Currently browsing posts about: Conflicts-of-interest

The Study:  Maaike J. Bruins and Ulla Létinois. Adequate Vitamin D Intake Cannot Be Achieved within Carbon Emission Limits Unless Food Is Fortified: A Simulation Study.  Nutrients 2021, 13(2), 592; https://doi.org/10.3390/nu13020592

Conclusion: The present study shows that adequate intakes for vitamin D cannot be achieved with the current diet alone within realistic calorie and carbon emission limits, and additional vitamin D sources are needed to overcome the shortfalls. Universal fortification along with small dietary shifts represents an approach to improve the vitamin D status of the general population, at a high acceptability without affecting the carbon footprint.

Conflicts of Interest: M.J.B. and U.L. are employed by DSM Nutritional Products, a manufacturer of nutritional ingredients.

Comment: Study after study shows that vitamin D supplements do not make healthy people healthier, but the idea persists and supplement companies take advantage of faith in these products.  Well, there isn’t much evidence for harm either, but sunshine on skin is a better source by far.

OK.  I know there’s a big controversy about this.

Here’s a study that shows benefits for patients with COVID; supplements were associated with keeping people out of intensive care.  One of its authors has financial ties to supplement companies, but the study has been criticized on other grounds as has a member of the British Parliament who thinks it provides evidence for supplementing everyone.

And here’s an independently funded study in JAMA shows that vitamin D to have no effect on patients hospitalized with Covid-19.

This one, comes with an editorial.

Given the lack of highly effective therapies against COVID-19, except perhaps for corticosteroids, it is important to remain open-minded to emerging results from rigorously conducted studies of vitamin D (despite smaller sample sizes and important limitations of some studies). However, taken together with existing randomized clinical trials of vitamin D administration in hospitalized patients with respiratory infection and critical illness, the results reported by Murai et al¹² do not support routine administration of vitamin D in hospitalized patients with moderate to severe COVID-19.

Fortunately, vitamin D supplements are unlikely to be harmful unless taken in very large doses.

Sunshine, anyone?

As a general rule, industry-funded studies produce results favorable to the sponsor’s interests.  But what have we here?

The study: A Systematic Review and Meta-Analysis of Randomized Controlled Trials on the Effects of Oats and Oat Processing on Postprandial Blood Glucose and Insulin Responses.  Kathy Musa-Veloso, Daniel Noori, Carolina Venditti, Theresa Poon, Jodee Johnson, Laura S Harkness, Marianne O’Shea, YiFang Chu.  The Journal of Nutrition, Volume 151, Issue 2, February 2021, Pages 341–351.

Results: the consumption of thick—but not thin—oat flakes was associated with significant reductions in postprandial blood glucose and insulin responses.

Conclusion: “Relative to a refined grain control food with the same amount of available carbohydrate, the postprandial glycemic and insulin responses elicited by intact oat kernels and thick oats were significantly reduced. The postprandial glycemic and insulin responses with thin/instant/quick oats were not significantly different from those elicited by the refined grain control.”

Funding: The systematic review and meta-analysis, as well as the writing of the manuscript, were funded by PepsiCo, Inc.

Author disclosures: “KM-V, DN, CV, and TP are employees of Intertek Health Sciences Inc., which has provided consulting services to PepsiCo, Inc. JJ, MO, and YC are employees of PepsiCo, Inc., which manufactures oatmeal products under the brand name Quaker Oats and which funded this systematic review and meta-analysis. LSH is a former employee of PepsiCo, Inc.  The views expressed in this article are those of the authors and do not necessarily reflect the opinion or policies of Intertek Health Sciences Inc. or PepsiCo, Inc.”

Comment:  This is a PepsiCo study paid for by the company and conducted by employees or contractors.  PepsiCo owns Quaker Oats instant oatmeal.  In the late 1980s, oat bran was a craze.  Everyone I knew was sprinkling oat bran on everything they ate as a means to reduce their blood cholesterol levels.  Even then, there were real questions about whether oats had any special effects on blood cholesterol levels.   But the idea has persisted.  This study demonstrates that oats might have metabolic benefits, but only if they are thick, whole-grain, and minimally processed.  Instant oatmeal is not in that category.  I wonder what the company’s reaction is to this study, whether it intends to fund more like it, and whether it will us thicker oats in its Quaker products.

I’ve been collecting items about meat.  This is a good week to post them, starting with this.

The study:  Effects of Total Red Meat Intake on Glycemic Control and Inflammatory Biomarkers: A Meta-Analysis of Randomized Controlled Trials. Lauren E O’Connor, Jung Eun Kim, Caroline M Clark, Wenbin Zhu, and Wayne W Campbell. . Adv Nutr 2021;12:115–127.

Conclusion:  “Total red meat consumption, for up to 16 weeks, does not affect changes in biomarkers of glycemic control or inflammation for adults free of, but at risk for, cardiometabolic disease.”

Funder (my emphasis): “This study was funded by The Pork Checkoff and Purdue University’s Bilsland Dissertation Fellowship (LEO). The funder had no role in the design or conduct of the study or the analysis or interpretation of data.

Author disclosures: LEO received honoraria and travel to present related research as a graduate student from the National Cattlemen’s Beef Association. During the time this research was conducted, WWC received funding for research grants, travel, or honoraria for scientific presentations or consulting services from the following organizations: National Cattlemen’s Beef Association, National Pork Board, National Dairy Council, North Dakota Beef Commission, Foundation for Meat and Poultry Research and Education, Barilla Group, New York Beef Council, and North American Meat Institute. All the other authors report no conflicts of interest.

Comment:  Red meat is under attack for its strong association with health problems, cancer in particular.  In the 24 studies this group looked at, selected out of nearly 1200, they found no bad effects.  This is a typical result for an industry-funded study conducted by investigators with industry ties.  It would be more reassuring if found by independent investigators.

The study: Effects of Unsweetened Preloads and Preloads Sweetened with Caloric or Low-/No-Calorie [LNCS] Sweeteners on Subsequent Energy Intakes: A Systematic Review and Meta-Analysis of Controlled Human Intervention Studies.  Han Youl Lee, Maia Jack, Theresa Poon, Daniel Noori, Carolina Venditti, Samer Hamamji, Kathy Musa-Veloso.  Advances in Nutrition, nmaa157, https://doi.org/10.1093/advances/nmaa157

Conclusions:  “These findings suggest that LNCS-sweetened foods and beverages are viable alternatives to CS-sweetened foods and beverages to manage short-term energy intake.

Funder: The American Beverage Association provided funding for the work presented herein.

Author disclosures: MJ is a paid employee of the American Beverage Association. Intertek Health Sciences, Inc.(HYL, TP, DN, CV, SH, KMV), works for the American Beverage Association as paid scientific and regulatory consultants.

Comment: This is a study paid for by the American Beverage Association, a trade association for the makers of soft drinks, sweetened with sugars or artificial sweeteners, conducted in-house.  Its purpose is to demonstrate that artificial and low-calorie sweeteners will help you lose weight, something that independently funded studies often do not.  I’d classsify this as marketing research.  I don’t think it belongs in professional journals published by the American Society for Nutrition.  We need a new journal for this, as Corinna Hawkes of City University London once suggested, “The Journal of Industry-Funded Research.”

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.

I learned about this one from a press release: “Can eating mangoes reduce women’s facial wrinkles?”

A new study from researchers at the University of California, Davis, finds eating Ataulfo mangoes, also known as honey or Champagne mangoes, may have another benefit — reducing facial wrinkles in older women with fairer skin. The study was published in the journal Nutrients.

Postmenopausal women who ate a half cup of Ataulfo mangoes four times a week saw a 23 percent decrease in deep wrinkles after two months and a 20 percent decrease after four months.

Surely, this can’t be serious?  Who paid for this?

The study: Prospective Evaluation of Mango Fruit Intake on Facial Wrinkles and Erythema in Postmenopausal Women: A Randomized Clinical Pilot Study.  Vivien W. Fam, Roberta R. Holt Carl L. Keen, Raja K. Sivamani .  and Robert M. Hackman.  Nutrients 2020, 12(11), 3381; https://doi.org/10.3390/nu12113381

Method: Women were given either 85 g or 250 g of mangos to eat every day for 16 weeks.  Their wrinkles were photographed and measured before and after.

Conclusion: “The intake of 85 g of mangos reduced wrinkles in fair-skinned postmenopausal women, while an intake of 250 g showed the opposite effect.”

Funding: “This study was supported in part by a grant from the National Mango Board (NMB)…which also supplied the fresh mangos for the study. The NMB had no role in the study design, data collection, data analysis, manuscript preparation, or publication decision.”

Conflicts of Interest: The authors declare no conflict of interest.

Comment:  I love mangos (despite being somewhat allergic to them), but come on.  According to the press release, the researchers “said it’s unclear why consuming more mango would increase the severity of wrinkles but speculate that it may be related to a robust amount of sugar in the larger portion of mangoes.”  Another interpretation is that mangos have no effect (which makes more sense).  In any case, this study did not compare mangos to any other fruit.  This is a classic case of an industry-sponsored study coming out with results favorable to the sponsor’s interests and allowing those interests to be announced in a press release.  The authors may think industry sponsorship does not create a conflict of interest, but much evidence strongly suggests that it does (I reviewed that evidence in my book, Unsavory Truth).

Even after writing Unsavory Truth: How the Food Industry Skews the Science of What We Eat I could hardly believe this particular example.

The Study: Exploring the Influence of Alcohol Industry Funding in Observational Studies on Moderate Alcohol Consumption and Health.   Moniek Vos, Annick P M van Soest, Tim van Wingerden, Marion L Janse, Rick M Dijk, Rutger J Brouwer, Iris de Koning, Edith J M Feskens, Aafje Sierksma.  Advances in Nutrition, Volume 11, Issue 5, September 2020, Pages 1384–1391.

Methods:  This is a meta-analysis of meta-analyses of studies examining the health effects of alcohol consumption that are used as the basis of international guidelines for alcohol consumption.

Results and conclusions: “only a small proportion of observational studies in meta-analyses …are funded by the alcohol industry. Based on this selection of observational studies the association between moderate alcohol consumption and different health outcomes does not seem to be related to funding source.

Funding: “The authors reported no funding received for this study.”

Author disclosures: “MV, APMvS, TvW, MLJ, RMD, RJB, IdK, and AS were employed by the Dutch Beer Institute during the study and writing of the manuscript. This Institute is funded by Dutch Brewers, which is the trade organization of the 14 largest beer brewers in the Netherlands. EJMF reports no conflicts of interest.”

Comment: This one defies credulity: an industry-funded study—most authors work for the beer industry—of whether industry funding affects research outcome.

Guess what?  It didn’t find any effect.

For years, the alcohol industry has been working hard to convince regulators and the public that moderate drinking, especially of wine and beer, is not only harmless but actually improves health.  This study is an example of how this industry attempts to accomplish that goal.

For another egregious example, see this post.

When I saw the title of this study, I had two questions:

• Why would anyone do a study like this? (OK, in short-term studies, consuming water or soup before meals reduces immediate calorie consumption, but in the long term?)
• Who paid for it?  (Getting the answer to this one took some digging).

The study: Association between soup consumption and obesity: A systematic review with meta-analysis. M.Kuroda and K. Ninomiya. Physiology & Behavior,  Volume 225, 15 October 2020, 113103.

Conclusion: “soup consumption is significantly related to lower odds ratio of obesity…suggesting that soup consumption was inversely correlated with a risk of obesity.”