Currently browsing posts about: Sponsored-research

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.

A low-fat spread with added plant sterols and fish omega-3 fatty acids lowers serum triglyceride and LDL-cholesterol concentrations in individuals with modest hypercholesterolaemia and hypertriglyceridaemia.  Blom AM, et al.  European Journal of Nutrition.  2019;58(4):1615–1624.

Purpose: “to investigate the triglyceride (TG) and LDL-cholesterol (LDL-C) lowering effects of a spread [i.e., margarine] with added plant sterols (PS) and fish oil as compared to a placebo spread.”

Conclusions: “Four-week consumption of the intervention spread led to significant and clinically relevant decreases in serum TG, LDL-C and other blood lipid concentrations.”

Funder: The study was funded by Unilever BCS Research and Development Vlaardingen, the Netherlands.

Conflicts of interest: of the authors, four are employed by Unilever.

Comment: Unilever makes margarines with plant sterols and fish oils.  You might buy them if they control blood lipid risk factors for heart disease.  This is in-house company research aimed at proving the benefits of a Unilever product, which is what so many other companies do.

But Unilever was one of the few Big Food companies that sponsored basic research (and maybe it still does?).  As I describe in my book, Unsavory Truth, Unilever was the sponsor of the basic research that demonstrated the harmful effects of trans-fat on disease risk.

I spotted some tweets about this study from Washington Post writer Tamar Haspel, who has a sharp eye for this sort of thing.  Her first tweet said:

Her second tweet explained the problem:

So of course I had to look up the study.  It’s not one I would ordinarily have noticed because its title does not use the word “probiotic,” which typically refers to the live bacteria (in yogurt, for example).  The evidence for benefits of probiotics is iffy, so this study raises lots of questions.

Let’s take a look at it:

The Study:  Supplementation with Akkermansia muciniphila in overweight and obese human volunteers: a proof-of-concept exploratory study. Depommier C, et al.  Nature Medicine (2019) Letter | Published: 01 July 2019.

Conclusion: I’ve left out the statistics to make this easier to read:  “Compared to placebo, pasteurized A. muciniphila improved insulin sensitivity…, and reduced insulinemia…and plasma total cholesterol…. Pasteurized A. muciniphila supplementation slightly decreased body weight…compared to the placebo group, and fat mass…and hip circumference…compared to baseline….In conclusion, this proof-of-concept study…shows that the intervention was safe and well tolerated and that supplementation with A. muciniphila improves several metabolic parameters.”

Competing interests:  Five of the authors “are inventors of patent applications…filed with [patent offices in at least 12 countries]…dealing with the use of A. muciniphila and its components in the context of obesity and related disorders.” Two of the authors are cofounders of A-Mansia Biotech S.A., a Belgian company that sells A. muciniphila supplements, presumably as weight-loss supplements.

Comment: As Haspel points out, the subjects in this study were given either (a) live bacteria, (b) Pasteurized (and, therefore, mostly dead) bacteria, or (c) a placebo.  The Pasteurized ones were associated with metabolic benefits and weight loss.  Pasteurization is what gets done to milk to kill most—not all—of the living bacteria it contains.  In this study, Pasteurized bacteria had the same effect on the microbiome as the unpasteurized.  The point of the study was to show that the Pasteurized supplement would induce weight loss; the observed loss, however, was not statistically significant.   Nature Medicine‘s editors should know better.  So should the New York Times’ editors.  Haspel points out that the New York Times account of the study accepted its conclusion uncritically, headlining it “A Probiotic for Obesity?”  At least the headline included a question mark.  The article did not mention the authors’ patents or conflicts of interest; it should have.

Bottom line: If you want to keep your microbiome healthy, eat a healthy diet.