.
  • This study used an omega-3 supplement containing EPA, DHA, and DPA. It resulted in an increase in EPA and DHA levels, but not DPA levels. Thus, there is no evidence that the DPA portion of the supplement was needed. I recommend a supplement with a 4:1 ratio of DHA to EPA for brain health.
  • This study did not establish an optimal dose of omega-3s. Until more information is available, I would recommend around 2,000 mg of DHA and 500 mg of EPA for athletes in contact sports, but the optimal dose may be lower or higher.

Can Omega-3s Protect Your Brain?

If you are not a college athlete competing in contact sports (which would include most of us), you are probably wondering what this means for you. Here are my thoughts.

As Benjamin Franklin said, “An ounce of prevention is worth a pound of cure.”

  • You never know when you may suffer unexpected head trauma. It could be a car accident. It could be a fall. You might be playing a friendly game of softball and get hit in the head by a foul ball. You get the point.
  • And the best time to make sure you have enough omega-3s (specifically DHA + EPA) in your brain is before the trauma occurs.

But how much DHA + EPA is enough? This is where it gets confusing.

  • Recommendations range from 500 mg/day to 3,000 mg/day depending on whether the goal is to reduce death from heart disease, lower blood pressure, or lower triglycerides.
  • This study used 2,500 mg/day to reduce a marker of brain damage in college athletes, but we don’t know whether that is optimal.
  • Finally, these numbers are averages, and none of us are average. We all utilize omega-3s from supplements with different efficiencies.

My recommendation is to use the Omega-3 Index as a gauge. It tells us how much DHA + EPA we have actually accumulated in our tissues.

  • An Omega-3 Index of 8% is considered optimal for heart health, and this study suggests it might be optimal for brain health as well.
  • So, my recommendation is to get your Omega-3 Index measured at 6-month intervals until you have determined the amount of supplemental DHA + EPA you need to attain and maintain an 8% Omega-3 Index.
  • Based on this study, I would recommend a high-purity supplement with an ~4:1 ratio of DHA to EPA if your primary goal is brain health. But other studies suggest that an EPA to DHA ratio of 3:2 may be optimal for heart health.

In short:

  • While the evidence is not definitive, this study suggests that it might be prudent to have accumulated enough DHA and EPA in your neural tissue to help reduce the complications of unexpected brain trauma.
  • This study also suggests that you may wish to aim for an Omega-3 Index of 8%.
    • An Omega-3 Index of 8% likely has side benefits. There is also evidence that it may reduce the rate of cognitive decline as you age, help protect your heart, and reduce inflammation.
  • The ratio of DHA to EPA in the supplement you choose may be different for brain health and heart health. If you are equally interested in brain and heart health, just be sure your supplement provides both DHA and EPA.

The Bottom Line 

Repeated head injuries are a major concern for NCAA football players and college athletes in other contact sports. That’s because repeated head injuries during their playing years are associated with a degenerative brain condition called Chronic Trauma Encephalopathy or CTE, which can lead to irrational behavior and/or early-onset Alzheimer’s.

A recent study looked at the effect of a high-dose, comprehensive omega-3 supplement on Nf-L, a marker of brain injury, in NCAA football players during the playing season. Two teams were selected.

  • In the team receiving no omega-3s, Nf-L increased 1.5-fold during preseason practice and remained elevated throughout the playing season.
  • In the team receiving omega-3 supplementation there was no significant increase in Nf-L levels.

The authors of the study concluded, “These findings suggest a…neuroprotective effect of… omega-3 fatty acid supplementation in American-style football athletes.”

The authors went on to say, “Similar elevations of Nf-L have been reported with RHI [repeated head injuries] in other contact sport athletes. These data suggest that those other contact sports athletes may also benefit from omega-3 supplementation…”

For more information on this study and what it means for all of us who are not college athletes, 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

 

 

Can You Slow The Aging Process?

A Holistic Approach To Living Healthy Longer

Author: Dr. Stephen Chaney 

Fountain Of YouthEver since Ponce de Leon’s famed 1513 expedition, people have been searching for the proverbial “Fountain of Youth”.

There have been hucksters selling pills and potions to reverse the aging process. Most of them didn’t work. They were no better than snake oil.

There have been legitimate scientists investigating the effect of supplements, diets, and lifestyle on the aging process. Most of these studies have come up empty.

In this study (M Gagesch et al, Journal of Frailty And Aging, 12: 71-77, 2023) the authors hypothesized that a holistic approach might be better than individual interventions. They asked whether a combination of vitamin D3 supplementation, omega-3 supplementation, and exercise might be more effective at slowing the aging process than any one of them alone.

There was good reason for choosing each of these interventions:

  • Low 25-hydroxyvitamin D levels have been associated with frailty in several studies. But association studies do not prove cause and effect, and no randomized, placebo control studies have measured the effect of vitamin D supplementation on frailty.
  • Omega-3 fatty acids have been linked to skeletal muscle health, and some studies have suggested omega-3 supplementation may improve muscle function in older adults.
  • A recent study has reported that a supervised exercise program reduced frailty in older adults. The authors wanted to see if the same was true for unsupervised, at-home exercise program.

How Was This Study Done?

clinical studyThe data from this study were collected as part of the DO-HEALTH study, a 3-year, double-blind, randomized, placebo-controlled clinical trial designed to identify interventions that support healthy aging in European adults aged 70 and older.

Initially, 2,157 healthy, community-dwelling adults were enrolled from five countries (Switzerland, Germany, Austria, France, and Portugal). They were examined in clinical centers at the beginning of the study and years 1, 2, and 3, with phone follow-up at 3-month intervals.

Aging was measured by something called the frailty index. At each clinic visit the participants were evaluated in five areas:

  1. Weakness was measured as grip strength. Weakness was defined as being in the lowest quintile of grip strength for someone their age and gender.

2) Fatigue was defined as a positive answer to the question, “In the last month have you had too little energy to do the things you wanted to do?”

3) Involuntary weight loss was defined as >5% weight loss within a year.

4) Low gait speed was defined as <2 ft/sec walking speed.

5) Low activity level was defined as a response of, “Less than once a week” to the question, “How often do you engage in activities that require a low or moderate level of energy such as gardening, cleaning the car, or going on a walk?”

    • Participants with 0 positive items were classified as robust.
    • Those with 1 or 2 positive items were classified as pre-frail.
    • Those with 3 or more positive items were classified as frail.

Only those participants from the DO-HEALTH study classified as robust at the first clinical visit (1,137 participants) were included in this study. The study measured how many of them became pre-frail or frail during the average follow-up of 2.9 years.

The interventions were:

  • Capsules containing a total of 2,000 IU/day of vitamin D3 with sunflower oil capsules as a placebo.
  • Capsules containing a total of 1,000 mg of EPA and DHA in a 1:2 ratio with a sunflower oil capsule as a placebo.
  • Exercise consisting of an unsupervised strength-training routine for 30 minutes, 3 times per week.
  • In this case the control was an unsupervised joint-flexibility routine for 30 minutes, 3 times per week.

The interventions were done individually, two together (vitamin D + omega-3, vitamin D + exercise, omega-3 + exercise), and all three together (vitamin D + omega-3 + exercise).

The results were corrected for age, sex, and low-trauma falls in the preceding 12 months.

Finally, the study measured blood 25-hydroxyvitamin D levels and omega-3 levels at each office visit. They found:

  • 28% of the participants were deficient in vitamin D at the beginning of the study.
  • The interventions gave the expected increase in vitamin D and omega-3 status.

Can You Slow The Aging Process?

Older Couple Running Along BeachAt the end of 3 years:

  • 61.2% of the participants had declined from robust health to the pre-frail category.
  • 2.6% of the participants had declined from robust health to the frail category.

[Note: The terms “pre-frail” and “frail” are measures of aging which I have described above.]

The number of participants in the frail category were too small to obtain a statistically significant measure of the effects of vitamin D, omega-3s, and exercise on frailty, so I will only discuss the results measuring their effect on pre-frailty in this review. These results are:

  • None of these interventions had a statistically significant effect on aging by themselves, as measured by the transition from robust health to pre-frailty.
  • None of these interventions had a statistically significant effect on aging when combined in pairs, although the vitamin D3-omega-3 pair came close to significance (31% reduction in pre-frailty with a probability of 94% (probabilities of 95% and above are considered significant.))
  • However, the combination of vitamin D3, omega-3s, and exercise reduced the risk of aging by 39%, which was statistically significant (96% probability).

The authors concluded, “Robust, generally healthy and active older adults without major comorbidities [diseases], may benefit from a combination of high-dose, supplemental vitamin D3, marine omega-3s, and SHEP [unsupervised strength training] with regard to the risk of becoming pre-frail over 3 years.”

A Holistic Approach To Living Healthy Longer

holistic approachThis study was a double-blind, placebo-controlled study, which is the gold standard for clinical studies. It was also unusually large (1,137 participants) and long (3 years) for this kind of study.

It was also much better than most double-blind, placebo-controlled studies in that it included three interventions (vitamin D3 supplementation, omega-3 supplementation, and exercise) and looked at their effect on aging individually, in pairs, and all three together.

One take-home lesson from this study was that a holistic approach that included all 3 interventions was superior to any one of these interventions alone or in pairs.

But the most important take-home lesson is this:

If you asked your doctor what you should do to slow the aging process, he or she would probably tell you, “Exercise may help, but forget supplementing with extra vitamin D or omega-3s. They have no proven benefits.”

They would be correct based on studies of each of these interventions individually. And the studies they might quote would be double-blind, placebo-controlled studies, the gold standard of clinical studies.

But would that be the best advice. Clearly not. The best advice would be to follow a holistic approach and use all 3 interventions together.

Unfortunately, this is true for most studies of supplementation. Supplements are tested individually, as if they were “magic bullets”. And most of these studies come up short. They fail to find a significant benefit of supplementation.

Supplements are almost never tested holistically in combination with each other and other interventions, but that’s where the “magic” really happens.

If you are a regular reader of “Health Tips From The Professor”, this should come as no surprise to you. I have often shared the Venn diagram on the upper left and said that the sweet spot is when two or more of these interventions overlap.

Of course, this is the first study of its kind. More studies are needed. More importantly, we need studies to fill in the other parts of the Venn diagram. We need to ask about the effect of diet and obesity on aging. For example:

  • If we add a healthy diet to vitamin D, omega-3s, and exercise, can we reduce aging even more dramatically?
  • Is the effort it takes to lose excess weight worth it? Does adding it to diet, supplementation, and exercise reduce the aging process even more?

Of course, I think the answer to those questions is an unequivocal, “Yes”. Multiple studies have shown that both a healthy weight and a healthy diet help you live healthier longer.

But I am a scientist. Neither diet nor weight loss have been tested in combination with supplementation and exercise. I would like to see studies combining all these modalities in a single double-blind, placebo-controlled experiment.

So, what does this mean for you? If you want to slow the aging process, if you are in search of your personal “Fountain of Youth…

  • This study suggests that vitamin D3 supplementation (2,000 IU/day), omega-3 supplementation (1,000 mg of EPA + DHA), and an exercise program that emphasizes strength training can help you slow the aging process.

But that is only the beginning. I also recommend…

  • Including a healthy diet and a healthy weight in your anti-aging regimen.
  • Making sure your diet has enough protein and leucine, since older adults need more of both to maximize the benefits of strength training.
  • Including other supplements as evidence for their benefit in slowing the aging process becomes available.

The Bottom Line 

A recent double-blind, placebo-controlled study looked at the effect of vitamin D3 supplementation (2,000 IU/day), omega-3 supplementation (1,000 mg/day EPA + DHA in a 1:2 ratio), and an unsupervised strength training program on the aging process.

It differed from most other double-blind, placebo-controlled studies in that:

  • It was larger (1,137 participants) and longer (3 years) than most.
  • More importantly, each intervention was tested individually, in pairs, and all 3 together.

The study found that:

  • None of these interventions had a statistically significant effect on aging by themselves.
  • None of these interventions had a statistically significant effect on aging when combined in pairs, although the vitamin D3-omega-3 pair came close to significance.
  • However, the combination of vitamin D3, omega-3s, and exercise reduced the risk of aging by a statistically significant 39%.

One take-home lesson from this study was that a holistic approach that included all 3 interventions was superior to any one of these interventions alone or in pairs.

But the most important take-home lesson is this:

If you asked your doctor what you should do to slow the aging process, he or she would probably tell you, “Exercise may help, but forget supplementing with extra vitamin D or omega-3s. They have no proven benefits.”

They would be correct based on studies of each of these interventions individually. And the studies they might quote would be double-blind, placebo-controlled studies, the gold standard of clinical studies.

But would that be the best advice? Clearly not. The best advice would be to follow a holistic approach and use all 3 interventions together.

Unfortunately, this is true for most studies of supplementation. Supplements are tested individually, as if they were “magic bullets”. And most of these studies come up short. They fail to find a significant benefit of supplementation.

Supplements are almost never tested holistically in combination with each other and other interventions, but that’s where the “magic” really happens.

For more information on this study and my recommendations on how to slow the aging process 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 Vegan Breast Milk Sufficient?

What Can Vegan Moms Do?

Author: Dr. Stephen Chaney 

breastfeedingA whole food vegan diet is incredibly healthy:

  • Vegans are less likely to be overweight than the general population.
  • Vegans have a lower risk of diabetes, heart disease, cancer, hypertension, and several other diseases than the general population.
  • Whole food vegan diets are anti-inflammatory, so they lower the risk of autoimmune diseases and the “itis” diseases.

But vegan diets leave out meat, dairy, and eggs. Vegetarians without proper dietary advice are at high risk of inadequate intake of vitamin B12, vitamin D, iron, iodine, calcium, and DHA. And, of course, the risk of inadequate intake is even greater for vegans than it is for vegetarians, who may include some dairy and eggs in their diet.

So, it is legitimate to ask whether a vegetarian or vegan diet is sufficient for pregnancy and lactation. The short answer is that they can be if they are properly designed and properly supplemented.

But that is not an easy task, as evidenced by a recent study (N Ureta-Velasco et al., Nutrients 15:1855, 2023) comparing the breast milk of omnivore moms with the breast milk of vegetarian and vegan moms.

How Was This Study Done?

clinical studyThis study was done with 92 omnivore moms, 9 vegetarian moms (5-ovo-vegetarian and 4 lacto-ovo-vegetarians) and 11 vegan moms between August 2017 and February 2020 at the Regional Human Milk Bank at the “12 de Octubre” University Hospital in Madrid, Spain. The vegetarian and vegan moms were grouped together for data analysis.

On Day 0 of the study, participants went to the regional milk bank for blood and urine samples to determine nutritional status, a screening to determine health and socioeconomic status, and for food frequency questionnaire to characterize their habitual diet.

On days 1-5, they returned to the regional milk bank with a 24-hour diet recall of the previous day and to express 25 ml of breast milk to determine its nutrient content. On day 6, they returned to express a larger sample of breast milk to determine its lipid content (including EPA and DHA).

Note: Both the food frequency questionnaire and the 24-hour dietary recalls included nutrients derived from supplements.

What Did The Study Show About Dietary Intake of Key Nutrients?

Questioning WomanThis was a comprehensive study, so I will just cover the highlights here:

Birth Weight: Compared to the children of omnivore moms, the children of vegetarian/vegan moms were more likely to:

  • Have less weight gain during pregnancy (2 pounds less on average).
  • Be underweight at birth (60% of babies born to vegetarian/vegan moms were in the underweight category of birth weights versus 25% for babies born to omnivore moms).

This is probably because vegetarian/vegan moms:

  • Consumed slightly fewer calories per day (2146 versus 2319).
  • Consumed significantly less protein (67 g/d versus 96 g/d).
  • Were 10 times more likely to be underweight prior to pregnancy (10% versus 1%).

This is a concern because low birth weight increases the risk of physical and mental health issues later in life.

Supplement Use: The nutrients of greatest concern in a vegetarian/vegan diet are vitamin B12, vitamin D, iron, iodine, calcium, and DHA. For all these nutrients except DHA, this message appears to have gotten out to most vegetarian/vegan mothers because they were compensating for these potential deficiencies through supplementation.

For example, when they looked at average daily intake of these key nutrients from supplements, they found:

Nutrient Vegetarian/Vegan Moms Omnivore Moms
Vitamin D 1,080 IU (27mcg) 240 IU (6 mcg)
Folic acid 400 mcg 280 mcg
Vitamin B12 312 mcg 2 mcg
Calcium 566 mg 164 mg
Iron 40 mg 29 mg
DHA 100 mg 180 mg

However, that doesn’t tell the whole story, because not all vegetarian/vegan moms took supplements. When the investigators looked at the percent taking supplements, this is what they found.

Nutrient Vegetarian/Vegan Moms Omnivore Moms
Vitamin D 50% 50%
Folic acid 35% 61%
Vitamin B12 85% 60%
Calcium 15% 37%
Iron 25% 43%
DHA 10% 16%

Dietary Intake (Food + Supplements): The extra supplementation clearly played an important role because when the investigators looked at the overall intake from food and supplements, they found:

Nutrient Vegetarian/Vegan Moms Omnivore Moms
Vitamin D 224 IU (5.6 mcg) 432 IU (10.8 mcg)
Folate + Folic acid 668 mcg 473 mcg
Vitamin B12 258 mcg 6.9 mcg
Calcium 910 mg 1148 mg
Iron 31 mg 25 mg
DHA 110 mg 380 mg

Again, this doesn’t tell the whole story. Some women didn’t supplement. When the investigators looked at the percentage of women getting an inadequate intake of key nutrients from food plus supplements they found:

Nutrient Vegetarian/Vegan Moms Omnivore Moms
Vitamin D 75% 88%
Folate + Folic acid 0% 39%
Vitamin B12 25% 0%
Calcium 45% 40%
Iron Not reported Not reported
DHA Not reported Not reported

These results clearly show the need for supplementation. While the average intake from food plus supplements looked good, there were a significant percentage of women who weren’t getting adequate intake of key nutrients because they didn’t supplement.

The exceptions were folate + folic acid for vegetarian/vegans because their diet is rich in folate-containing foods and vitamin B12 for omnivores because their diet is rich in foods containing B12.

Is Vegan Breast Milk Sufficient?

Of course, the proof is in the pudding. When the investigators looked at the nutrient content of breast milk, this is what they found:

Nutrient Vegetarian/Vegan

Moms

Omnivore

Moms

Reference

Value*

Vitamin D3 1.1 mcg/L 3.4 mcg/L 0.25-2 mcg/L
Folate + Folic acid 19 mcg/L 20 mcg/l 80 mcg/L
Vitamin B12 0.74 mcg/L 0.65 mcg/L 0.5 mcg/L
Calcium 83 mg/L 99 mg/L 200-300 mg/L
Iron Not reported Not reported
DHA 0.15 g/100 g fat 0.33 g/100 g fat 0.35 g/100 g fat

*Reference values established by WHO

  • The chief difference between breast milk from vegetarian/vegan moms was in DHA levels.
  • That’s because the diet of vegetarians and vegans contains very little DHA, and very few vegetarian/vegan women in this study supplemented with DHA.
  • This study also found that breast milk from both vegetarian/vegan moms and omnivore moms was low in folate + folic acid, calcium, nicotinamide, and selenium. They said that requires follow-up in future studies.

The authors concluded, “The most important contribution of this study is the detailed and comprehensive description of micronutrients and lipids in human milk from omnivore milk donors and vegetarian/vegan women…Of particular concern is the lower DHA content in the milk of our vegetarian/vegan group. However, raising awareness and administering proper supplementation could bridge the gap, as has been the case with vitamin B12.”

What Can Vegan Moms Do?

This study emphasizes the importance of careful planning and supplementation during pregnancy and lactation if you are a vegetarian or vegan mom.

For example, the vegetarian/vegan women in this study were more likely to have low birthweight babies, and low birthweight infants are at risk for health issues later in life. That means:

  • Careful planning is required to select calorie- and protein-rich plant foods.
  • A high-quality plant protein supplement can be a great help.

Supplementation is particularly important during lactation to assure your breast milk adequately nourishes your newborn baby. For example, in this study:

  • The vitamin B12 level in the breast milk from vegetarian/vegan moms was adequate because 85% of them supplemented with vitamin B12.
  • The DHA level in the breast milk from vegetarian/vegan moms was inadequate because only 10% of them supplemented with DHA.
  • The authors of this study recommended that vegetarian and vegan moms consume at least 200 mg of DHA from algal sources while they are breastfeeding.

However, finding a prenatal supplement that provides all the nutrients you need prior to pregnancy, during pregnancy, and while breastfeeding is challenging. I gave you 7 tips for choosing the best prenatal supplements in a previous “Health Tips From the Professor” article.

The Bottom Line 

A recent study asked whether the breast milk of vegetarian and vegan moms was sufficient for the needs of their newborn babies. The study found that:

  • Folate levels in their breast milk were sufficient because the diets of vegetarians and vegans contain many folate-rich foods.
  • Vitamin B12 levels in their breast milk were sufficient because 85% of the vegetarian and vegan women in this study supplemented with vitamin B12.
  • DHA levels in their breast milk were insufficient because the diets of vegetarian and vegan women are very low in DHA, and only 10% of the women in this study supplemented with DHA.
  • The authors of this study recommended that vegetarian and vegan moms consume at least 200 mg of DHA from algal sources while they are breastfeeding.

This study reinforces the need for supplementation during lactation to assure your breast milk adequately nourishes your newborn baby.

However, finding a prenatal supplement that provides all the nutrients you need prior to pregnancy, during pregnancy, and while breastfeeding is challenging. I gave you 7 tips for choosing the best prenatal supplement in a previous “Health Tips From the Professor” article.

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 HDL Good For Your Heart?

Is Everything You Knew About HDL Wrong?

Author: Dr. Stephen Chaney 

HDL CHolesterolIn last week’s “Health Tips From the Professor” I talked about one of the greatest strengths of the scientific method – namely that investigators constantly challenge, and occasionally disprove, existing paradigms. That allows us to discard old models of how things work and replace them with better ones.

Last week I shared a study that disproved the paradigm that low to moderate alcohol consumption is healthier than total abstinence. This week I share several studies that challenge the belief that HDL cholesterol is good for your heart.

The belief that HDL is good for your heart has all the hallmarks of a classic paradigm.

  • It is supported by multiple clinical studies.
  • Elaborate metabolic explanations have been proposed to support the paradigm.
  • It is the official position of most medical societies, scientific organizations, and health information sites on the web.
  • It is the recommendation of most health professionals.
  • It has been repeated so often by so many trusted sources that everyone assumes it must be true.

Once we accept the HDL/heart health paradigm as true, we can construct other hypotheses on that foundation. For example:

  • Raising your HDL levels naturally takes effort. Pharmaceutical companies have been pursuing the “magic pill” that raises HDL levels without any effort on your part.
  • Low carb diets like the Keto and Paleo diets are high in saturated fat. The low carb enthusiasts claim this is a good thing because saturated fat raises HDL levels, and HDL is good for your heart.

But what if the underlying HDL/heart health paradigm weren’t true? These hypotheses would be like the parable of a house built on a foundation of sand. The paradigm will be washed away as soon as it is critically tested.

So, let’s look at experiments that have challenged the HDL/heart health paradigm.

Do Drugs That Increase HDL Levels Work?

The first hint that the HDL/heart health paradigm might be faulty happened when a pharmaceutical company developed a drug that selectively increased HDL levels.

The drug company thought they had found the goose that laid golden eggs. Just imagine. People wouldn’t have to lose weight, exercise, or change their diet. They could simply take a pill and dramatically decrease their heart disease risk. A drug like that would be worth $billions.

The problem was that when they tested their drug (torcetrapib) in clinical trials, it had absolutely no effect on heart disease outcomes (AR Tall et al, Atherosclerosis, Thrombosis, and Vascular Biology 27:257-260, 2007).

The pharmaceutical company couldn’t believe it. Raising HDL levels just had to reduce heart disease risk. They concluded they didn’t have the right drug, and they continued to work on developing new drugs.

That was 16 years ago, and no HDL-increasing drug has made it to market. Have they just not found the right drug, or does this mean the HDL/heart health paradigm is incorrect?

Does Saturated Fat Decrease Heart Disease Risk?

Now let’s turn to two claims of low carb enthusiasts.

#1: Saturated fats decrease your risk of heart disease in the context of a low carb diet. I have debunked that claim in several previous issues of “Health Tips From The Professor”. But let me refer you to two articles here – one on saturated fat and heart disease risk and one on low-carb diets.

#2: Saturated fats decrease heart disease risk because they raise HDL levels. This is the one I will address today.

The idea that saturated fats decrease heart disease risk because they raise HDL levels is based on a simplistic concept of HDL particles. The reality is more complex. Several clinical studies have shown:

  • The type of fat determines the property of the HDL particles.
    • When polyunsaturated fats predominate, the HDL particles have an anti-inflammatory effect. When saturated fats predominate, the HDL particles have a pro-inflammatory effect.
  • Anti-inflammatory HDL particles relax the endothelial cells lining our blood vessels. That makes the lining of our blood vessels more pliable, which improves blood flow and reduces blood pressure.
    • Anti-inflammatory HDL particles also help reduce inflammation of the endothelial lining. This is important because an inflamed endothelial lining is more likely to accumulate fatty plaques and to trigger blood clot formation that can lead to heart attacks and strokes.

So, the question becomes, “What good is it to raise HDL levels if you are producing an unhealthy, pro-inflammatory HDL particle that may increase the risk of high blood pressure, heart attacks, and strokes?”

In short, these studies suggest it isn’t enough to just focus on HDL levels. You need to ask what kind of HDL particles you are creating.

Is HDL Good For Your Heart?

strong heartOnce the studies were published showing that…

  • Drug-induced increase of HDL levels without any change in health habits is not sufficient to decrease heart attack risk, and…
  • Not all HDL particles are healthy. There are anti-inflammatory or pro-inflammatory HDL particles, which likely have opposite effects on heart attack risk…

…some people started to question the HDL/heart health paradigm. And one group came up with the perfect study to test the paradigm.

But before I describe the study, I need to review the term “confounding variables”. I described the term and how it affects clinical studies in last week’s article. Here is a brief synopsis:

  • The studies supporting the HDL/heart health paradigm are association studies. Association studies measure the association between a single variable (in this case, increase in HDL levels) and an outcome (in this case, heart disease events, heart disease deaths, and total deaths).
  • Associations need to be corrected for other variables known to affect the same outcome (things like age, gender, smoking, and diabetes would be examples in this case).
  • Confounding variables are variables that also affect the outcome but are unknown or ignored. Thus, they are not used to correct the associations, which can bias the results.

The authors of this study (M Briel et al, BMJ 2009:338.b92) observed that most interventions that increase HDL levels also lower LDL levels. Lowering LDL is known to decrease the risk of heart disease deaths. But this effect had been ignored in most studies looking at the association between HDL and heart disease deaths.

They hypothesized that the change in LDL levels was a confounding variable that had been ignored in previous studies and may have biased the results.Heart Disease Study

To test this hypothesis the authors searched the literature and identified 108 studies with 299,310 participants that:

  • Compared the effect of drugs, omega-3 fatty acids, or diet with either a placebo or usual care.
  • Measured both HDL and LDL levels.
  • Measured reduction in cardiovascular risk.
  • Had a randomized control design.
  • Lasted at least 6 months.

They found that every 10 mg/dl decrease in LDL levels in these studies was responsible for a:

  • 7.1% reduction in heart disease events (both heart disease deaths and non-fatal heart attacks).
  • 7.2% reduction in heart disease deaths.
  • 4.4% reduction in total deaths.

After correcting for the effect of decreased LDL levels on these heart disease outcomes, the increase in HDL levels had no statistically significant effect on any of the outcomes.

The authors concluded, “Available data suggest that simply increasing the amount of circulating HDL cholesterol does not reduce the risk of coronary heart disease events, coronary heart disease deaths, or total deaths. The results support reduction in LDL cholesterol as the primary goal for lipid modifying interventions.”

In other words, this study:

  • Supports the author’s hypothesis that LDL levels were a confounding variable that biased the studies supporting the HDL/heart health paradigm.
  • Concludes that increasing HDL levels has no effect on heart disease outcomes, thus invalidating the HDL/heart health paradigm.

Is Everything You Knew About HDL Wrong?

Peek Behind The CurtainDoes that mean that everything you knew about HDL is wrong? Not exactly. It just means that you need to change your perspective.

Don’t focus on HDL levels. Peek behind the curtain and focus on what’s behind the HDL levels. For example:

  • Losing weight when overweight increases HDL levels. But the decrease in heart disease outcomes is more likely due to weight loss than to the increase in HDL levels.
  • Exercise increases HDL levels. But the decrease in heart disease outcomes is more likely due to exercise than to the increase in HDL levels.
  • Reversing pre-diabetes or type 2 diabetes increases HDL levels. But the decrease in heart disease outcomes is more likely due to the reversal of diabetes than to the increase in HDL levels.
  • High-dose omega-3 fatty acids increase HDL levels. But the decrease in heart disease outcomes is more likely due to the omega-3 fatty acids than to the increase in HDL levels.
  • The Mediterranean diet increases HDL levels. But the decrease in heart disease outcomes is more likely due to the diet than to the increase in HDL levels.

And if you want to go the drug route:

  • Statins and some other heart drugs increase HDL levels, but the reduction in heart disease outcomes is probably due to their effect on LDL levels rather than their effect on HDL levels.

On the other hand:

  • Saturated fats increase HDL levels. But saturated fats increase heart disease risk and create pro-inflammatory HDL particles. So, in this case the increase in HDL levels is not a good omen for your heart.
  • Drugs have been discovered that selectively increase HDL levels. However, there is nothing of value behind this increase in HDL levels, so the drugs have no effect on heart disease outcomes.

The Bottom Line 

In this article I discuss several studies that have challenged the HDL/heart health paradigm – the belief that HDL is good for your heart.

For example, one group of investigators analyzed the studies underlying the HDL/heart health paradigm. They hypothesized that these studies were inaccurate because they failed to account for the effects of LDL levels on heart disease outcomes.

After correcting for the effect of decreased LDL levels on heart disease outcomes in the previous studies, the authors showed that increases in HDL levels had no significant effect on any heart disease outcome.

The authors concluded, “Available data suggest that simply increasing the amount of circulating HDL cholesterol does not reduce the risk of coronary heart disease events, coronary heart disease deaths, or total deaths. The results support reduction in LDL cholesterol as the primary goal for lipid modifying interventions.”

In other words, this study:

  • Supports the author’s hypothesis that LDL levels were a confounding variable that biased the studies supporting the HDL/heart health paradigm.
  • Concludes that increasing HDL levels has no effect on heart disease outcomes, thus invalidating the HDL/heart health paradigm.

Does that mean that everything you knew about HDL is wrong? Not exactly. It just means that you need to change your perspective. Don’t focus on HDL levels. Focus on what’s behind the HDL levels. For more information on that, read the article above.

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

Prenatal Supplements Strike Out Again

Is It Three Strikes And You Are Out?

Author: Dr. Stephen Chaney

Pregnant CoupleIf you are pregnant, you want the best for your unborn baby. Your doctor has recommended a prenatal supplement, but do the prenatal supplements on the market meet your needs? A few months ago, I shared two studies that concluded that most prenatal supplements on the market are woefully inadequate.

In fact, the authors said, “[Our] analysis found that prenatal supplements vary widely in content, often only contain a subset of essential vitamins, and the levels were often below…recommendations.”

In other words, their study found that most prenatal vitamins on the market may not be adequate to support your needs and the needs of your child through pregnancy and breastfeeding.

Now, a third study on the topic has been published (KA Saunders et al, American Journal of Clinical Nutrition, 117: 823-829, 2023. It differs from the previous studies in that:

1) The previous two studies took a comprehensive approach, while this study focused on 6 key nutrients.

  • The previous studies included all nutrients important for a healthy pregnancy including choline, iodine, and vitamin K, which have only recently been shown to be important for a healthy pregnancy.
  • This study focused on 6 nutrients, vitamin A, vitamin D, folic acid, calcium, iron, and omega-3 fatty acids, which have long been recognized as essential for a healthy pregnancy.

2) The previous two studies focused on prenatal supplements, while this study focused on all supplements that might be taken by pregnant women.

3) The previous two studies asked whether supplements provided recommended amounts of all nutrients needed for a healthy pregnancy. This study took a “Goldilocks approach” and asked whether levels of these 6 essential nutrients were appropriate (“just right”). The study:

  • Started by determining the intake of these 6 key nutrients by American women. The authors of the study then added the amount of each nutrient provided by the supplements in their study to the amount of that nutrient in the diet of American women and:
    • Calculated the minimum amount of each nutrient that would be needed to assure that 90% of American women taking a particular supplement would meet the recommended intake for pregnant and lactating women.
    • Calculated the maximum amount of each nutrient provided by supplements in their study to assure that that 90% of American women taking that supplement would not get potentially toxic amounts of that nutrient.
  • In other words, for each of the 6 nutrients they calculated a supplemental dose range that was neither too low nor too high. They called this the “appropriate dose range” for each nutrient. Goldilocks would have called it “just right”.

I’m sure you are anxiously waiting to learn what their study found. But before we go there, I will describe how the study was done.

How Was The Study Done?

clinical studyFor the dietary intake portion of the study, the authors used dietary intake data previously collected from the Environmental Influences on Child Health Outcomes (ECHO) study.

The ECHO study is a consortium of 69 medical centers across multiple states. It is an observational study of mothers and their offspring designed to understand the effects of early life exposures on child health and development.

The current study analyzed dietary intake data for 2450 participants from 6 medical centers across 5 states in the ECHO study. The women in this study were diverse with respect to ethnicity, education, and weight.

All pregnant women in the current study completed at least one 24-hour dietary recall between 6-week gestation until delivery (24% completed one dietary recall. 76% completed two or more dietary recalls). Dietary intake was generally assessed with an expert interviewer and included all foods and beverages consumed in the previous 24 hours.

For the supplement portion of the study, the authors used the NIH Dietary Supplement Label Database because it is the most complete listing of supplements in the US. The authors selected 20,547 supplements that contained at least one of the 6 essential nutrients from this database.

To determine which of the 20,547 supplements contained appropriate levels of the 6 nutrients (vitamin A, vitamin D, folic acid, calcium, iron, and omega-3 fatty acids) selected for this study, the authors used the process described in the introduction above. Briefly:

  • The authors added the amount of each nutrient provided by the supplements in their study to the amount of that nutrient in the diet of American women and:
  • Calculated the minimum amount of each nutrient that would be needed to assure that 90% of American women taking a particular supplement would meet the recommended intake for pregnant and lactating women.
  • Calculated the maximum amount of each nutrient provided by supplements in their study to assure that that 90% of American women taking that supplement would not get potentially toxic amounts of that nutrient.

In other words, for each of the 6 nutrients they calculated a supplemental dose range that was neither too low nor too high. They called this the “appropriate dose range” for each nutrient.

Why Are The 6 Nutrients Included In This Study Important?

Dietary Intake Is Often Inadequate

The diet analysis of pregnant American women in this study found:

  • 42% were at risk of inadequate vitamin A intake.
  • 96% were at risk of inadequate vitamin D intake.
  • 45% were at risk of inadequate folic acid intake.
  • 55% were at risk of inadequate calcium intake.
  • 93% were at risk of inadequate iron intake.
  • 67% were at risk of inadequate omega-3 intake.

The percentage of women at risk for inadequate intake of these nutrients varied with age, ethnicity, and income levels. But the overall message is clear. Most American women are not getting enough of these essential nutrients from their diet alone.

The Risk of Inadequate and Excessive Intake Of These Nutrients

These 6 nutrients were chosen in part because reviews by the Cochrane Collaboration have concluded that inadequate intake of these nutrients are associated with complications during pregnancy and delivery. They can also adversely affect the health and normal development of the baby.

This is important because the Cochrane Collaboration is considered the Gold Standard of clinical studies. You can find a more detailed description of Cochrane Collaboration studies and why they are the Gold standard here.

[Note: The Cochrane Collaboration has not yet evaluated choline, iodine, and vitamin K for pregnant women, but their inclusion in prenatal supplements is supported by multiple clinical studies.]

In addition, excess intake of all these nutrients except omega-3s can harm both the fetus and the mother. The is why the Food and Nutrition Board has set ULs (Upper Limits – the level above which toxicity can occur) for 5 of the 6 nutrients. This is important because previous studies have suggested that up to 25% of women may be getting toxic levels of one or more of these nutrients when you consider both their dietary intake and their prenatal supplement.

Summary

In other words, both too little and too much of these nutrients can harm the mom and her baby. It is critical that prenatal supplements get the dosing right.

It is for that reason that the authors of this study have set an “appropriate dose range” (high enough that 90% of women have enough of each nutrient to prevent deficiency and low enough that 90% of women do not exceed the UL for each nutrient) as the standard for evaluating the adequacy and safety of supplements for pregnant women.

Prenatal Supplements Strike Out Again

Of the 20,547 supplements (421 labeled as prenatal supplements) available on the US market as of December 31, 2022, the investigators reported that:

  • Only 69 (0.3%) supplements contained all 6 nutrients considered essential for a healthy pregnancy.
  • Only 1 supplement contained all 6 nutrients at the appropriate doses, and it wasn’t even labeled as a prenatal supplement.

In addition:

  • One supplement containing all 6 nutrients put 100% of the women in their study at risk for excessive intake of folic acid.
  • Another supplement containing all 6 nutrients put 46% of the women in their study at risk of inadequate calcium intake.

The authors concluded, “Almost no US dietary supplements provide key nutrients in the doses needed for pregnant women. Affordable and convenient products that fill the gap between food-based intake and estimated requirements of pregnancy without inducing excess intake are needed to support pregnant women and their offspring.”

In short, the conclusion of this study can be summed up as, “Prenatal Supplements Strike Out Again”.

[Note: It sometime takes a while for supplement labels to be posted in the NIH Dietary Supplement Label Database. The authors acknowledged that this study may not include supplements introduced or reformulated in the last quarter of 2022.]

Is It Three Strikes And You Are Out? 

pregnant women taking vitaminsIf you are pregnant or thinking of becoming pregnant, this should be a wake-up call.

70% of pregnant women in this country take prenatal supplements, usually based on recommendations by their health care provider. They assume the prenatal supplements meet their needs and the needs of their unborn baby.

Yet three studies evaluating the adequacy of prenatal supplements have been published in the past few months. They took very different approaches in evaluating the supplements. But all three studies concluded that the vast majority of prenatal supplements on the market are woefully inadequate.

You may be wondering, “Is it three strikes, and you are out?” Are there no decent prenatal supplements on the market?  The answer to those questions is, “No. There are good prenatal supplements on the market.”

You may be wondering how I can say that in the face of such overwhelming negative data. That’s because while all 3 studies were very good studies, they each had “blind spots”:

1) Each of the studies used very stringent criteria for identifying adequate prenatal supplements. In some cases, their criteria were stricter than the RDA recommendations and the recommendations of the American College of Obstetrics and Gynecology for pregnant and lactating women. It could be argued that their criteria were too stringent.

2) In the case of the current study, it could also be argued that evaluating only 6 nutrients is not a good criterion for evaluating the adequacy of prenatal supplements. For example, I looked up the one supplement rated as adequate in this study. It does provide appropriate doses of the 6 nutrients this study focused on. It also provides appropriate doses of vitamin K and iodine. But it does not provide choline. It is a very good supplement for women, but it is not the perfect prenatal supplement.

So, what can you do? How can you find the best prenatal supplement for you? Unfortunately, you cannot rely on advice from your friends or your health professional. You cannot rely on advertisements. That is a good place to start, but you have to do your own sleuthing.

With that in mind, I have listed 7 simple rules for selecting the best possible prenatal supplement in  my article about the first two studies. Use these rules for evaluating every prenatal supplement you come across. Happy sleuthing.

The Bottom Line 

A recent study evaluated all 20,547 supplements on the US market to see if they met the needs of pregnant women in this country.

  • They focused on 6 nutrients (vitamin A, vitamin D, folic acid, calcium, iron, and omega-3s) known to be essential for a healthy pregnancy.
  • They determined the dietary intake for all 6 nutrients in a cross section of pregnant women in the US.
  • They added the amount of the 6 nutrients in each of the 20,547 supplements to the dietary intake of those nutrients by pregnant women.
  • They then asked which supplements provided the “appropriate dose” of all 6 nutrients. They defined “appropriate dose” as the dose range that was.
    • High enough to prevent deficiency of that nutrient in 90% of pregnant women taking the supplement…and…
    • Low enough to prevent toxicity from that nutrient in 90% of pregnant women taking the supplement.
  • In other words, for each of the 6 nutrients they calculated a supplemental dose range that was neither too low nor too high.

Of the 20,547 supplements (421 labeled as prenatal supplements) available on the US market:

  • Only 69 (0.3%) supplements contained all 6 nutrients they considered essential for a healthy pregnancy.
  • Only 1 supplement contained all 6 nutrients at the appropriate doses, and it wasn’t even labeled as a prenatal supplement.

The authors concluded, “Almost no US dietary supplements provide key nutrients in the doses needed for pregnant women. Affordable and convenient products that fill the gap between food-based intake and estimated requirements of pregnancy without inducing excess intake are needed to support pregnant women and their offspring.”

[Note: It sometime takes a while for supplement labels to be posted in the NIH Dietary Supplement Label Database. The authors acknowledged that this study may not include supplements introduced or reformulated in the last quarter of 2022 or early 2023.]

If you are pregnant or thinking of becoming pregnant, this should be a wake-up call.

70% of pregnant women in this country take prenatal supplements, usually based on recommendations by their health care provider. They assume the prenatal supplements meet their needs and the needs of their unborn baby.

Yet three studies evaluating the adequacy of prenatal supplements have been published in the past few months. And all three studies concluded that the vast majority of prenatal supplements on the market are woefully inadequate.

You may be wondering, “Is it three strikes, and you are out?” Are there no decent prenatal supplements on the market?  The answer to those questions is, “No. There are good prenatal supplements on the market.”

You may be wondering how I can say that in the face of such overwhelming negative data. That’s because while all 3 studies were very good studies, they each had “blind spots”:

For more details on this study and 7 tips on finding the best prenatal supplement 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

 

 

Health Tips From The Professor