Currently browsing posts about: Sponsored-research

A reader, Emma Calvert, a Senior Food Policy Officerfor the European Union in Brussels, sent me “this article.  She also pointed me to the article Food Navigator wrote about it: “Review hails health benefits of beer-gut alliance.”

Eager to find out what the “beer-gut alliance” might be, I went right to it.

The study: Beer-gut microbiome alliance: a discussion of beer-mediated immunomodulation via the gut microbiome.” Silu Zhang, Shuo Jin, Cui Zhang, Shumin Hu, Huajun Li.  Front. Nutr., 25 July 2023.  Volume 10. https://doi.org/10.3389/fnut.2023.1186927

Background: “As a long-established fermented beverage, beer is rich in many essential amino acids, vitamins, trace elements, and bioactive substances that are involved in the regulation of many human physiological functions.  The polyphenols in the malt and hops of beer are also important active compounds that interact in both directions with the gut microbiome.”

Methods: “This review summarizes the mechanisms by which polyphenols, fiber, and other beneficial components of beer are fermentatively broken down by the intestinal microbiome to initiate the mucosal immune barrier and thus participate in immune regulation.”

Conclusion: “Beer degradation products have anti-inflammatory, anticoagulant, antioxidant, and glucolipid metabolism-modulating potential. ..The positive effects of bioactive substances in beer in cancer prevention, reduction of cardiovascular events, and modulation of metabolic syndrome make it one of the candidates for microecological modulators.”

Funding: “This study was supported by the Open Research Fund of State Key Laboratory of Biological Fermentation Engineering of Beer, under grant no. K202101.”

Conflict of interest: “CZ and SH were employed by Tsingtao Brewery Co. Ltd.  The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.”

Comment: This seems like a lot to claim for beer.  Vested interest?  Yes.  The State Key Beer Lab is part of the Tsingtao Brewery Co. Ltd, Qingdao, 266100, China and two of the authors work for the company.  Why do this study?  To distract attention from the harmful effects of alcohol consumption (where do I begin?) and from its calories, and instead give beer a health aura.

Beer, alas, is not a health food, best consumed in moderation if at all.

Sorry.

Last week, my industry-influenced study of the week involved kombucha, although the involvement appeared minimal.

All kombucha and placebo drinks were donated by Craft Kombucha. Craft Kombucha did not have any access to data reported in this study. No author has any financial ties with Craft Kombucha. SD was employed by MedStar Health. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

One of the authors of the study, Daniel Merenstein, wrote to object to the way I characterized it (quoted with his permission).

…But you do make it very clear in the article that all industry did was donate free drinks and had no access to data. Not sure how that really deserves being called influence. But my much larger point is this statement, ” It’s easy to find claims for its health benefits if you search for them, but much harder to find science to back them up.  IIf you can demonstrate benefits, you can sell more products.  Hence, this study.”

I think it is exactly the opposite. It is much easier to just say your product works or even better yet to get an influencer to drink your product.

But to actually put your product into scientist’s hands and have no access to data or publication is a huge step forward in food science. Look at JAMA every week, almost all the drug studies are -. The kombucha maker should be applauded for their bravery.

We didn’t going looking for a + outcome but registered our trial and stated a priori exactly what we would be looking at and reporting. This study has many limitations but not the ones you mentioned.

Dan

I appreciate thoughtful and respectful letters like this .  This one especially deserves a response.  Dr. Merenstein implies that this is an investigator-initiated study designed to test an investigator-initiated hypothesis.  Such things do happen.  Unfortunately, they are not the norm.

Here’ what concerned me about the study:

• It involved a kombucha company, even if lightly.  Much evidence demonstrates that company involvement in research ia highly correlated with positive outcomes, so much so that it has a name, the “funding effect.”
• Funding influence is thorougly demonstrated to occur at an unconscious level; investigators do not intend to be influenced, are unaware of the influence, do not recognize it, and deny it (even in the face of much research to the contrary).  The unconscious influence usually shows up in the way the research question is asked or in the interpretation of the results.
• Statements that funders have no involvement in the research have coften been shown to be false.  Exceptions do occur; this may well be one of them.
• This is a one-food study.  It is impossible to control such studies for dietary and other lifestyle confounders unless done in a locked metabolic ward.

On this last point, I am always suspicious of one-food studies because I find it hard to believe that a single food can make a measureable difference in chronic disease outcome.

I would like to know a lot more about how the microbiome works before being convinced that kombucha has any special health benefits (I do think it is delicious).

To their great credit, these authors fully disclose the limitations of their study (it was small) .

Dr. Merenstein says this study is really about the science.  In this case then, the bias is one shared by all scientists—a belief and the desire to prove it,–in this case that kombucha has particular health benefits .  If scientists didn’t have such beliefs and desires, no science would ever get done.

Such personal biases are indeed quite different from bias induced by financial interests with a company making a product.

Perhaps I misjudged this one.  If so, I owe Dr. Merenstein and his colleagues a sincere apology, here offered.

I thank him for writing and giving me the opportunity to discuss these issues again.

(For detailed discussion and references on issues related to industry research funding, see my book, Unsavory Truth: How the Food Industry Skews the Science of What We Eat).

At least five readers recently sent me items about research funding by pecan trade associations and I especially thank Lisa Young and Matthew Rees.

But I will begin with Headline vs. Study from the weekly newsletter (invaluable) Obesity & Energetics Offerings (8-18-23).

• Headline: New Research: Regular Pecan Consumption Could Curb Obesity and Reduce Inflammation.
• University News Article: Adding Pecans to Your Diet Could Help Prevent Obesity and Reduce Inflammation.
• Press-Release: Pecans Give Obesity and Diabetes a Slim Chance: Study Shows the Health Benefits of Pecans, Which May Curb Obesity and Reduce Inflammation.
• Study: Pecans and Its Polyphenols Prevent Obesity, Hepatic Steatosis and Diabetes by Reducing Dysbiosis, Inflammation, and Increasing Energy Expenditure in Mice Fed a High-Fat Diet.

Guess who funded this:

• Funding: We acknowledge funding from the Texas Pecan Board and a grant from the Texas Department of Agriculture.
• Conflicts of Interest: The authors declare no conflict of interest.

Comment: Acknowledged or not, the funding establishes a conflicted interest.  Industry funding influences the outcome of research, whether the researchers recognize it or not.  I will say more about that this week in response to a comment from a reader.

In the meantime, here is another one.

• The study: McKay DL, Eliasziw M, Chen CYO, Blumberg JB. A Pecan-Rich Diet Improves Cardiometabolic Risk Factors in Overweight and Obese Adults: A Randomized Controlled Trial. Nutrients. 2018 Mar 11;10(3):339. doi: 10.3390/nu10030339.
• Acknowledgments: This work was supported by the U.S. Department of Agriculture (USDA) Agricultural Research Service under Cooperative Agreement No. 58-1950-014 and the National Pecan Shellers Association. The National Pecan Shellers Association provided the pecans for the intervention.
• Conflicts of Interest: The authors declare no conflict of interest. The founding sponsors had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, and in the decision to publish the results.

Comment:  The role of the National Pecan Sheller sAssociation is not clear (to me) from these acknowledgments.  Did the trade association initiate or fund the study, or was its involvement strictly in providing pecans?   Is there a difference?  Perhaps.  It is possible for studies involving vested financial interests to be done objectively, but studies of the “funding effect”—a higher probability of favorable outcomes—to be the norm.  Again, I will speak to this point later this week.

In the meantime, for detailed discussion and references of this issue, see my book, Unsavory Truth: How the Food Industry Skews the Science of What We Eat.

My thanks to Paola Baratto for sending this one.

The study: . Intakes of Added Sugars, with a Focus on Beverages and the Associations with Micronutrient Adequacy in US Children, Adolescents, and Teens (NHANES 2003–2018).  Ricciuto L, Fulgoni VL III, Gaine PC, Scott MO, DiFrancesco L.   Nutrients. 2023; 15(15):3285. https://doi.org/10.3390/nu15153285.

Method: This is an analysis of links between added sugars from different kinds of drinks and nutrient adequacy in children using combined data from 8 consecutive NHANES surveys (2003-2018).

Results: I found the results hard to understand because they are presented selectively by age, and they compare nutrient intakes to estimated average requirements.  Here is what I think they mean:

• 2 to 8 year olds: If they got their sugar from flavored milk, they had better calcium intake.
• 9 to 18 year olds: If they got their sugar from soft drinks, coffee, or tea, thei had worse intakes of magnesium and vitamins A and C.  But if they got their sugars from fruit drinks or flavored milk, they had better intake of vitamin C (from the fruit drinks), and of calcium, magnesium, phosphorus, vitamin A, and potassium (from the flavored milk).
• 9 to 18 year olds: Higher intake of added sugars in the overall diet was associated with bettter intake of vitamins and minerals.

Conclusion: The results suggest that the relationship between added sugars intake and micronutrient adequacy depends on the added sugar sources and their nutrient composition.

Funding: The funding for this research was provided by The Sugar Association, Inc. P.C.G. and M.O.S. are employed by The Sugar Association Inc., had input in the study design, and reviewed and edited the manuscript.

Comment: The Sugar Association’s purpose in sponsoring this study is to buttress its argument that sugary drinks and foods have nutrients and, therefore, do not warrant restrictions.  If you get the idea from this study that the more sugary foods you eat, the more nutrients you and your kids get, the Association will be even happier.  Sorry Sugar Association, but it is quite possible to consume adequate intakes of vitamins and minerals without eating sugary foods and doing so will make calories easier to control.  With this study, the Sugar Association got what it paid for.

Thanks to Matthew Kadey for sending this one.  Matcha is a new one for me.

The study: Matcha green tea beverage moderates fatigue and supports resistance training-induced adaptation.  Shigeta M, et al.  Nutrition Journal volume 22, Article number: 32 (2023)

Methods: Healthy, untrained men were randomized into placebo and matcha groups. Participants consumed either a matcha beverage containing 1.5 g of matcha green tea powder or a placebo beverage twice a day and engaged in resistance training programs for 8 (trial 1) or 12 weeks (trial 2).

I posted several examples of industry-funded studies this week in part to reduce my backlog but also because of charges that (1) doing so constitites ad hominem (personal) attacks on authors, (2) I should be focusing on the science, not who paid for it, and (3) I have my own ideological biases.

To the first point:

I do not see industry funding of research as a personal matter.  I see it as a systematic problem.

If I see a study titled “Effect of food product X on disease Y,” I can often guess that

• The food’s manufacturer or trade association paid for it
• The study outcome will be favorable to the funder’s commercial interests

This phenomenon is so systematic that it has a name: The Funding Effect.

To the second point

Researchers who study funding effects, and there are many, note that the scientific conduct of the studies is not usually an issue.  Instead, the influence of the funders shows up in the way the research question is framed or the results are interpreted.

The easiest way to explain the research question bias is to cite the requests for research proposals I often receive from food trade associations.  These say: “we have (this much money) for research to demonstrate the benefits of our product on (one or more of these conditions).”

These groups will not fund research proposals unlikely to show benefits.

As for interpretation, industry-funded studies tend to report null results as positive; I posted several such examples this week.

To the third point

Yes, I have ideological or opinion biases and I try to be as clear as I can about them.  All investigators have such biases; otherwise they wouldn’t be doing science.  We all have something we believe in that we would like to prove.  Such biases are not discretionary; everyone has them.  In contrast, industry funding is about selling products, not science and is completely discretionary; investigators can do science without it.

The evidence?

I review the evidence for what I’ve just said here in my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.

In it, I cite many other books and papers addressing these points.

We all come to the same conclusions:

• Industry funding biases research.  But funded investigators do not recognize the influence, and deny it.
• The statement that accompanies many disclosure statements—“The funder had no influence on the design, conduct, interpretation, or publication of the results,”—is often untrue and must be taken with some degree of skepticism.

I see industry funding of food and nutrition research as a serious problem for public perception.  Even when the research is not conflicted, it appears conflicted.  That alone is a systematic problem.

Nuts are demonstrably good for health.  They have high proportions of fat and, therefore, calories, and the calories can add up quickly.  But a small handful makes a great healthy snack.

Why their trade associations feel they need to produce favorable research is beyond me, but as far as I can tell, they are all competing with each other for market share.

Here are a few examples of nut studies funded by trade associations to convince you to eat more nuts.

The point: Whenever you see a study showing amazing health benefits from one single food, there’s a good chance its trade association paid for it.

NUTS IN GENERAL

The study: Mixed Tree Nuts, Cognition, and Gut Microbiota: A 4-Week, Placebo-Controlled, Randomized Crossover Trial in Healthy Nonelderly Adults.  J. Nutrition.   VOLUME 152, ISSUE 12, P2778-2788, DECEMBER 2022.  DOI:https://doi.org/10.1093/jn/nxac228

Conclusions: These findings indicate a positive effect of nut on cognition following only 4 wk of consumption in a healthy nonelderly sample, as well as upregulation of a microbial taxa associated with gut health. The effects appear to be independent of one another, but further exploration is required in those experiencing cognitive decline and/or gut dysbiosis.

Funding: This study was supported by funding from the INC (International Nut and Dried Fruit Council).

ALMONDS

The study: Almond intake alters the acute plasma dihydroxy-octadecenoic acid (DiHOME) response to eccentric exercise.  Front. Nutr., 09 January 2023. Volume 9 – 2022 | https://doi.org/10.3389/fnut.2022.1042719.

Conclusions: In general, the elevated post-exercise plasma levels of 12,13-DiHOME with almond intake support positive metabolic outcomes for adults engaging in unaccustomed eccentric exercise bouts. Other almond-related benefits for exercisers revealed in this study include reduced feelings of fatigue and tension, better leg-back strength during recovery, and decreased muscle damage during the first day of recovery.

Funding: This work was supported by Almond Board of California, Modesto, CA. The funder had no role in the study design, data collection, analysis and interpretation, the preparation of the manuscript, or in the decision to submit the article for publication.

MACADAMIAS

The study: Macadamia nut effects on cardiometabolic risk factors: a randomised trial  J Nutr Sci. 2023.

Conclusion: Daily consumption of macadamia nuts does not lead to gains in weight or body fat under free-living conditions in overweight or obese adults; non-significant cholesterol lowering occurred without altering saturated fat intake of similar magnitude to cholesterol lowering seen with other nuts.

Funding: This study was funded by Hort Innovation, Sydney, Australia (Project code MC17005).  J. J., K. O. and F. M. – None; J. S., S. R. and C. H. have received research funding through their institution from Hort Innovation, Sydney, Australia.  Note: Hort Innovation is a grower-owned, not-for-profit research and development corporation with the goal of creating value for horticulture growers and those across the horticulture supply chain. It invests more than $120 million in R&D, marketing and trade programs on behalf of industry.

PEANUTS

The study:  Urinary Phenolic Metabolites Associated with Peanut Consumption May Have a Beneficial Impact on Vascular Health Biomarkers. Antioxidants. 2023; 12(3):698. https://doi.org/10.3390/antiox12030698.

Conclusion:  the present study shows for the first time that regular peanut and peanut butter consumption could have a positive impact on vascular biomarkers in healthy young adults.

Funding: This research was supported by funding from the Peanut Institute

Thanks to Arjan van Groningen for this one.

The study:  The Effect of Non-Nutritive Sweetened Beverages on Postprandial Glycemic and Endocrine Responses: A Systematic Review and Network Meta-analysis. Zhang, R.; Noronha, J.C.; Khan, T.A.; McGlynn, N.; Back, S.; Grant, S.M.; Kendall, C.W.C.; Sievenpiper, J.L. Nutrients 2023, 15, 1050. https://doi.org/10.3390/nu15041050.

Conclusions: The available evidence suggests that NNS beverages sweetened with single or blends of NNS have no acute metabolic and endocrine effects, similar to water. These findings provide support for NNS beverages as an alternative replacement strategy for SSBs in the acute postprandial setting.

Funding: This work was supported by an unrestricted grant from the Institute for the Advancement of Food and Nutrition Sciences (IAFNS). The grant was awarded through a competitive request for the proposal process. The sponsor was not involved in the development of the study protocol and design, execution, analyses, interpretation of the data, or decision to publish. The protocol and results were presented to the Low- And No-Calorie Sweeteners Scientific Committee of IAFNS on several occasions with an opportunity for scientific dialogue.

Comment:  IAFNS is the new name for ILSI North America, a classic industry front group.  To its credit, the authors disclose the involvement of IAFNS in this review.  Check out the Conflict-of-Interest declarations from this group; they are legendary.

Conflicts of Interest: J.C.N. has worked as a clinical research coordinator at INQUIS Clinical Research. He has also received research support from Glycemia Consulting Inc. T.A.K. has received research support from the Canadian Institutes of Health Research (CIHR), the International Life Science Institute (ILSI), and the National Honey Board. He has taken honorariums for lectures from the International Food Information Council (IFIC) and the Institute for the Advancement of Food and Nutrition Sciences (IAFNS; formerly ILSI North America). He is funded by the National Honey Board. N.M., was a former employee of Loblaw Companies Limited, and is a current employee of Enhanced Medical Nutrition. She has completed consulting work for contract research organizations, restaurants, start-ups, the International Food Information Council, and the American Beverage Association, all of which occurred outside of the submitted work. S.M.G. has received honoraria from Dietitians of Canada and Diabetes Canada for the development and delivery of educational resources on the glycemic index in the past five years. C.W.C.K has received grants or research support from the Advanced Food Materials Network, Agriculture and Agri-Foods Canada (AAFC), the Almond Board of California, Barilla, the Canadian Institutes of Health Research (CIHR), the Canola Council of Canada, the International Nut and Dried Fruit Council, the International Tree Nut Council Research and Education Foundation, Loblaw Brands Ltd., the Peanut Institute, Pulse Canada, and Unilever. He has received in-kind research support from the Almond Board of California, Barilla, the CaliforniaWalnut Commission, Kellogg Canada, Loblaw Companies, Nutrartis, Quaker (PepsiCo), the Peanut Institute, Primo, Unico, Unilever, and WhiteWave Foods/Danone. He has received travel support and/or honoraria from Barilla, the CaliforniaWalnut Commission, the Canola Council of Canada, General Mills, the International Nut and Dried Fruit Council, the International Pasta Organization, Lantmannen, Loblaw Brands Ltd., the Nutrition Foundation of Italy, Oldways Preservation Trust, Paramount Farms, the 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, the International Pasta Organization, the McCormick Science Institute, and Oldways Preservation Trust. He is a founding member of the International Carbohydrate Quality Consortium (ICQC), the Chair 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 is a Director of Glycemia Consulting and the  Toronto 3D Knowledge Synthesis and Clinical Trials foundation. J.L.S. has received research support from the Canadian Foundation for Innovation, the Ontario Research Fund, the Province of Ontario
Ministry of Research and Innovation and Science, the Canadian Institutes of health Research (CIHR),  Diabetes Canada, the American Society for Nutrition (ASN), the International Nut and Dried Fruit Council (INC) Foundation, the National Honey Board (U.S. Department of Agriculture [USDA] honey “Checkoff” program), the Institute for the Advancement of Food and Nutrition Sciences (IAFNS; formerly ILSI North America), Pulse Canada, the Quaker Oats Center of Excellence, the United Soybean Board (USDA soy “Checkoff” program), 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), the Plant Protein Fund at the University of Toronto (a fund which has received contributions from IFF), and the Nutrition Trialists Network Fund at the University of Toronto (a fund established by an inaugural donation from the Calorie Control Council). He has received food donations to support randomized controlled trials from the Almond Board of California, the California Walnut Commission, the Peanut Institute, Barilla, Unilever/Upfield, Unico/Primo, Loblaw Companies, Quaker, Kellogg Canada, WhiteWave Foods/Danone, Nutrartis, and Dairy Farmers of Canada. He has received travel support, speaker fees and/or honoraria from ASN, Danone, Dairy Farmers of Canada, FoodMinds LLC, Nestlé, Abbott, General Mills, Nutrition Communications, the International Food Information Council (IFIC), the Calorie Control Council, the International Sweeteners Association, and the International Glutamate Technical Committee. He has or has had ad hoc consulting arrangements with Perkins Coie LLP, Tate & Lyle, Phynova, and Inquis Clinical Research. He is a former member of the European Fruit Juice Association Scientific Expert Panel and a former member of the Soy Nutrition Institute (SNI) Scientific Advisory Committee. He is on the Clinical Practice Guidelines Expert Committees of Diabetes Canada, the European Association for the study of Diabetes (EASD), the Canadian Cardiovascular Society (CCS), and Obesity Canada/Canadian Association of Bariatric Physicians and Surgeons. He serves or has served as an unpaid member of the Board of Trustees and an unpaid scientific advisor for the Carbohydrates Committee of IAFNS. He is a member of the International Carbohydrate Quality Consortium (ICQC), an Executive Board Member of the Diabetes and Nutrition Study Group (DNSG) of the EASD, and a Director of the Toronto 3D Knowledge Synthesis and Clinical Trials foundation. His spouse is an employee of AB InBev. R.Z. and S.B. have no conflicts of interest to declare.