by Marion Nestle

Currently browsing posts about: Supplements

Jan 25 2021

Conflicts of interest in nutrition research: this week’s example

Selenium, antioxidants, cardiovascular disease, and all-cause mortality: a systematic review and meta-analysis of randomized controlled trials. David JA Jenkins, David Kitts, Edward L Giovannucci, Sandhya Sahye-Pudaruth, Melanie Paquette, Sonia Blanco Mejia, Darshna Patel, Meaghan Kavanagh, Tom Tsirakis, Cyril WC Kendall, Sathish C Pichika, and John L Sievenpiper.  The American Journal of Clinical Nutrition, Volume 112, Issue 6, December 2020, Pages 1642–1652

Background: “Antioxidants have been promoted for cardiovascular disease (CVD) risk reduction and for the prevention of cancer. Our preliminary analysis suggested that only when selenium was present were antioxidant mixtures associated with reduced all-cause mortality.”

Results: No association of selenium alone or antioxidants was seen with CVD and all-cause mortality. However, a decreased risk with antioxidant mixtures was seen for CVD and all-cause mortality when selenium was part of the mix.

Conclusion: The addition of selenium should be considered for supplements containing antioxidant mixtures if they are to be associated with CVD and all-cause mortality risk reduction.

Comment: The results are statistically significant, but not by much (RR: 0.90; 95% CI: 0.82, 0.98; P = 0.02); the Confidence Interval reaches 0.98, which is very close to 1.00, which would show no difference.  But that’s not the real reason for my interest in this one.  The real reason in this astounding conflicts-of-interest statement and the disclaimer that follows it.

Conflicts of interest

DJAJ has received research grants from Loblaw Companies Ltd, the Almond Board of California, Soy Nutrition Institute (SNI), and the Canadian Institutes of Health Research (CIHR). He has received in-kind supplies for trials as a research support from the Almond Board of California, Walnut Council of California, American Peanut Council, Barilla, Unilever, Unico, Primo, Loblaw Companies, Quaker (Pepsico), Pristine Gourmet, Bunge Limited, Kellogg Canada, and WhiteWave Foods. He has been on the speakers’ panel, served on the scientific advisory board, and/or received travel support and/or honoraria from the Loblaw Companies Ltd, Diet Quality Photo Navigation (DQPN), Better Therapeutics (FareWell), Verywell, True Health Initiative (THI), Heali AI Corp, Institute of Food Technologists (IFT), Soy Nutrition Institure (SNI), Herbalife Nutrition Institute (HNI), Herbalife International, Pacific Health Laboratories, Nutritional Fundamentals for Health (NFH), the Soy Foods Association of North America, the Nutrition Foundation of Italy (NFI), the Toronto Knowledge Translation Group (St. Michael’s Hospital), the Canadian College of Naturopathic Medicine, The Hospital for Sick Children, the Canadian Nutrition Society (CNS), and the American Society of Nutrition (ASN). He received an honorarium from the USDA to present the 2013 W. O. Atwater Memorial Lecture. He is a member of the International Carbohydrate Quality Consortium (ICQC). His wife, Alexandra L Jenkins, is a director and partner of INQUIS Clinical Research for the Food Industry; his 2 daughters, Wendy Jenkins and Amy Jenkins, have published a vegetarian book that promotes the use of the plant foods advocated here, The Portfolio Diet for Cardiovascular Risk Reduction; and his sister, Caroline Brydson, received funding through a grant from the St. Michael’s Hospital Foundation to develop a cookbook for one of his studies. CWCK has received grants or research support from the Advanced Food Materials Network, Agriculture and Agri-Foods Canada (AAFC), Almond Board of California, American Peanut Council, Barilla, Canadian Institutes of Health Research (CIHR), Canola Council of Canada, International Nut and Dried Fruit Council, International Tree Nut Council Research and Education Foundation, Loblaw Brands Ltd, Pulse Canada, and Unilever. He has received in-kind research support from the Almond Board of California, American Peanut Council, Barilla, California Walnut Commission, Kellogg Canada, Loblaw Companies, Quaker (PepsiCo), Primo, Unico, Unilever, and WhiteWave Foods/Danone. He has received travel support and/or honoraria from the American Peanut Council, Barilla, California Walnut Commission, Canola Council of Canada, General Mills, International Nut and Dried Fruit Council, International Pasta Organization, Loblaw Brands Ltd, Nutrition Foundation of Italy, Oldways Preservation Trust, Paramount Farms, Peanut Institute, Pulse Canada, Sun-Maid, Tate & Lyle, Unilever, and White Wave Foods/Danone. He has served on the scientific advisory board for the International Tree Nut Council, International Pasta Organization, McCormick Science Institute, and Oldways Preservation Trust. He is a member of the International Carbohydrate Quality Consortium (ICQC), is Executive Board Member of the Diabetes and Nutrition Study Group (DNSG) of the European Association for the Study of Diabetes (EASD), is on the Clinical Practice Guidelines Expert Committee for Nutrition Therapy of the EASD and a director of the Toronto 3D Knowledge Synthesis and Clinical Trials foundation. JLS has received research support from the Canadian Foundation for Innovation, Ontario Research Fund, Province of Ontario Ministry of Research and Innovation and Science, Canadian Institutes of Health Research (CIHR), Diabetes Canada, PSI Foundation, Banting and Best Diabetes Centre (BBDC), American Society for Nutrition (ASN), INC International Nut and Dried Fruit Council Foundation, National Dried Fruit Trade Association, The Tate and Lyle Nutritional Research Fund at the University of Toronto, The Glycemic Control and Cardiovascular Disease in Type 2 Diabetes Fund at the University of Toronto (a fund established by the Alberta Pulse Growers), and the Nutrition Trialists Fund at the University of Toronto (a fund established by an inaugural donation from the Calorie Control Council). He has received in-kind food donations to support a randomized controlled trial from the Almond Board of California, California Walnut Commission, American Peanut Council, Barilla, Unilever, Upfield, Unico/Primo, Loblaw Companies, Quaker, Kellogg Canada, WhiteWave Foods, and Nutrartis. He has received travel support, speaker fees, and/or honoraria from Diabetes Canada, Dairy Farmers of Canada, FoodMinds LLC, International Sweeteners Association, Nestlé, Pulse Canada, Canadian Society for Endocrinology and Metabolism (CSEM), GI Foundation, Abbott, Biofortis, ASN, Northern Ontario School of Medicine, INC Nutrition Research & Education Foundation, European Food Safety Authority (EFSA), Comité Européen des Fabricants de Sucre (CEFS), and Physicians Committee for Responsible Medicine. He has or has had ad hoc consulting arrangements with Perkins Coie LLP, Tate & Lyle, Wirtschaftliche Vereinigung Zucker e.V., and Inquis Clinical Research. He is a member of the European Fruit Juice Association Scientific Expert Panel and Soy Nutrition Institute (SNI) Scientific Advisory Committee. He is on the Clinical Practice Guidelines Expert Committees of Diabetes Canada, European Association for the Study of Diabetes (EASD), Canadian Cardiovascular Society (CCS), and Obesity Canada. He serves or has served as an unpaid scientific advisor for the Food, Nutrition, and Safety Program (FNSP) and the Technical Committee on Carbohydrates of the International Life Science Institute (ILSI) North America. He is a member of the International Carbohydrate Quality Consortium (ICQC), executive board member of the Diabetes and Nutrition Study Group (DNSG) of the EASD, and director of the Toronto 3D Knowledge Synthesis and Clinical Trials foundation. His wife is an employee of AB InBev. DK, ELG, SS-P, MP, SBM, DP, MK, TT, and SCP have no conflicts of interest to declare.

Disclaimer: The authors have no relevant conflicts of interest over the past 4 y. DJAJ has received funds for dietary studies from Loblaws, which, during the course of his funding, acquired Shopper’s Drugmart, which is a pharmaceutical company that also sells supplements.

Comment: Here’s one reason why I am not a fan of dietary supplements.  Most independently funded studies show no significant benefit when they are given to healthy people.  The industry needs studies like these for marketing purposes.  I’m not, but if you are worried about selenium, try food.

Jan 21 2021

Vitamin D and coronavirus: more on the ongoing saga

Vitamin D is such a hot topic for its purported role in preventing or treating coronavirus infections that I seem to have written about it four previous times.  These are here, here, here, and here.

Now, a group of 120 scientists has called on world governments to get their populations to increases vitamin D consumption to 2000 to 4000 units per day, five to ten times higher than current recommendations.  Their letter is here.

This is especially interesting because nutrition and health societies in the UK  advise quite the opposite: no change in the usual recommendation for vitamin D intake (400 units/day).  Their report says (my emphasis):

  • Do not offer a vitamin D supplement to people solely to prevent COVID-19, except as part of a clinical trial.
  • Do not offer a vitamin D supplement to people solely to treat COVID-19, except as part of a clinical trial.

I’m always interested to see what ConscienHealth has to say about such things.

The passion of the vitamin D fan club is striking. However, neither passion nor speculation should be a substitute for facts. Right now, the facts tell us that the reason to take a vitamin D supplement is to protect our muscles and bones. Any thought that it will help with COVID-19 is speculation, and taking too much would be quite unwise.

My sentiments precisely.

Dec 24 2020

Using the pandemic as a business opportunity, European version

Food Safety News reports that the European Commission is getting increasingly upset about fraudulent claims that specific food and supplement products will boost immunity and help protect against Covid-19 or even cure it.

Alas, they will not.

The EC is worried about online advertisements.  Food Safety News reported more than 350 cases of such claims in June.  Now there are even more.

In the US, we mostly see this sort of thing—websites from the supplement industry telling you to take supplements.  Here  is what this one claims, with my comments in red.

Supplements can help you address nutrient insufficiencies or deficiencies in your diet—but can they help you fight COVID-19? Not as far as anyone knows.

While there hasn’t been specifically-targeted research to determine which—if any—nutrients should be FDA-approved to ward off the virus, [Indeed] supplements are an ideal way to keep your body and your immune system functioning at optimal levels. No, they are not.  Food works much better.

As a result, many physicians and other health and wellness experts recommend beginning a simple supplement routine to ensure your body has the nutrients it needs to stay healthy.  Many others do not, and neither do I.…The supplements you take during the COVID-19 pandemic may not be specifically developed to ward off the coronavirus. Right.  So don’t expect them to work.

Still, research has shown that they all play an important role in boosting the immune system, preventing respiratory damage, strengthening the body against viral infections, reducing inflammation—or all of the above.  This is true, but largely in experimental studies likely to have been funded by the supplement industry.

Obviously, I am not a fan of supplements.  There just isn’t much evidence that they do anything useful for healthy people, and healthy people are the ones most likely to be taking them.

With respect to Covid-19, the best preventive strategy is avoidance (masks, distancing, etc).

The best immune-boosting strategy is to eat a healthy diet–largely (but not necessarily exclusively) plant-based, balanced in calories, and with minimal amounts of ultra-processed junk foods.

And let’s all hope the vaccination comes soon and works like a charm.

Happy holidays.

Dec 10 2020

Some odd items, just for fun

I’ve been collecting intriguing items about new foods and supplements, soon to be at a supermarket near you.

Nov 30 2020

Industry-funded nutrition-and-Covid advice: take our supplements!

I’m always interested in how food, beverage, and supplement companies are taking advantage of fears of Covid-19 to sell their products.

The supplement company. Nutricia, has produced a report, Learnings from a Global Pandemic: The Role of Nutrition in COVID-19 Recovery and the Ongoing Pursuit of Healthy Aging 

The logic of this report goes:

  • Covid-19 disproportionally affects older adults.
  • Healthy immune systems help prevent bad outcomes.
  • Nutrition is important for a healthy immune system.

No argument there.  At issue is how to have a healthy immune system.

A wealth of mechanistic and clinical data21 show that beyond protein and energy, vitamins (including A, B6, B12, C, D, E, and folate) and trace elements (zinc, iron, selenium, magnesium, and copper) and omega-3 fatty acids (eicosapentaenoic acid and docosahexaenoic acid) play important and complementary roles in supporting the immune system. Inadequate intake of these nutrients can lead to a decrease in resistance to infections and as a consequence an increase in disease burden.

Therefore, the question is how to get these nutrients.  I vote for food.  Nutricia, no surprise, has another suggestion, especially for hospitalized patients:

Treatment should continue after hospital discharge with ONS [oral nutritional supplements] and individualized nutritional plans.

Nutricia is owned by Danone.  Danone announced this week that  it is cutting 2000 jobs to save more than a billion dollars.

As the pandemic continues to surge, the yogurt and beverage giant has been impacted by the closure of restaurants and other venues that reduced demand for its water, a reduction of SKUs [stock keeping units] offered by its retail partners and a drop in the number of births that has curtailed consumption of its baby formula products.

One solution: sell more supplements, and use Covid-19 to do so.

Will supplements protect against catching Covid-19 or experiencing its worst symptoms?  I’m waiting for the data.

I still think it’s healthier to get nutrients from foods.

Sep 28 2020

Industry-sponsored studies of the week: two on omega-3 supplements

I.  Expert Opinion on Benefits of Long-Chain Omega-3 Fatty Acids (DHA and EPA) in Aging and Clinical Nutrition, Troesch B, et al.  Nutrients 2020;12(9):2555.

Conclusion: The evidence to date indicates that the provision of DHA and EPA through capsules, oral nutrition supplements, or enteral or parenteral formulas can help to regulate the inflammatory environment in a number of medical conditions and that this is linked in many cases to improved function, clinical course and outcomes.

Funding: DSM Nutritional Products Ltd. provided financial support to organize and invite experts to participate as discussants, based on their expertise on the role of DHA and EPA in aging as well as different medical conditions, as well as financial support for the development of this review.
Conflicts of Interest: B.T. and I.W. are employed by DSM Nutritional Products Ltd.; M.E. acts as an advisor for DSM, received travel reimbursement from DSM and is a member of the Scientific Board of PM International and President of the Gesellschaft für angewandte Vitaminforschung; A.L. received consulting fees from BBraun, DSM, Nutricia and Smartfish and received honoraria for independent lectures from Abbott, Baxter, BBraun, Fresenius Kabi, Nestlé Health Science, Nutricia and Smartfish; Y.R. received travel reimbursement from DSM; AW receives speaker fees from Baxter Germany, Berlin Chemie, BBraun Melsungen AG, DSM, Ethicon, Falk Foundation Fresenius Kabi Deutschland GmbH, Medtronic and research grants from Baxter, Danone and Mucos; P.C.C. acts as a consultant for DSM, BASF, Danone/Nutricia, Cargill, Smartfish and Fresenius Kabi. A.D.S. has no conflict to declare.
Comment: DSM Nutrition Products is a major seller of dietary supplements, with a highly vested interest in demonstrating the benefits of the supplements it sells.  Evidence on the benefits of omega-3 fatty acid supplements tends to vary enormously.  Some studies, like this one, find benefits.  Other studies do not (see, for example, this, this, or this).  Could funding source have something to do with these differences?  I think yes.  
Before I had a chance to post this one, a reader, Dr. Eliška Selinger, who teaches science methods and nutrition in Prague, sent yet another example, this one not yet published.II.  Effect of Omega-3 Dosage on Cardiovascular Outcomes: An Updated Meta-Analysis and Meta-Regression of Interventional Trials. Aldo A. Bernasconi, PhD; Michelle M. Wiest, PhD; Carl J. Lavie, MD; Richard V. Milani, MD; and Jari A. Laukkanen, MD, PhD.  Article in press Mayo Clin Proc. n XXX 2020;nn(n):1-10 n https://doi.org/10.1016/j.mayocp.2020.08.034

Objectives: “To quantify the effect of eicosapentaenoic (EPA) and docosahexaenoic (DHA) acids on cardiovascular disease (CVD) prevention and the effect of dosage.”

Conclusion: “Cardiovascular disease remains the leading cause of death worldwide. Supplementation with EPA and DHA is an effective lifestyle strategy for CVD prevention, and the protective effect probably increases with dosage.”

Potential Competing Interests: “Dr Bernasconi is an employee of the Global Organization for EPA and DHA Omega-3s (GOED), a 501(c)6 not-for profit trade association. GOED’s goals are to increase consumption of omega3s to adequate levels around the world and to ensure that the industry is producing quality omega-3 products that consumers can trust. Dr Wiest has been a guest speaker with travel sponsored by DSM Nutritional Products and the Global Organization for EPA and DHA Omega-3s (GOED); and has received funding from GOED to conduct a meta-analysis on omega-3 fatty acids. Dr Lavie has been a speaker for Amarin Corporation on Vascepa, has consulted for DSM Nutritional Products, and has made an omega-3 educational video at the American Heart Association meeting on November 14, 2016, for the Global Organization for EPA and DHA Omega-3s and also gave a presentation at a GOED-hosted omega-3 conference in Barcelona, Spain, in February 2020. The remaining authors report no potential competing interests.”

Grant Support: “This study was supported by a grant from the Global Organization for EPA and DHA Omega-3s (GOED), Salt Lake City, UT.”

Comment: The Global Organization for EPA and DHA Omega-3s “represents the worldwide EPA and DHA omega-3 industry…Our mission is to increase consumption of EPA and DHA omega-3s…”   Omega-3 fatty acids are essential to human health and are widely available from green leafy vegetables (in the form of ALA) as well as from fish (EPA and DHA).   ALA is converted in the body to EPA and DHA.   The benefits of omega-3 supplements, as I just explained, are not well established.  This trade association for EPA and DHA supplements funded this study to demonstrate the benefits of these products.  Caveat emptor.

Aug 3 2020

Dubious health claim of the week: cranberries and UTIs

The FDA has just announced a Qualified Health Claim for Certain Cranberry Products and Urinary Tract Infections.

The U.S. Food and Drug Administration announced today in a letter of enforcement discretion that it does not intend to object to the use of certain qualified health claims regarding consuming certain cranberry products and a reduced risk of recurrent urinary tract infection (UTI) in healthy women.

Huh?

The FDA does not exactly approve health claims that are not backed up by scientific evidence.  It just doesn’t object to them.

This one, no surprise, comes in response to a request by Ocean Spray Cranberries, Inc, which would love to be able to market its products as helping to prevent UTIs (which lots of people believe).

Here’s what the FDA says about the science.

After reviewing the petition and other evidence related to the proposed health claim, the FDA determined that the scientific evidence supporting the claim did not meet the “significant scientific agreement” standard required for an authorized health claim.

Hence, the Qualified health claim.

If Ocean Spray wants to use the claim, it has to put atatements like these on the label:

  • For cranberry juice beverages: “Consuming one serving (8 oz) each day of a cranberry juice beverage may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that the scientific evidence supporting this claim is limited and inconsistent.”
  • For cranberry dietary supplements: “Consuming 500 mg each day of cranberry dietary supplement may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that there is limited scientific evidence supporting this claim.”

Why does Ocean Spray want this?  Because believers will ignore the FDA disclaimers.  Ocean spray says:

To that end, Ocean Spray will use its medical attributes in the place they matter most–running a campaign on the WebMD site later this year. “We’re going to be all over WebMD,” he said, noting that the connection between cranberry juice and urinary tract health is the fifth most discussed topic on the influential health site.

Qualified health claims are about marketing, not science.

But I know how you feel.  UTIs are awful.  If all it takes is cranberry juice….

Apr 16 2020

Watch out for Coronavirus frauds and unproven promises

Frauds and fraudulent information are so prevalent that the FDA says what it’s doing about them on its Coronavirus web page.

My email inbox is deluged with marketers claiming that their products boost immune systems in general, and protect against Coronavirus in particular.  Often, they cite evidence but this is highly selective and sometimes based on studies paid for by their sponsors.

The bottom line on keeping immune systems healthy?  Eat a healthful diet, don’t gain excess weight, and get plenty of physical activity.  OK, good luck doing that while you are under lockdown, but you can give it a good try.

Here are some of the items that have ended up in my inbox.

Despite FDA pronouncements, industry coalition action, the coronavirus claims warning letters keep coming:  The US Food and Drug Administration has issued an additional six warning letters in recent days on coronavirus claims. The letters coincide with an industry coalition raising a red flag on the growing flood of such claims on dietary supplement-type products….Read more

Unproven COVID-19 health claims: China’s crackdown on ads for oral sprays, probiotics and anti-hangover tea: The Chinese authorities have named and shamed a string of fake advertisement, mostly surrounding unproven COVID-19 health claims.

Consumers warned of sports nutrition products making coronavirus claimsThe European Specialist Sports Nutrition Alliance (ESSNA) has warned consumers of the increase in companies and individuals making unfounded claims in light of the current coronavirus situation….Read more

Cocoa and the coronavirus: can it boost the immune system?  Cacao beans have been consumed by humans for over 3,000 years and the ingredient is well-known for its wide range of health benefits, recent research suggests it can provide stronger protection against influenza virus infection…. Watch now [but watch critically.  If you even give this a moment’s thought….]

 

CRN UK highlights why essential nutrients have never been more essential:  The ongoing threat of coronavirus could increase the potential for deficiencies in key micronutrients supporting the immune system, according to The Council for Responsible Nutrition UK (CRN UK). Read more  [How about eating a healthy diet and getting plenty of exercise?].

Could vitamin D play a role in coronavirus resistance? Research thinks so:  Vitamin D supplements may aid in the resistance of respiratory infections such as the coronavirus or limit the severity of the illness in those infected, according to researchers. Read more.  [And what kind of research are we talking about here?  Some of it is industry-funded, as this example demonstrates (thanks to Claudia Santos for sending)].