Currently browsing posts about: Sponsored-research

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.

I know I’ve already posted one of these this week, but this one is too good not to share.

Let’s start with the press coverage: Snack yourself young: Study investigates the effects of daily almond consumption on wrinkles

A study by American research found that eating almonds daily reduces wrinkle severity – along with improving skin pigmentation – in postmenopausal women.

The 2021 study – published in Nutrients and funded by the Almond Board of California – expands upon findings of a 2019 study​​ that found there may be more than one reason to add almonds to a daily skin care routine.​​

And here’s the study in question: Prospective Randomized Controlled Trial on the Effects of Almonds on Facial Wrinkles and Pigmentation.  Authors: Sivamani RK, Rybak I, Carrington AE, Dhaliwal S, et al.  Nutrients. 2021; 13(3):785

This is not their first on this topic.  See: Prospective randomized controlled pilot study on the effects of almond consumption on skin lipids and wrinkles.  Author: Sivamani RK, Foolad N, Vaughn AR, Rybak I, et al   Phytother Res. 2019 Dec;33(12):3212-3217

Nor are these the first studies to link specific foods to wrinkle prevention.  I’ve written previously about a study on mangos and wrinkle prevention, sponsored—of course—by a mango trade association.

I wish companies and trade associations would stop doing studies of one food and some health outcome. Diets that contain reasonable proportions of fruits, vegetables, and whole grains are demonstrably healthy.  Can any one food really make all that much difference?

The sellers of these foods would like you to think they are “superfoods.”  Alas, no such thing exists.  But it’s a great marketing strategy.

As for sponsored research in general?

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 was of course interested to see this press release from Nature:

Health researchers report funder pressure to suppress results: Small study hints that interference from bodies funding research into public-health issues such as nutrition and exercise might be more common than realized.

It referred to a study published in PLoS One: ““He who pays the piper calls the tune”: Researcher experiences of funder suppression of health behaviour intervention trial findings.”

This was a small study, but its results confirm what has long been suspected.  Funders call the tune.  These results are entirely consistent with those from similar examinations of studies paid for by cigarette, chemical, and drug companies, as I discuss in my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.