Currently browsing posts about: Conflicts-of-interest

A reader in Australia, Anthony Power, sent me this one, which he noticed discussed in an article in the Australian The Conversation.”

This one is not obviously funder takes all.  Indeed, it might need to be categorized as a rare example of an industry-funded study with results unfavorable to the sponsor’s interests.

The study: A Systematic Review and Meta-Analysis of Randomized Controlled Trials on the Effects of Oats and Oat Processing on Postprandial Blood Glucose and Insulin Responses.  Kathy Musa-Veloso, Daniel Noori, Carolina Venditti , Theresa Poon ¹, Jodee Johnson ², Laura S Harkness ², Marianne O’Shea ², YiFang Chu ²  J Nutr.  2021 Feb 1;151(2):341-351.  doi: 10.1093/jn/nxaa349.

Objectives: The study objective was to determine the effects of differently processed oats on the postprandial blood glucose and insulin responses relative to refined grains.

Conclusions: A disruption in the structural integrity of the oat kernel is likely associated with a loss in the glycemic benefits of oats.

Funding: The systematic review and meta-analysis, as well as the writing of the manuscript, were funded by PepsiCo, Inc.

Conflicts of interest: Author disclosures: KM-V, DN, CV, and TP are employees of Intertek Health   ciences Inc., which has provided consulting services to PepsiCo, Inc. JJ, MO, and YC are employees of PepsiCo, Inc., which manufactures oatmeal products under the brand name Quaker Oats and which funded this systematic review and meta-analysis. LSH is a former employee of PepsiCo, Inc. The views expressed in this article are those of the authors and do not
necessarily reflect the opinion or policies of Intertek Health Sciences Inc. or PepsiCo, Inc.

Comment: Oats are good sources of soluble fiber which in some studies helps lower blood cholesterol levels.  PepsiCo owns Quaker Oats, which makes oatmeals of varying degree of integrity.  The least processed ones, according to this review, do the best job.  This means that quick oats have less of a beneficial effect than the longer-to-cook less processed varieties.  As the paper puts it: “The postprandial glycemic and insulin responses
with thin/instant/quick oats were not significantly different from those elicited by the refined grain control.”

PepsiCo currently extols the health benefits of oatmeal on its website, without making a distinction between the Instant and Need-to-be-Cooked-Longer varieties.  Will it change its website in response to this study?  We will see in due course.

Thanks to Georgene Grover for sending this one, with this comment: “What about this? Ten prunes a day seems excessive!”

The study:  The Role of Prunes in Modulating Inflammatory Pathways to Improve Bone Health in Postmenopausal Women.  Janhavi J Damani, Mary Jane De Souza, Hannah L VanEvery, Nicole CA Strock, and Connie J Rogers. Adv Nutr 2022;00:1–17.

Purpose:  Prunes (dried plums; Prunus domestica L.) have been studied as a potential whole-food dietary intervention to mitigate bone loss in preclinical models of osteoporosis and in osteopenic postmenopausal women.

Method: This is a review of previous studies.  It summarizes findings from preclinical and clinical studies that have assessed the effect of prunes on oxidative stress, inflammatory mediators, and bone outcomes. Most of the studies that reported effects required 100 grams per day of prunes (about 10 per day).

Conclusion: Overall, evidence from in vitro, preclinical studies, and limited clinical studies suggests the potential role of prunes in ameliorating bone loss.

Funding and COI: Supported by the California Prune Board provided funding to MJDS and CJR. Publication funds came from the Hershey Company endowment, Department of Nutritional Sciences, Penn State University. California Dried Plum Board (grant no. 100804). Author disclosures: CJR is member of the Nutrition Advisory Panel for the California Dried Plum Board. The other authors report no conflicts of interest.

Comment: This is a standard industry-funded paper with a predictable outcome.  As far as I can tell, every food trade association is funding research that can help with marketing.  Even prunes.

Prunes are fine, but studies of one food don’t really tell you anything about diets as a whole.  Eat prunes if you like them.  Ten prunes means ten plums.  Seems like a lot, no?

Yesterday I reported about the COSMOS clinical trial demonstrating reductions in mortality among people taking cocoa flavanol supplements.

That trial had another arm: multivitamin supplements.

The study: Multivitamins in the Prevention of Cancer and Cardiovascular Disease: The COSMOS Randomized Clinical Trial.  Sesso HD et al.  The American Journal of Clinical Nutrition, nqac056, https://doi.org/10.1093/ajcn/nqac056

Conclusion: The supplements did not reduce cardiovascular disease, cancer, or all-cause mortality in older men and women.

Funding: The COcoa Supplement and Multivitamin Outcomes Study (COSMOS) is supported by an investigator-initiated grant from Mars Edge, a segment of Mars dedicated to nutrition research and products, which included infrastructure support and the donation of study pills and packaging. Pfizer Consumer Healthcare (now part of GSK Consumer Healthcare) provided support through the partial provision of study pills and packaging.

Conflicts of interest: Drs. Sesso and Manson reported receiving investigatorinitiated grants from Mars Edge, a segment of Mars Incorporated dedicated to nutrition research and products, for infrastructure support and donation of COSMOS study pills and packaging,
Pfizer Consumer Healthcare (now part of GSK Consumer Healthcare) for donation of COSMOS study pills and packaging during the conduct of the study. Dr. Sesso additionally reported receiving investigator-initiated grants from Pure Encapsulations and Pfizer Inc. and honoraria
and/or travel for lectures from the Council for Responsible Nutrition, BASF, NIH, and American Society of Nutrition during the conduct of the study. No other authors reported any conflicts of interest.

Comment: Pfizer, of course, makes Centrum multivitamin supplements aimed at older adults.

I was surprised by this part of the trial because previous studies have also shown no consistently beneficial effect of supplementation of individual vitamins or multivitamins on disease risk.  Pfizer must have hoped to find benefits for Centrum.  This is a rare industry-supported study that showed no benefits and is, therefore, worth attention.

I learned about this one from a PR tweet from @Brigham Research: “Dr. JoAnn Manson…& colleagues report the main findings of the first ever randomized trial of a cocoa flavanol supplement on cardiovascular disease endpoints.”

Its spectacular results:  Supplementation with cocoa flavanols led to a 27% reduction in deaths from cardiovascular disease among all participants taking the supplement, and a 39% reduction in those deaths when they excluded participants who did not take the pills properly.

From taking cocoa flavanol supplements?

Who paid for this?

Bingo.

The study (still in preprint): Effect of Cocoa Flavanol Supplementation for Prevention of Cardiovascular Disease Events: The COSMOS Randomized Clinical Trial.  Sesso HD, et al.  American Journal of Clinical Nutrition, nqac055, https://doi.org/10.1093/ajcn/nqac055

Conclusion: “Cocoa extract supplementation did not significantly reduce total cardiovascular events among older adults but reduced CVD death by 27%….”

Funding: “The Cocoa Supplement and Multivitamin Outcomes Study (COSMOS) is supported by an investigator-initiated grant from Mars Edge, a segment of Mars dedicated to nutrition research and products, which included infrastructure support and the donation of study pills and packaging…[and other sources].

Conflicts of interest: Drs. Sesso and Manson reported receiving investigatorinitiated grants from Mars Edge, a segment of Mars Incorporated dedicated to nutrition research and products, for infrastructure support and donation of COSMOS study pills and packaging,
Pfizer Consumer Healthcare (now part of GSK Consumer Healthcare) for donation of COSMOS study pills and packaging during the conduct of the study. Dr. Sesso additionally reported receiving investigator-initiated grants from Pure Encapsulations and Pfizer Inc. and honoraria
and/or travel for lectures from the Council for Responsible Nutrition, BASF, NIH, and American Society of Nutrition during the conduct of the study. No other authors reported any conflicts of interest.

Comment: Déjà vu all over again.

Mars, as I described in detail in Unsavory Truth, has been trying to make you think that chocolate is a health food (M&Ms!) for decades. It created a special brand, CocoaVia, for this purpose.  Here is an excerpt:

In 1982, Mars established a chocolate research center in Brazil.[i]  Its scientists were particularly interested in cocoa flavanols, a category of flavonoids with antioxidant, anti-inflammatory, and other heart-healthy effects.  Through the 1980s and 1990s, Mars’ scientists produced studies suggesting such benefits.

Alas, cocoa flavanols come with complications.  They taste bitter (dark chocolate contains more of them).  They are present in such small amounts that you would have to eat a quarter to a full pound of chocolate a day to achieve cardiovascular benefits.[ii]  Worse, they are destroyed by traditional chocolate processing.[iii]  The losses may explain why a Hershey-funded clinical trial failed to find neuropsychological or cardiovascular benefits from eating dark chocolate when compared to a placebo.[iv]

But to return to CocoaVia: Mars developed a process to preserve the cocoa flavanols during processing, and combined the rescued flavanols with cholesterol-lowering plant sterols to make chocolate bars and chocolate-covered almonds.  By 2002, the company decided that it had enough research to promote CocoaVia candies as heart-healthy.[v]  As the New York Times put it, Mars was on a “corporate quest to transform chocolate into a healthy indulgence.”[vi]  Mars marketed the candy bars—two a day, no less—as a means to increase blood flow, lower blood pressure, and reduce the risk for heart disease.

The FDA takes a dim view of unproven claims like “chocolate prevents heart disease.”  In 2006, the agency sent Mars a warning letter complaining that claims like “promotes a healthy heart” and “now you can have real chocolate pleasure with real heart health benefits,” were false, misleading, and easily misinterpreted…Chocolate, the FDA pointed out, is high in saturated fat (it didn’t mention sugar).   Furthermore, the claim “Cocoa Via Chocolate Bars contain natural plant extracts that have been proven to reduce bad cholesterol (LDL) by up to 8%,” meant that Mars was advertising chocolate as a drug.  If Mars wanted to make drug claims, it would need to conduct clinical trials to prove that eating CocoaVia chocolate bars prevented heart disease.[vii]

Rather than run the financial and scientific risk of doing that, Mars gave up on candy bars and began marketing CocoaVia in pills and powder as a “daily cocoa extract supplement.”  In doing this, Mars could take advantage of the more lenient marketing claims allowed by the Dietary Supplement Health and Education Act (DSHEA) of 1994. This act permits “structure/function” claims, those proposing that a supplement is good for some structure or function of the body.  Under DSHEA, the labels of CocoaVia are allowed to say that these supplements “promote a healthy heart by supporting healthy blood flow.”

To convince people to take CocoaVia supplements, Mars funds research.  In 2015, it funded studies demonstrating that cocoa flavanols are well tolerated in healthy men and women,[viii] support healthy cognitive function in aging,[ix] can reverse cardiovascular risk in the healthy elderly,[x] and improve biomarkers of cardiovascular risk.[xi]

Lest the “eat more chocolate” implications of these studies be missed, Mars issued a press release: “Cocoa flavanols lower blood pressure and increase blood vessel function in healthy people.”[xii]  The company followed this announcement with a full-page ad in the New York Times quoting a dietitian: flavanols “support healthy blood flow…which allows oxygen and nutrients to get to your heart more easily.”  …The ad directed readers to more information on a paid ad on the Times’ Website.  You have to look hard in these ads to discover that Mars owns CocoaVia; the company’s name only appears in barely legible print as part of the trademark.[xiii]

But Mars, which already has funded “more than 150 peer-reviewed scientific papers and [has] approximately 100 patents globally in the field of cocoa flavanols”[xiv] has more ambitious research plans.  In 2014, the company announced that in partnership with the National Heart, Lung, and Blood Institute it would provide “financial infrastructure support “ for an ambitious placebo-controlled, randomized trial of the effects of cocoa flavanols alone or in combination with vitamin supplements, on heart disease and cancer risk in 18,000 men and women over the age of 60.[xv]  The five-year trial, called the Cocoa Supplement and Multivitamin Outcomes Study (COSMOS), has evolved somewhat since then.  It now lists Brigham and Women’s Hospital in Boston as the sponsor, and Mars as a “collaborator” along with the Fred Hutchinson Cancer Research Center in Seattle and Pfizer. NIH seems no longer to be involved.[xvi]

We now have the result of this trial.  Even though cocoa flavanol supplements did not reduce cardiovascular events, Mars got its money’s worth from what must have been a very expensive study.

Tomorrow: a second report from this trial, with surprising results.

References

[i] Mars, Inc.  The history of CocoaVia.  CocoaVia.com

https://www.cocoavia.com/how-we-make-it/history-of-cocoavia

[ii] Vlachojannis J, Erne P, Zimmermann B, Chrubasik-Hausmann S.  The impact of cocoa flavanols on cardiovascular health.  Phytother Res.  2016;30(10):1641-57.

[iii] Andres-LaCueva C, Monagas M, Khan N, et al.  Flavanol and flavonol contents of cocoa powder products: influence of the manufacturing process.  J Agric Food Chem. 2008;56:3111-17.

[iv] Crews WD, Harrison DW, Wright JW.  A double-blind, placebo-controlled, randomized trial of the effects of dark chocolate and cocoa on variables associated with neuropsychological functioning and cardiovascular health: clinical findings from a sample of healthy, cognitively intact older adults.  Am J Clin Nutr. 2008;87(4):872-80.

[v] Meek J.  Chocolate is good for you (or how Mars tried to sell us this as health food).  The Guardian, Dec 23, 2002.

https://www.theguardian.com/uk/2002/dec/23/research.highereducation

[vi] Barrionuevo A.  An apple a day for health?  Mars recommends two bars of chocolate.  NY Times, Oct 31, 2005.

The FDA considers candy bars to be foods labeled with Nutrition Facts panels.  Supplements are labeled with Supplement Fact panels.

[vii] FDA.  Inspections, compliance, enforcement, and criminal investigations.  Warning letter to Mr. John Helferich, Masterfoods USA.  FDA, May 31, 2006.  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2006/ucm075927.htm

[viii] Ottaviani JI, Balz M, Kimball J, et al. Safety and efficacy of cocoa flavanol intake in healthy adults: a randomized, controlled, double-masked trial.  Am J Clin Nutr. 2015;102(6):1425-35.

[ix] Necozione S, Raffaele A, Pistacchio L, et al.  Cocoa flavanol consumption improves cognitive function, blood pressure control, and metabolic profile in elderly subjects: the Cocoa, Cognition, and Aging (CoCoA) Study—a randomized controlled trial  Am J Clin Nutr. 2015; 101:538-48.

[x] Heiss C, Sansone R, Karimi H, et al.  Impact of cocoa flavanol intake on age-dependent vascular stiffness in healthy men: a randomized, controlled, double-masked trial.  Age. 2015;37:56.

[xi] Sansone R, Rodriguez-Mateos A, Heuel J, et al.  Cocoa flavanol intake improves endothelial function and Framingham Risk Score in healthy men and women: a randomised, controlled, double-masked trial: the Flaviola Health Study.  Brit J Nutr. 2015;114(8):1246-55.

[xii] Mars Center for Cocoa Health Science.  Press release: Cocoa flavanols lower blood pressure and increase blood vessel function in healthy people.  MarsCocoaScience.com, Sep 9, 2015.  http://www.marscocoascience.com/news/cocoa-flavanols-lower-blood-pressure-and-increase-blood-vessel-function-in-healthy-people.

[xiii] CocoaVia.  Cocoa’s past and present: a new era for heart health.  NY Times, Sep 27, 2015.  http://paidpost.nytimes.com/cocoavia/cocoas-past-and-present-a-new-era-for-heart-health.html?_r=0

[xiv] Mars Symbioscience.  Explore Mars Symbioscience.  Mars.com.

http://www.mars.com/global/brands/symbioscience

[xv] Mars.  Largest nutritional intervention trial of cocoa flavanols and hearth (sic) health to be launched.  MarsCocoaScience.com, Mar 17, 2014.

http://www.marscocoascience.com/news/largest-nutritional-intervention-trial

[xvi] The trial is registered at COcoa Supplement and Multivitamin Outcomes Study (COSMOS).    ClinicalTrials.gov.

https://clinicaltrials.gov/ct2/show/NCT02422745

[xvii] ASRC (Advertising Self-Regulatory Council).  NAD recommends Mars modify certain claims for CocoaVia cocoa extract.  ASRCReviews.org, Aug 11, 2016.

http://www.asrcreviews.org/nad-recommends-mars-modify-certain-claims-for-cocoavia-cocoa-extract/

This is another example of my seeing the title of a paper and wondering right away who paid for it.  The paper is displayed as a research article, but reads more like an analytical opinion piece.

The paper: Nutritionism in a food policy context: the case of ‘animal protein’.  Frédéric Leroy, Ty Beal, Pablo Gregorini, Graham A. McAuliffe, and Stephan van Vliet. Animal Production Science –   Published online: 21 February 2022

The rationale: Reductionist approaches to food focus on isolated nutritional criteria, ignoring the broader physiological and societal benefits and trade-offs involved…Among our present-day array of issues is the disproportionate stigmatisation of animal-source foods as harmful for human and planetary health.

The problem: “…animal-source foods (reduced to the notion of ‘animal protein’) are represented as an intrinsically harmful food category that needs to be minimised, thereby falsely assuming that ‘proteins’ are nutritionally interchangeable.

The solution: “…we suggest referring to said foods as ‘protein-rich foods’, while acknowledging the expanded pool of non-protein nutrients that they provide and their unique capabilities to support a much broader range of bodily functions. Several essential or otherwise beneficial nutrients are generally more bioavailable in animal-source foods than in plant-source foods.

The overall solution: “A more appropriate way forward would consist of combining and integrating the best of animal and plant solutions to reconnect with wholesome and nourishing diets that are rooted in undervalued benefits such as conviviality and shared traditions, thus steering away from a nutrient-centric dogma.”

Funding: FL acknowledges financial support of the Research Council of the Vrije Universiteit Brussel, including the SRP7 and IOF3017 projects, and in particular the Interdisciplinary Research Program ‘Tradition and naturalness of animal products within a societal context of change’ (IRP11). GM is funded by Soil to Nutrition (S2N), Rothamsted Research’s Institute Strategic Programme supported by UK Research and Innovation (UKRI) and Biotechnology and Biological Sciences Research Council (BBSRC) (BBS/E/C/000I0320). SvV grant support by SvV reports grant support from USDA-NIFA-SARE (2020-38640-31521; 2021-67034-35118), the North Dakota beef commission, the Turner Institute of Ecoagriculture, the Dixon Foundation, and the Greenacres Foundation for projects that link agricultural production systems (including livestock and crops) to the nutritional/metabolite composition of foods and human health. PG and FL acknowledge financial support of the project ‘Grazing for environmental and human health’ funded by the New Zealand Royal Society’s Catalyst Seeding Fund.

Conflicts of interest: FL is a non-remunerated board member of various academic non-profit organisations including the Belgian Association for Meat Science and Technology (President), the Belgian Society for Food Microbiology (Secretary), and the Belgian Nutrition Society. On a non-remunerated basis, he also has a seat in the scientific committee of the Institute Danone Belgium, the Scientific Board of the World Farmers’ Organization, and the Advisory Commission for the ‘Protection of Geographical Denominations and Guaranteed Traditional Specialties for Agricultural Products and Foods’ of the Ministry of the Brussels Capital Region. PG is an Associate Editor of Animal Production Science but was blinded from the peer-review process for this paper. SvV reports financial renumeration for academic talks, but does not accept honoraria, consulting fees, or other personal income from food industry groups/companies. All authors consume omnivorous diets.

Comment: I too am an omnivore, do not disagree with much of it, and could have written a lot of this myself, particularly the concerns about nutritionism (the use of nutrients to stand for the foods that contain them) and the concluding sentence in the Abstract: “Humans do not consume isolated nutrients, they consume foods, and they do so as part of culturally complex dietary patterns that, despite their complexity, need to be carefully considered in food policy making.”

But the purpose of this piece is to defend meat as a nutritious source of protein.

Why feel the need to take this on?

That’s what made me wonder who paid for it and whether authors had ties to the meat industry, which of course they do.

Reference: For research on why and how industry sponsorship can influence opinions and study outcomes, see Unsavory Truth: How Food Companies Skew the Science of What We Eat.

I was sent an email with this message:

Calling your attention to this newly released review article, Animal source foods in healthy, sustainable, and ethical diets – An argument against drastic limitation of livestock in the food system. It was published in the March 2022 edition of Animal and is well worth a read, as it makes a strong case for the role of animal source foods in healthy, environmentally sustainable and ethical diets. See below for “highlights” taken directly from the paper, with the full review attached.

–Animal source foods are seen by some as unhealthy, unsustainable, and unethical.

–Outcomes depend on practical specificities, not on the fact that animals are involved.

–As for any food, the challenge is to promote best practices and limit harm.

     –Well-managed animals contribute to food security, ecological function and livelihoods.

     –Heavy reduction of livestock may lead to a fragile food system and societal damage.

I happen to agree that food animals are essential components of regenerative agriculture systems but there was something about this that triggered my “who paid for this?” question.  Bingo!

Here is the paper’s financial support statement:

FL acknowledges financial support of the Research Council of the Vrije Universiteit Brussel, including the SRP7 and IOF342 projects, and in particular, the Interdisciplinary Research Program “Tradition and naturalness of animal products within a societal context of change” (IRP11). PM acknowledges financial support of the Helsinki Institute of Sustainability (HELSUS) through the project “Understanding pastoralism sustainability through an interdisciplinary lens”. PG and FL acknowledge financial support of the project “Grazing for environmental and human health” funded by the New Zealand Royal Society’s Catalyst Seeding Fund. SvV acknowledges grant support from the North Dakota Beef Association to study the health effects of red meat in relation to diet quality. SvV reports additional grant support from USDA-NIFA-SARE (2020-38640-31521; 2021-67034-35118), the Turner Institute of Ecoagriculture, the DixonFoundation, and the Greenacres Foundation for projects that link agricultural production systems (including livestock and crops) to the nutritional/metabolite composition of foods and human health.

Here are the authors’ conflict of interest declarations:

All authors follow omnivorous diets. FL is a non-remunerated board member of various academic non-profit organisations including the Belgian Association for Meat Science and Technology (president), the Belgian Society for Food Microbiology (secretary), and the Belgian Nutrition Society. On a non-remunerated basis, he also has a seat in the scientific committee of the Institute Danone Belgium, the World’s Farmers Organization, and the Advisory Commission for the “Protection of Geographical Denominations and Guaranteed Traditional Specialties for Agricultural Products and Foods” of the Ministry of the Brussels Capital Region. PM is a non-remunerated member of the Spanish Platform for Extensive Livestock and Pastoralism. SvV reports financial renumeration for academic talks, but does not accept honoraria, consulting fees, or other personal income from food industry groups/companies.

Comment: The authors say much more than is usual about their potential conflicts of interest, either via their personal diets or their professional financial links to the meat industry.  Still, those links exist, as I could predict from the paper’s title.  The role of food animals in health and sustainability is heavily disputed.  Because of its funding and the ties of some of the authors to the meat industry, this study appears less convincing than it might if funded independently and carried out by independed researchers.

Reference: For research on why and how industry sponsorship can influence study outcome, see Unsavory Truth: How Food Companies Skew the Science of What We Eat.

I learned about this one from an article—no, it’s an ad really—in NutraIngredients.com.

Its headline: “Large new study validates krill oil’s heart health benefits.”

Heading the page is this note:

CONTENT PROVIDED BY AKER BIOMARINE SUPERBAKrill Learn More

I clicked on Learn More and got a disclaimer, the first time I have seen something like this:

The following content is provided by an advertiser or created on behalf of an advertiser. It is not written by the NutraIngredients.com editorial team, nor does it necessarily reflect the opinions of NutraIngredients.com.

OK.  Now we know that the entire article is an ad paid for by the maker of the product under discussion.

What about the research?

The study: Effectiveness of a Novel ω-3 Krill Oil Agent in Patients With Severe HypertriglyceridemiaA Randomized Clinical Trial.  Dariush Mozaffarian, MD, DrPH¹; Kevin C. Maki, PhD^2,3; Harold E. Bays, MD⁴; et alFernando Aguilera, MD⁵; Glenn Gould, MD⁶; Robert A. Hegele, MD⁷; Patrick M. Moriarty, MD⁸; Jennifer G. Robinson, MD, MPH⁹; Peilin Shi, PhD¹; Josefina F. Tur, MD¹⁰; Jean-François Lapointe, PhD¹¹; Sarya Aziz, PhD¹¹; Pierre Lemieux, PhD¹¹; for the TRILOGY (Study of CaPre in Lowering Very High Triglycerides) investigators.  JAMA Netw Open. 2022;5(1):e2141898. doi:10.1001/jamanetworkopen.2021.41898

Method: The investigators pooled data from two previous trials of people given Krill oil or a cornstarch placebo for 26 weeks.

Results: “This study found that ω-3 –PL/FFA, a novel krill oil–derived ω-3 formulation, reduced TG levels and was safe and well tolerated in patients with severe hypertriglyceridemia.”

Funding/Support:The study was sponsored by Acasti Pharma Inc. [Acasti partners with Aker to make Krill oil]

Role of the Funder/Sponsor: The sponsor collaborated with the academic principal investigator (Dr Mozaffarian) in the design and conduct of the study, interpretation of the data, and review and suggestions for editing of the manuscript. The sponsor collaborated with the academic principal investigator and an independent contract research organization (IQVIA) in study implementation, data collection, and management. The sponsor had no role in the analysis of the data or the decision to submit the manuscript for publication.

Conflict of Interest Disclosures: Dr Mozaffarian reported serving as a consultant for Acasti Pharma Inc as principal investigator of this trial; receiving research funding from the National Institutes of Health, the Gates Foundation, and the Rockefeller Foundation; personal fees from Barilla, Cleveland Clinic Foundation, Danone SA, and Motif FoodWorks; chapter royalties from UpToDate; serving on the scientific advisory board of Beren Therapeutics PBC, Brightseed, Calibrate, DayTwo (ended June 2020), Elysium Health, Filtricine Inc, Foodome Inc, HumanCo, January, Perfect Day Inc, Season, and Tiny Organics; and holding stock ownership in Calibrate and HumanCo outside the submitted work. Dr Maki reported receiving research grants from and consulting for Acasti Pharma Inc and Matinas BioPharma Holdings Inc, and receiving research funding from Indiana University Foundation, Pharmavite, Novo Nordisk A/S, General Mills Inc, The Kellogg Company, and PepsiCo Inc, and consulting for 89bio Inc, and NewAmsterdam Pharma outside the submitted work. Dr Bays reported receiving research grants from Acasti Pharma Inc. Dr Aguilera reported receiving research grants from Acasti Pharma Inc. Dr Gould reported receiving research grants from Acasti Pharma Inc. Dr Hegele reported receiving research grants from Acasti Pharma Inc and personal fees from Akcea-Ionis, Amgen Inc, Arrowhead Pharmaceuticals, HLS Therapeutics Inc, Novartis International AG, and Pfizer Inc outside the submitted work. Dr Moriarty reported receiving research grants from Acasti Pharma Inc. Dr Robinson reported receiving research grants to the institution from Acasti Pharma Inc, Amarin Corporation, Amgen Inc, Astra-Zeneca, Eli Lilly & Co, Esperion Therapeutics Inc, The Medicines Company, Merck & Co Inc, Novartis International AG, Novo Nordisk A/S, and Regeneron Pharmaceuticals Inc, and consulting fees from COR2ED, Getz Pharma Limited, The Medicines Company, and Novartis International AG. Dr Shi reported consulting for Acasti Pharma Inc for performing statistical analyses on this trial. Dr Tur reported receiving research grants from Acasti Pharma Inc. Dr Lapointe reported owning stock or stock options in Acasti Pharma Inc. Dr Aziz reported owning stock or stock options in Acasti Pharma Inc. Dr Lemieux reported serving chief operating officer/chief strategy officer of Acasti Pharma Inc during the conduct of the study and outside the submitted work and holding a patent for CaPre. No other disclosures were reported. [My emphasis]

Comment: You can’t make this stuff up.

Reference: For research on why and how industry sponsorship can influence study outcome, see Unsavory Truth: How Food Companies Skew the Science of What We Eat.

Tara Kenny, a postdoctoral researcher in Ireland sent me this one.

The paper: Perspective Nutrition research challenges and processed food and health. Michael J. Gibney and Ciarán Forde. Nature Food, 2022.

Purpose: “If public health nutrition is to consider the degree of food processing as an important element of the link between food and health, certain gaps in research must be acknowledged.”

Method: The paper compares and critiques differing classification systems for processed foods, emphasizes the physical and sensory aspects of food products as reasons for consumption, and suggests areas for further research.

Conclusion: “The NOVA recommendation that HPFs be avoided poses a considerable challenge, given that a wide body of evidence across the globe shows that almost two-thirds of all energy comes from HPFs…Finally, notwithstanding the opposition of NOVA to the reformulation of HPFs, the value of this approach is internationally recognized.”

Competing interests: “M.J.G. has engaged in paid and non-paid consultancy for a wide range of food companies that manufacture processed foods. He has provided online presentations on ultraprocessed foods to the staff of Unilever and Mondelez. C.G.F. is currently a paid member of the Kerry Health and Nutrition Institute.”

Comment: The paper is a critique of the term ultra-processed (the authors prefer Highly Processed Foods or HPF), of the NOVA classification system for levels of food processing, and of the idea that ultra-processed foods continue to remain in the category of ultra-processed even when reformulated.

Dr. Kenny provided a deeper analysis of the conflicts of interest inherent in this paper; she read the references to several statements in the paragraph that follows the subtitle, “First, do no harm”.

• Ample evidence exists to show that there are no differences in postprandial glucose or insulin response following the ingestion of breads, varying from wholegrain to white and to those with and without additives (Breen et al & Gibney, MRC Human Nutrition Research, Government Agency)
• Similarly, studies show that the nutrient intakes of infants fed on home-prepared infant and toddler foods are not materially different to those of infants fed on industrially prepared products with the exception of sodium, which was higher in the infants fed with home-prepared foods (Reidy et al, 2018 – lead author is head of Nutrition Science for Baby Food, Nestlé Infant Nutrition, Global R&D and leads the Feeding Infants and Toddlers Studies globally. Three additional authors are also Nestle employees).
• Breakfast cereals, normally served with milk, make a very important contribution to micronutrient intake (Gibney et al, 2018 – funded by Cereal Partners Worldwide and General Mills Inc.)
• The advent of low-fat spreads optimized for fatty-acid profile have contributed to a substantial reduction in the intake of saturated fatty acids (Li et al & Gibney).
• Beverages sweetened with artificial sweeteners help reduce the intake of added sugars. These filters should also include foods that are generally regarded as ‘treats’ that have a negligible population impact on nutrient intake (for example, ice cream and chocolate). For example, a study of chocolate intake in 11 European countries showed that the contribution of chocolate to added sugar intake averaged 5% (Azaïs-Braesco et al, funded by Danone Nutricia Research)…”.

She also provided a link to a much more detailed conflict-of-interest statement filed as a correction to another paper co-authored by Mike Gibney.

I’ve written frequently about ultra-processed foods and why I think the NOVA classification is so useful.  See, for example, this post (the classification system) and this one (Kevin Hall’s study).

Despite the opinions expressed in the Nature Food paper, reducing intake of ultra-processed foods seems like a really good idea.