Currently browsing posts about: Sponsored-research

The study: Controlled Feeding of an 8-d, High-Dairy Cheese Diet Prevents Sodium-Induced Endothelial Dysfunction in the Cutaneous Microcirculation of Healthy, Older Adults through Reductions in Superoxide.  Billie K Alba, Anna E Stanhewicz, Priyankar Dey, Richard S Bruno, W Larry Kenney, Lacy M Alexander.  The Journal of Nutrition, nxz205, https://doi.org/10.1093/jn/nxz205

The conclusions: “These results demonstrate that incorporating dairy cheese into a high-sodium diet preserves EDD by decreasing the concentration of superoxide radicals. Consuming sodium in cheese, rather than in nondairy sources of sodium, may be an effective strategy to reduce cardiovascular disease risk in salt-insensitive, older adults.”

The funder: “This research was supported by the National Dairy Council.”

The press headline: “Gouda news for cheese lovers: study finds blood health benefit.”  The headline is clever but screamed industry-funded.  I immediately looked up the actual study to see who had paid for it.  The story in NutraIngredients.com reads like a press release.  It did not mention the funder.  It should have.

My correspondence with the editor of NutraIngredients.com over funding disclosure is the subject of tomorrow’s post.  Stay tuned.

These three papers were part of a supplement to Advances in Nutrition published in September 2019: Supplement—6th Yogurt in Nutrition Initiative (YINI) Summit / More than the Sum of Its Parts, sponsored by Danone Institutes International. Publication costs for this supplement were defrayed in part by the payment of page charges.

I.  Introduction to the Sixth Global Summit on the Health Effects of Yogurt: Yogurt, More than the Sum of Its Parts.  Sharon M Donovan ; Olivier Goulet. Advances in Nutrition, Volume 10, Issue 5, September 2019, Pages 913S–916S.

Conclusion: “Ultimately, the inclusion of fermented dairy products in food-based dietary guidelines, not only as a dairy option, but as a significant source of viable bacteria and fermentation products, could contribute to improved public health and should be considered.”

Author disclosures: “The guest editor of the supplement has the following conflict of interest: SMD co-chairs the Yogurt in Nutrition Initiative. She received reimbursement for travel expenses and an honorarium from Danone Institutes International for chairing the Sixth International Yogurt in Nutrition Summit at the Nutrition 2018 meeting in June 2018 in Boston, MA….SMD and OG are co-chairs of the Yogurt in Nutrition Initiative. Travel expenses and an honorarium were paid to SMD and OG by Danone Institutes International for chairing the Sixth International Yogurt in Nutrition Summit at the Nutrition 2018 meeting in June 2018 in Boston, MA. OG is also the Chair of Danone Institutes International.

II.  Dairy Foods, Obesity, and Metabolic Health: The Role of the Food Matrix Compared with Single Nutrients.  Dariush Mozaffarian.  Advances in Nutrition, Volume 10, Issue 5, September 2019, Pages 917S–923S,

Conclusion: “The present evidence suggests that whole-fat dairy foods do not cause weight gain, that overall dairy consumption increases lean body mass and reduces body fat, that yogurt consumption and probiotics reduce weight gain, that fermented dairy consumption including cheese is linked to lower CVD risk, and that yogurt, cheese, and even dairy fat may protect against type 2 diabetes. Based on the current science, dairy consumption is part of a healthy diet, without strong evidence to favor reduced-fat products; while intakes of probiotic-containing unsweetened and fermented dairy products such as yogurt and cheese appear especially beneficial.”

Disclosures: “DM received an honorarium from the American Society of Nutrition for the preparation of this manuscript. A freelance science writer, Denise Webb, was supported by Danone Institute International to prepare an initial draft of this manuscript for DM based on a recording of his talk and slides at the American Society of Nutrition 2018 Congress. The final manuscript was edited in detail and approved by DM. The funders had no role in the design, analysis, interpretation, review, or final approval of the manuscript for publication…DM reports research funding from the NIH and the Gates Foundation; personal fees from GOED, Nutrition Impact, Pollock Communications, Bunge, Indigo Agriculture, Amarin, Acasti Pharma, Cleveland Clinic Foundation, and America’s Test Kitchen; scientific advisory board, Elysium Health (with stock options), Omada Health, and DayTwo; and chapter royalties from UpToDate; all outside the submitted work.”

III.  Effects of Full-Fat and Fermented Dairy Products on Cardiometabolic Disease: Food Is More Than the Sum of Its Parts.  Arne Astrup; Nina Rica Wium Geiker; Faidon Magkos.  Advances in Nutrition, Volume 10, Issue 5, September 2019, Pages 917S–923S.

Conclusion: “Although more research is warranted to adjust for possible confounding factors and to better understand the mechanisms of action of dairy products on health outcomes, it becomes increasingly clear that the recommendation to restrict dietary saturated fat to reduce risk of cardiometabolic disease is getting outdated. Therefore, the suggestion to restrict or eliminate full-fat dairy from the diet may not be the optimal strategy for reducing cardiometabolic disease risk and should be re-evaluated in light of recent evidence.”

Disclosures.  “NRWG and FM, no conflicts of interest. AA is a member of advisory boards/consultant for BioCare Copenhagen, Denmark; Dutch Beer Institute, Netherlands; Gelesis, United States; Groupe Éthique et Santé, France; McCain Foods Limited, United States; Novo Nordisk, Denmark; Pfizer, United States; Saniona, Denmark; and Weight Watchers, United States. AA has received travel grants and honoraria as a speaker for a wide range of Danish and international consortia. AA is co-owner and member of the board of the consultancy company Dentacom Aps, Denmark; cofounder and co-owner of UCPH spin-outs Mobile Fitness A/S, Flaxslim ApS, and Personalized Weight Management Research Consortium ApS (Gluco-diet.dk). He is coinventor of a number of patents owned by the University of Copenhagen, in accordance with Danish law. He is coauthor of a number of diet and cookery books, including books on personalized diet approaches. AA is not an advocate or activist for specific diets and is not strongly committed to any specific diet.”

Comment

These papers aim to dispute the idea that full-fat dairy products but have negative health effects. This is a legitimate scientific question that deserves investigation and analysis, preferably by studies funded by independent sources.  Industry-funded studies and opinion pieces are well known to produce results and conclusions favorable to the sponsor’s interest, as is the case here.

Title: Almond Consumption and Risk Factors for Cardiovascular Disease:A Systematic Review and Meta-analysis of Randomized Controlled Trials. Lee-Bravatti MA, et al.  Adv Nutr. 2019;00:1–13

Method: The authors selected studies that had compared lab values of adults who consumed almonds with those who did not.  They found significant reductions in some—but not all—CVD risk factors among the almond eaters.  The almond eaters, for example, had lower total cholesterol levels and lost weight during the trials.

Conclusion: “Almond consumption may reduce the risk of CVD by improving blood lipids and by decreasing body weight and apoB [apolipoprotein B].”

Funding: “Supported by the Almond Board of California…The funder did not have a role in the study selection, quality assessment, data synthesis, or manuscript preparation.”

Author disclosures:  GR was a consultant for Porter Novelli; EJJ received funds from the Almond Board of California for a clinical trial at the time of the study. MAL-B, JW, EEA, and LK, no conflicts of interest.

Comment: I like nuts and am especially partial to marcona almonds, but I wish the almond industry would stop trying to prove that almonds can perform health miracles. I can easily see why substituting almonds for ultraprocessed junk foods would help reduce markers of CVD risk, calories, and weight: people who eat junk food consume more calories and are more likely to be obese.  This study set a standard of 42.5 grams of almonds a day, roughly 1.5 ounces  and 200 calories.  But are almonds superior to other nuts?  The Walnut Commission would argue otherwise, as would the Pecan Growers’ Association.  The Almond Board may say it has nothing to do with the study, but it doesn’t have to.  Its funding is sufficient to exert influence even if investigators don’t realize it, as I discuss in Unsavory Truth.

Here’s another study where I guessed its funder from its title.

Everyone knows whole grains are healthy and recommended.  Why do this study?  Maybe it helps to have more evidence?

Once you know the funder, you can also guess what the study will show.

To wit:

Whole Grain Wheat Consumption Affects Postprandial Inflammatory Response in a Randomized Controlled Trial in Overweight and Obese Adults with Mild Hypercholesterolemia in the Graandioos Study.  Hoevenaars FPM, et al. The Journal of Nutrition, 2019: nxz177, https://doi.org/10.1093/jn/nxz177

Objective: “The health impact of WGW [whole grain wheat] consumption was investigated by quantification of the body’s resilience, which was defined as the ‘ability to adapt to a standardized challenge.’”

Method: “A double-blind RCT [randomized control trial] was performed with overweight and obese…men (n = 19) and postmenopausal women (n = 31) aged 45–70 y, with mildly elevated plasma total cholesterol…who were randomly assigned to either 12-wk WGW (98 g/d) or refined wheat (RW).”

Conclusion: “Twelve-week 98 g/d WGW consumption can promote liver and inflammatory resilience in overweight and obese subjects with mildly elevated plasma cholesterol.”

Funding: “Supported by the public private partnership entitled “Combining innovation with tradition: improving resilience with essential nutrients and whole wheat bread,” financed by Topsector Agri & Food (TKI-AF 12083). This project was sponsored by TNO roadmap Nutrition and Health and co-funded by Cereal Partners Worldwide, the Dutch Bakery Center, and GoodMills Innovation GmbH. The funders of the study had no role in the study design, data collection, analysis, and interpretation, nor the preparation of the manuscript.”

Comment: As I keep saying (see Unsavory Truth), funders do not have to be involved.  Their influence starts from the get-go, and usually shows up in the way the research question is asked, as seen in this example.  This study is not about finding out about how whole wheat affects health (basic science); it is about demonstrating benefits from whole wheat consumption (marketing).  I’m in favor of eating more whole wheat, rather than refined, but wish food companies selling whole grains would stay out of conflicted research.

Curcumin is a flavonoid antioxidant isolated from turmeric, the spice used in Indian curries, among other foods.

It is about as overhyped as any ingredient I have encountered lately for its “proven ability” to fight Alzheimer’s, heart disease, cancer, and anything else that ails you.  If only this could be true.  If it were, people in India who use this in their cooking would all live exceptionally long and healthy lives.

But to convince skeptics like me—and to sell curcumin supplements of course—the makers of such supplements fund studies.

I learned about this study from the industry newsletter, NutraIngredients-Latam.

It reported on a an abstract of a clinical trial of a curcumin supplement, Longvida,™ made by Verdure Sciences. 

The study:  This was a double-blind, placebo-controlled, parallel-groups clinical trial in which participants were given Longvida™ (400 mg daily containing 80 mg curcumin) or a matching placebo.

Results: After 12 weeks, the curcumin group did better on memory performance and other tests, and after 4 weeks showed less tension, anger, confusion and total mood disturbance.

Conclusions: “These results confirm that Longvida™ improves aspects of mood and working memory in a healthy older cohort. The pattern of results…may hold promise for alleviating cognitive decline in some populations.”

Funding: Surprise! “This study was funded by a grant from Verdure Sciences.”

Comment: I see three problems here with the Nutraingredients report.

(1) When funders have a vested interest in the outcome of studies, biases tend to creep in.

(2) The report is based on an abstract, not on a complete account of the trial; this makes the methods difficult to assess.

(3) The report did not mention that study was funded by a company with a vested interest in the result; it should have.

A reader, Gema Flores Monreal, who holds a doctorate in Food Science and Nutrition, pointed me to this study.  She noted that it examines the effects on blood pressure of eating 5 to 6 servings of dairy per day, twice what is typically recommended. 

it is easy to understand why a dairy company would want research like this.  People are consuming less dairy food, and the industry wants to reverse the decline.

The study:  Effect of high compared with low dairy intake on blood pressure in overweight middle-aged adults: results of a randomized crossover intervention study.  Rietsema S, and 11 other authors.  Am J Clin Nutr 2019;110:340–348.

Conclusions: “This intervention study shows that an HDD [high dairy diet] results in a reduction of both systolic and diastolic BP [blood pressure] in overweight middleaged men and women. If the results of our study are reproduced by other studies, advice for high dairy intake may be added to treatment and prevention of high BP.”

Funding: “Supported by the Public–Private Partnership Topconsortium voor Kennis en Innovatie (TKI) Agri & Food (TKI-AF-12104).”  FrieslandCampina, a Dutch multinational dairy cooperative, is part of the partnership.  Two of the authors are employed by FrieslandCampina.

Comment: As I discuss in Unsavory Truth, research like this has a high probability of producing biased results.  I’m reserving judgment about dairy foods and blood pressure until results like these are confirmed by independent research.

Effect of Montmorency tart cherry juice on cognitive performance in older adults: a randomized controlled trial, Sheau C. Chai,, et al. Food Funct., 2019,10, 4423-4431.

Method: In this randomized controlled trial, 37 adults between the ages of 65–80 with normal cognitive function were recruited and randomly assigned to consume two cups of Montmorency tart cherry juice for 12 weeks.

Results: The within-group analysis showed that the visual sustained attention (p < 0.0001) and spatial working memory (p = 0.06) improved after the 12-week consumption of tart cherry juice compared with corresponding baseline values. Daily tart cherry juice consumption may improve cognitive abilities.

Conclusion: Our study demonstrated that daily intake of Montmorency tart cherry juice may help improve subjective memory and cognitive abilities in older adults as evidenced by increased contentment with memory, improved visual sustained attention and spatial working memory, and reduced movement time and total errors made on new learning tasks in older adults. T

Acknowledgements: The present study was supported by the Cherry Research Committee of the Cherry Marketing Institute, a non-profit organization. Tart cherry concentrates were provided by the Cherry Marketing Institute. Funders had no role in the study design, data collection, data analysis or interpretation, or writing of the manuscript.

Comment: I love cherries—a joy of summer—and wouldn’t it be wonderful if eating them was all you had to do to prevent cognitive decline.  Are cherries better than any other fruit or vegetable for this purpose?  This study did not examine that question but eating a healthy diet is always a good idea.  As for funders having no role, they don’t have to.  The mere fact that they funded this study skews the research question, as much evidence demonstrates (I reviewed this evidence in Unsavory Truth).

The study: Recent Research on the Health Benefits of Blueberries and Their Anthocyanins.   Wilhelmina Kalt, Aedin Cassidy, Luke R Howard, Robert Krikorian, April J Stull, Francois Tremblay,Raul Zamora-Ros.   Advances in Nutrition, nmz065, https://doi.org/10.1093/advances/nmz065

Abstract conclusion: More evidence, and particularly human clinical evidence, is needed to better understand the potential for anthocyanin-rich blueberries to benefit public health. However, it is widely agreed that the regular consumption of tasty, ripe blueberries can be unconditionally recommended.

Overall conclusion:  It can be safely stated that daily moderate intake (50 mg anthocyanins, one-third cup of blueberries) can mitigate the risk of diseases and conditions of major socioeconomic importance in the Western world.

Funding: The United States Highbush Blueberry Council (USHBC) offered support for this article by providing an honorarium to each author but had no role in the design and conduct of the review.  Author disclosures: AC, LRH, RZ-R, no conflicts of interest. AC acts as an advisor to the USHBC grant committee and has received research support from the USHBC. RK, WK, AJS, and FT have received research funding from the USHBC and have no conflict of interest.

Comment:  This is a literature review.  The USHBC paid the authors to write it.  That makes this article a paid advertisement for blueberries.  Why the authors think they have no conflict of interest in taking the money to write this is beyond me.  We can ask why the USHBC thinks this kind of “study” is needed.  Of course blueberries are recommended.  They are a fruit and all fruits are recommended.  The USHBC wants you to think that blueberries are especially beneficial, but that can be said of any fruit.  Not all fruits have sponsors paying for articles, however.

JOURNALS OF GERONTOLOGY: SPECIAL SECTION: AGING AND BLUEBERRIES (thanks to Bradley Flansbaum for sending)

The papers in this series were supported in one way or another by one or another blueberry trade associations.

• Blue Versus Gray: Potential Health Benefits of Blueberries for Successful Aging.  Donald K Ingram, PhD.  The Journals of Gerontology: Series A, Volume 74, Issue 7, July 2019, Pages 965–966. Sponsored by the Wild Blueberry Association of North America.
• Circulating Anthocyanin Metabolites Mediate Vascular Benefits of Blueberries: Insights From Randomized Controlled Trials, Metabolomics, and Nutrigenomics :  Ana Rodriguez-Mateos, et al.  The Journals of Gerontology: Series A, Volume 74, Issue 7, July 2019, Pages 967–976. This work was supported by the Medical Research Committee of the University of Düsseldorf (9772574) and by an unrestricted grant from the Wild Blueberry Association of North America. ARM and CH have received unrestricted research grants from the Wild Blueberry Association of North America. The other authors declare no conflicts of interests.
• Blueberries Improve Neuroinflammation and Cognition differentially Depending on Individual Cognitive baseline Status.  Barbara Shukitt-Hale, et al. The Journals of Gerontology: Series A, Volume 74, Issue 7, July 2019, Pages 977–983.  This research was supported by USDA Intramural funds. The blueberry powder used in this study was provided at no cost under a Material Transfer Agreement between the USDA and the U.S. Highbush Blueberry Council (USHBC). 
• Systematic Review of the Effects of Blueberry on Cognitive Performance as We Age .  Sabine Hein, et al. The Journals of Gerontology: Series A, Volume 74, Issue 7, July 2019, Pages 984–995.This work was supported by an unrestricted grant from the Wild Blueberry Association of North America.
• Polyphenols From Grape and Blueberry Improve Episodic Memory in Healthy Elderly with Lower Level of Memory Performance: A Bicentric Double-Blind, Randomized, Placebo-Controlled Clinical Study  Julien Bensalem, et al. The Journals of Gerontology: Series A, Volume 74, Issue 7, July 2019, Pages 996–1007.  This work is part of the Neurophenols project. The specific aims of the program are to characterize and formulate fruit extracts from grape and blueberry and to evaluate their safety and efficacy in pre-clinical and clinical trials. Neurophenols Industry partners, some of which sell ingredients derived from grapes and blueberries, are listed here.

Comment: The introductory paper in this series explains what it is about: “The epidemiological evidence is strong and convincing regarding the health benefits of a diet rich in fruits and vegetables to ward off age-related diseases. However, what about individual foods?”  What about them?  I love blueberries but are they really better for older adults than raspberries, strawberries, or peaches, for that matter?  Variety is still a basic principle of nutrition.  Enjoy your fruit bowl.