Currently browsing posts about: Sponsored-research

I’m kind of a dairy agnostic.  If you like dairy foods, fine; if not, don’t eat them.

But the arguments about them are fierce, and the current Dietary Guidelines for Americans advise choosing low-fat alternatives.

So when I saw the title of this study, I wondered whether it had been funded by the dairy industry.  It was not, although some of the investigators have dairy industry ties.

The study: Whole-fat dairy products do not adversely affect adiposity or cardiometabolic risk factors in children in the Milky Way Study: a double-blind randomized controlled pilot study.  Analise Nicholl, Kane E Deering, Kate Evelegh, Philippa Lyons-Wall, David Lawrence, Trevor A Mori, Mario Kratz, Therese A O’Sullivan.  The American Journal of Clinical Nutrition, Volume 114, Issue 6, December 2021, Pages 2025–2042, https://doi.org/10.1093/ajcn/nqab288

Conclusions: Our results suggest that although changing from whole-fat to reduced-fat dairy products does reduce dairy fat intake, it does not result in changes to markers of adiposity or cardiometabolic disease risk in healthy children.

Acknowledgments: …The Principal Investigator, TAOS, was awarded funding in 2011 for a previous study from the Dairy Health and Nutrition Consortium. MK has received honoraria and reimbursements for travel as well as a research grant from several dairy-related organizations, including National Dairy Council/Dairy Management Inc., Dairy Farmers of Canada, the Dutch Dairy Association (Nederlandse Zuivel Organisatie), Dairy Australia, and the French Interbranch Organization (CNIEL). All other authors report no conflicts of interest.

Notes: …No funding body played any role in the Milky Way Study design, implementation, analysis or interpretation of the data, or publication. The Milky Way Study received no funding from any dairy or food industry organization or affiliation toward study research, dairy product purchase or provision, child assessments, project personnel, or publication.

Comment: No funding body needed to be involved in this study to raise questions of conflicted interests; two of the authors report financial ties to dairy companies.  At the very least, these ties give the appearance of conflict of interest.  Are dairy foods good, bad, or indifferent for health?  My guess is that like pretty much everything else in the diet, it depends on everything else you are eating (unless you are lactose or dairy protein intolerant, in which case you know to avoid dairy foods).  The underlying purpose of this study is to encourage sales of full-fat dairy products to children.   Is that a good idea?  You decide.

Reference: For a summary of research on the “funding effect”—the observation that research sponsored by food companies almost invariably produces results favorable to the sponsor’s interests, but that recipients of industry funding typically do not recognize its influence—see my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.

My thanks go to New Zealand reader Kirsten for sending this one.

The study: Exploring the Links between Diet and Inflammation: Dairy Foods as Case Studies. Julie M Hess, Charles B Stephensen, Mario Kratz, Bradley W Bolling.  Advances in Nutrition, Volume 12, Issue Supplement_1, October 2021, Pages 1S–13S,

Note: This article was intended as a review article based on presentations made by CBS, MK, and BWB at the American Society for Nutrition 2020 LIVE ONLINE Conference 7–10 June 2020.

Background: Systemic chronic inflammation may be a contributing factor to many noncommunicable diseases, including diabetes, cardiovascular disease, and obesity. An emerging body of evidence indicates that consuming certain foods, including dairy foods like milk, cheese, and yogurt, may be linked to a decreased risk for inflammation.

Method: Review of research on dairy foods and inflammation.

Conclusion: While there is currently insufficient evidence to prove an “anti-inflammatory” effect of dairy foods, the substantial body of clinical research discussed in this review indicates that dairy foods do not increase concentrations of biomarkers of chronic systemic inflammation.

Funding: The ASN Nutrition 2020 session that this article is based on was supported by the National Dairy Council. This support included honoraria for MK and BWB. The authors reported no funding received for this study.

Author disclosures: JMH was an employee of the National Dairy Council at the time this article was written. MK has received honoraria and reimbursements of travel costs as well as research funding from dairy-related organizations, including the National Dairy Council, Dairy Management, Inc., Dairy Farmers of Canada, the Dutch Dairy Organization (Nederlandse Zuivel Organisatie), Dairy Australia, and the French Dairy Interbranch Organization (CNIEL). BWB has received research funding for dairy-related projects from University of Wisconsin Dairy Innovation Hub, the National Dairy Council, and USDA National Institute of Food and Agriculture (NIFA) HATCH WIS02094. The other author reports no conflicts of interest.

Comment: This is a study by dairy-funded authors with an interesting spin.  The research review found no anti-inflammatory effect of dairy foods but concludes that they have a benefit: they don’t make inflammation worse.  I realize that dairy foods have a bad reputation among some eaters, but I wish the dairy industry didn’t sponsor research so blatantly in its self-interest.  I also wish we could get away from one-food research.  One food cannot possibly make a substantial difference in the diets of reasonably healthy people who eat a variety of foods.  I am all for eating dairy foods if you like them, especially from well-treated animals.  They have a place in healthful diets—or not ,if you don’t like or want to eat them.

Reference: For a summary of research on the “funding effect”—the observation that research sponsored by food companies almost invariably produces results favorable to the sponsor’s interests but that recipients of industry funding typically do not recognize its influence—see my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.

I learned about this study from an article in FoodNavigator.com, “Baobab industry welcomes study linking the fruit to good gut health.”

The title raised the question, “Who funded this?”  Bingo, as it turns out.

Baobabs are enormous African trees that produce a highly fibrous fruit.

I can’t say it looks particularly yummy.  In fact, it is described as “floury, dry, and powdery” and works best as a powdered ingredient.

But the baobab industry?  Who knew such an entity existed?

It does.  Hence this study:

The study: A Pectin-Rich, Baobab Fruit Pulp Powder Exerts Prebiotic Potential on the Human Gut Microbiome In Vitro.  Martin Foltz, Alicia Christin Zahradnik, Pieter Van den Abbeele, Jonas Ghyselinck, Massimo Marzorati.  Microorganisms. 2021 Sep 17;9(9):1981.

Methods: Test tube mixing of baobab powder with colonic bacteria.

Results: Baobab fruit pulp powder boosted colonic acidification across three simulated human adult donors due to the significant stimulation of health-related metabolites.

Conclusions: Overall, Baobab fruit pulp powder fermentation displayed features of selective utilization by host microorganisms and, thus, has promising prebiotic potential.

Funding: The studies described in this manuscript were performed at the request of and were funded by Döhler, 94295 Darmstadt, Germany  Surprise!  This company makes baobab powder.

Conflict of interest:  M.F. and A.C.Z. are employees of Döhler. While M.F. participated in the design of the study, the interpretation of the data, and the revision of the manuscript, M.F. did not participate in the collection and analyses of data.

Comment: No food, product, or ingredient is too obscure to avoid industry attempts to demonstrate that it can be marketed as a “superfood” (see, for example, this product).

Reference: For a summary of research on the “funding effect”—the observation that research sponsored by food companies almost invariably produces results favorable to the sponsor’s interests but that recipients of industry funding typically do not recognize its influence—see my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.

I have a long-standing interest in pet food (see Feed Your Pet Right, and Pet Food Politics: The Chihuahua in the Coal Mine) and in conflicts of interest in research (see Unsavory Truth: How Food Companies Skew the Science of What We Eat).  Knowing of both, a reader, Teresa Reinhardt, alerted me to this one.

The study:  Investigation of diets associated with dilated cardiomyopathy in dogs using foodomics analysis.  Caren E. Smith, Laurence D. Parnell, Chao-Qiang Lai, John E. Rush & Lisa M. Freeman.  Scientific Reports volume 11, Article number: 15881 (2021).

Purpose: to identify specific pet food ingredients associated with Dilated Cardiomyopathy (DCM) in dogs.

Methods: Metabolomic profiling of 25 diets associated with canine DCM and 9 diets not associated with DCM.

Results: “Four diet ingredients distinguished the two diet groups (peas, lentils, chicken/turkey, and rice). Of these ingredients, peas showed the greatest association with higher concentrations of compounds in 3P/FDA diets [the ones associated with DCM].“

Funding:  “This work was funded in part by Nestlé Purina PetCare and the Barkley Fund. This work was funded in part by United States Department of Agriculture project number 8050-51000-107-00D, and this entity had no part in the design of the experiments, in the collection, analysis and interpretation of data, nor in composing the manuscript.”

Conflicts of interest: “In the last 3 years, Dr. Freeman has received research funding from, given sponsored lectures for, and/or provided professional services to Aratana Therapeutics, Elanco, Hill’s Pet Nutrition, Nestlé Purina PetCare, P&G Pet Care (now Mars), and Royal Canin. In the last 3 years, Dr. Rush has received research funding from, given sponsored lectures for, and/or provided professional services to Aratana Therapeutics, Boehringer Ingelheim, Elanco, IDEXX, Nestlé Purina PetCare, and Royal Canin. None of the other authors has any competing interests to declare.”

Comment:  DCM is a common heart disease affecting dogs, with a prevalence that exceeds 50% in some breeds (e.g., Doberman Pinschers). More than 1100 cases have been reported to the FDA.

Despite endless speculation, its cause is unknown.  Much attention has focused on one or another dietary deficiencies or specific components (e.g., grains).  As the authors explain:

The diets reported to be associated with DCM often are marketed as “grain-free” and often contain certain ingredients that became part of commercial foods relatively recently (e.g., pulses, potatoes, and sweet potatoes) and lack others (such as rice or corn). Most of the ingredients that are included in the associated diets are also found in human diets, but dogs often eat them in even higher quantities because most dogs eat a single commercial pet food, rather than a variable mixture of multiple foods as humans do.

I think there three issues need further discussion.

(1)  Grains. Some pet owners believe that dogs should not eat grains. They buy pet foods that do not contain them.  This study identified grains only in the pet foods that were not associated with DCM.  Ms. Reinhardt also sent a link to a commentary from someone who questions this finding and raises other critical points about the study.  Dogs are fully capable of digesting grains and grains have been used safely in pet foods for decades.  The FDA describes the association of DCM with on its website.  What’s needed to resolve the peas question is a long-term (years, not months) trial of diets with and without peas.  The pet food industry has no incentive to pay for something like that.

(2)  The funding effect.  Nestlé Purina PetCare [no relation] paid for the study, and two of the authors consult widely for pet food companies.  Grains are inexpensive pet food ingredients and it is to Nestlé’s interest to have evidence demonstrating that grains do no harm.  How much influence did this company have over the research?  The conflict of interest statement is oddly worded.  The USDA funder is stated to have stayed out of the study, but the statement does not seem to apply to Nestlé, suggesting company influence.

(3)  Pet food research funding in general.  This study had some USDA funding, but government funding for pet food research is rare.  Most pet food research is funded by pet food companies, and most focuses on taste preferences.  Remarkably little research is designed to answer questions about which diets are better than others—a big issue because most pets eat commerical pet foods designed to take care of their complete nutritional needs.

This study identified peas as most strongly associated with DCM.  Pea protein is a main ingredient in plant-based meat alternatives.  It would be good to know more about the dietary effects of peas and pea proteins.

If nothing else this study demonstrates why pet food research matters.  We only have one food system, and pet food is very much a part of that system.

Jackfruit?  No, I’m not kidding.

For one thing, it’s JSTOR Daily’s Plant of the Month: “The newly hot alternative to meat has a long history.”

Jackfruit is not new in South Asia and its surrounding regions, where it has been a culturally significant foodstuff for centuries. Nor is jackfruit new in the West. Rather, it has a long and disquieting history: British imperialists wielded jackfruit as a tool to provide cheap nutrition to enslaved and coerced laborers throughout their empire.

Here’s what it looks like on the tree:

And off:

If you are in the business of selling Jackfruit, or products made from it, you will want research demonstrating health benefits.

Voila!

The study: Efficacy of green jackfruit flour as a medical nutrition therapy replacing rice or wheat in patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study  Gopal Rao, K. Sunil Naik, A. G. Unnikrishnan & James Joseph.  Nutrition & Diabetes volume 11, Article number: 18 (2021)

Methods: This was a randomized, double-blind, placebo-controlled study of patients with type-2 diabetes who were being treated with oral antihyperglycemic agents.  They were either given jackfruit flour 30 g/day (Group A) or placebo flour (Group B) for 12 weeks.

Results: Patients from Group A had a better reduction in glycosylated hemoglobin, fasting plasma glucose, and postprandial plasma glucose than patients in Group B.

Conclusion: This study demonstrates the efficacy of jackfruit flour in glycemic control as medical nutrition therapy replacing an equal volume of rice or wheat flour in daily meal.

Funding: Diet Fibre 365 Food Products Pvt Ltd, India.

Acknowledgment: “The authors would like to acknowledge Abiogenesis Clinpharm Pvt Ltd, Hyderabad, for medical writing assistance funded by Diet Fibre 365 Food Products Pvt Ltd, Mumbai, India.”

Competing interests: JJ is the inventor of Jackfruit 365™ Green Jackfruit Flour with a pending patent and CEO of God’s Own Food Solutions Pvt Ltd which along with its subsidiary Diet Fibre 365 Food Products Pvt Ltd manufactures and markets the product. AGR, KSN, and UAG have no conflict of interest to declare.

Comment: This is a classic example of the funding effect in nutrition research.  The author owns the Jackfruit flour and the company that markets it, and the funder wrote (OK, helped to write) the paper.  The results were predictable.

Reference: For a summary of research on the “funding effect”—the observation that research sponsored by food companies almost invariably produces results favorable to the sponsor’s interests, but that recipients of industry funding typically do not recognize its influence—see my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.

This one is so unusual that it demands attention.

The study: Thirty Days of Montmorency Tart Cherry Supplementation Has No Effect on Gut Microbiome Composition, Inflammation, or Glycemic Control in Healthy Adults.  Angela R. Hillman1* and Bryna C. R. Chrismas  Front. Nutr., 16 September 2021

Hypothesis: Polyphenols in Montmorency Tart Cherry products would influence the gut microbiome composition,which would modulate changes in inflammatory markers and glucose regulation.

Methods: Four groups of subjects consumed either concentrate or freeze-dried capsules or their corresponding placebos for 30 days.

Results: Only one of several inflammatory markers was reduced.  There were no changes in insulin, glycated albumin, or composition of bacterial phyla, families, or subfamilies for the duration of this study nor was there a change in species richness.

Conclusion: These data suggest that 30 days of MTC supplementation does not modulate the gut microbiome, inflammation, or improve glycemic control in a healthy, diverse group of adults.

Funding: This study was funded by a grant from The Cherry Marketing Institute.

Comment: I have previously posted several studies paid for by cherry trade associations; these yielded results demonstrating truly remrkable health benefits of cherry consumption (see this one on prevention of dementia, for example).

But this study found cherry extracts to do nothing special.

Applause to these authors!

All fruits have antioxidants of one kind or another.  Eating a variety of delicious fruits should be a pleasure, not a medical duty.

It’s past the cherry season in the Northeast where I live, but if you can get them, enjoy!

A sharp-eyed reader, Paula Rochelle, sent me this one.  From the title alone, she suspected industry sponsorship.  Good thinking!

The Study: Dietary strawberry improves cognition in a randomised, double-blind, placebo-controlled trial in older adults.

Dietary intervention: For 90 days: “12 g of a lyophilised, standardised blend of SB sourced from equal parts of Albion, San Andreas, Camino Real and Well-Pict 269 varieties, twice daily (24 g/d, equivalent to two cups per serving of fresh SB).”

Results: “This study found that 90 d of dietary intervention with SB resulted in (1) improved word recognition and (2) improved spatial learning and memory in a virtual navigation task among healthy older adults.”

Conclusion: “In conclusion, these findings suggest that the inclusion of SB in the diet may aid in preserving some aspects of hippocampal cognitive function during normal ageing.”

Funding: The study was funded by the U.S. Department of Agriculture and California Strawberry Commission.

Conflicts of interest:  The authors declare that they have no conflicts of interest.

Comment: This study received partial support from USDA as part of its effort to promote fruit-and-vegetable consumption.  The California Strawberry Commission wants people to buy more strawberries.   It summarizes the research it sponsors on its website.  Everyone knows that eating fruits and vegetables is good for health.  Why does the Strawberry Commission go to all this trouble to demonstrate that strawberries are good for health?  My guess: to compete with blueberries for market share.  This, like other such studies, is about marketing.  The authors do not view strawberry industry funding as a source of conflicted interests.  They should.

Reference: For a summary of research on the “funding effect”—the observations that research sponsored by food companies almost invariably produces results favorable to the sponsor’s interests and that recipients of industry funding typically did not intend to be influenced and do not recognize the influence—see my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.

The study: Impact of low-fat and full-fat dairy foods on fasting lipid profile and blood pressure: exploratory endpoints of a randomized controlled trial.  Kelsey A Schmidt, et al. The American Journal of Clinical Nutrition, nqab131, https://doi.org/10.1093/ajcn/nqab131.  Published: 13 July 2021

Background: “Dietary guidelines traditionally recommend low-fat dairy because dairy’s high saturated fat content is thought to promote cardiovascular disease (CVD). However, emerging evidence indicates that dairy fat may not negatively impact CVD risk factors when consumed in foods with a complex matrix.”

Method: “Participants were then randomly assigned to 1 of 3 diets, either continuing the limited-dairy diet or switching to a diet containing 3.3 servings/d of either low-fat or full-fat milk, yogurt, and cheese for 12 wk.”

Conclusions: “In men and women with metabolic syndrome, a diet rich in full-fat dairy had no effects on fasting lipid profile or blood pressure compared with diets limited in dairy or rich in low-fat dairy. Therefore, dairy fat, when consumed as part of complex whole foods, does not adversely impact these classic CVD risk factors.”

Funding: “National Dairy Council, Dairy Farmers of Canada, Dutch Dairy Association (Nederlandse Zuivel Organisatie), Dairy Australia, and the French Dairy Interbranch Organization (CNIEL),” and NIH and others.

Conflict of interest: “This study was initiated by the principal investigator (MK). The dairy-related funding organizations suggested changes to details of the study design prior to the conduct of the study, some of which were implemented. Otherwise, the funding organizations had no impact on the design or conduct of the trial or the analysis and interpretation of study data.”

Comment: Let’s give these investigators high marks for disclosing that the dairy funders influenced the design of the study, which, as we know from the data of Lisa Bero and her colleagues, is the place where biases caused by industry funding most typically show up.  Food companies that fund research are looking for benefits; they won’t risk study designs that might yield inconvenient results.

Reference: For a summary of research on the “funding effect”—the observations that research sponsored by food companies almost invariably produces results favorable to the sponsor’s interests and that recipients of industry funding typically did not intend to be influenced and do not recognize the influence—see my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.