Currently browsing posts about: Sponsored-research

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.

This study, produced by Tate & Lyle, was sent to me by a reader, but Tate & Lyle also sent me:

• A press release: “Fibre fortification could lower risk of heart disease and diabetes for 7 in 10 UK adults.”
• An infographic with the results of the study: “Benefits of Reformulating with Fibre.”

The press release worked.  FoodNavigator.com did a story with this headline: “Fibre fortification in everyday foods could lower risk of heart disease and diabetes”

A new study suggests that adding fibre to everyday foods – including baked foods, dairy products, soups, smoothies and dressings – would allow 50% more UK adults to reach their recommended daily consumption of fibre. This could in turn lower the risk of heart disease and diabetes.

I give FoodNavigator.com high marks for stating right up front who paid for this study:

New research from ingredie3nt supplier Tate & Lyle, published in Cambridge University Press’ British Journal of Nutrition, found reformulating everyday foods with added fibre could reduce the risk of cardiovascular disease and type 2 diabetes for 72% of the UK adult population.

The study: Estimating the potential public health impact of fibre enrichment: a UK modelling study.  Kirstie Canene-Adams, Ieva Laurie, Kavita Karnik, et al.  Br J Nutr. 2022 Jan 7;1-7.   doi: 10.1017/S0007114521004827. Online ahead of print.

Conclusions: The fibre enrichment intervention showed a mean fibre intake of 19·9 g/d in the UK, signifying a 2·2 g/d increase from baseline. Modelling suggested that 5·9 % of subjects could achieve a weight reduction, 72·2 % a reduction in cardiovascular risk and 71·7 % a reduced risk of type 2 diabetes with fibre fortification (all Ps ≤ 0·05).

Conflict of Interest statement: Authors are employees of Tate & Lyle PLC (IL and KK) or Creme Global (BF, WG, SP) as indicated by our affiliations. KCA was employed by Tate & Lyle PLC at the time of research and writing the article and is now employed by Mars Wrigley. This work was funded by Tate & Lyle, London, UK which specialises in fibres and low-calorie sweetening ingredients used by food and drink producers worldwide. Creme Global is a company based in Dublin, Ireland which specialises in scientific modelling in the areas of food, nutrition and cosmetics.

Comment: Tate & Lyle collected data on what consumers currently eat and drink using the UK’s National Diet and Nutrition Survey.  Investigators applied statistical models to determine how fiber-supplemented food would change consumers’ diet and health.

My translation: Tate & Lyle employees added fiber to foods, predicted that if people ate foods with added fiber they would take in more fiber (duh), and found just that.

Tate & Lyle makes fiber supplements.  Are Tate & Lyle fiber supplements as good for health as the fiber found naturally in food?  That, alas, is beyond the scope of a modeling study.

Addition

Hugh Joseph sent along this video from Tate & Lyle.  It’s about all the good things T&L ingredients do for Jane’s diet.  Oh dear.

I am indebted to David Ludwig for passing along this bit of nutritional history.

The study: PROLONGED MEAT DIETS WITH A STUDY OF KIDNEY FUNCTION AND KETOSIS.*
BY WALTERS. McCLELLAN AND EUGENE F. Du BOIS.  Journal of Biological Chemistry Volume 87, Issue 3, 1 July 1930, Pages 651-668
Method:  Several men agreed to eat nothing but meat for a year.  The meats included beef, lamb, veal, pork, and chicken, in various parts.  This was a high-fat, low-carb diet.  The men lived at home mostly.

Conclusion: In these trained subjects, the clinical observations and laboratory studies gave no evidence that any ill effects had occurred from the prolonged use of the exclusive meat diet.

Funder: These studies were supported in part by a research grant from the Institute of American Meat Packers.

Comment: I did not realize that industry sponsorship of favorable studies went back that far.  I’ll bet there are lots more.  Researchers: start digging!

Members of the Academy of Nutrition and Dietetics get SmartBriefs sent to their email addresses.

The subject line of this one: “A Surprising Sodium Reduction Tool for Your Clients”

It is an advertisement; it even says so.  But it does not say who paid for it.

To find that out, you have to click on the subscribe or resource links.

Bingo!  Ajnomoto, the maker of MSG.

All of this is to convince dietitians to push MSG as a salt substitute:

 Extensive research has affirmed not only the ingredient’s safety, but its benefits for sodium reduction. Even the National Academies of Sciences, Engineering and Medicine has recognized MSG as a tool to reduce sodium in the food supply.

Is this a good or bad idea?  MSG still has sodium and its health effects remain under debate.

This kind of sponsorship should be disclosed, front and center, in ads like this, especially because much of the research demonstrating benefits of MSG was funded by guess which company.

The Academy of Nutrition and Dietetics should not permit ads that lack full disclosure.

Members: Complain to the Academy that you want these ads to stop.

Thanks to Jackie Bertoldo for alerting me to this one.

Thanks to Daniel Bowman Simon for pointing me to this one.

The study: Effect of Standardized Grape Powder Consumption on the Gut Microbiome of Healthy Subjects: A Pilot Study.  Jieping Yang, et al.  Nutrients. 2021 Nov; 13(11): 3965. doi: 10.3390/nu13113965

Methods: Study subjects had to eat 46 grams a day of grape powder (the equivalent of two daily grape servings) for 4 weeks.  Their microbiomes and serum cholesterol levels were compared to those observed during a baseline 4-week period.

Conclusions: “In conclusion, grape powder consumption significantly modified the gut microbiome and cholesterol/bile acid metabolism.”

Funding: This research was funded by California Table Grape Commission.

Conflicts of Interest: No potential conflict of interest was reported by the authors.

Comment: The authors see no conflicts of interest but they accepted funding from the Grape Commission for the study.  California grape producers issue requests for research proposals to demonstrate the health benefits of grapes using grape powder, so I’m guessing the authors applied for this funding.  As I explain in my book, Unsavory Truth, industry influence on research outcome is well documented, but often unrecognized by recipients.  Funders typically get what they pay for.  Does grape powder duplicate the nutritional benefits of grapes?  Hard to say.  Are any of these results clinically important?  Ditto.

Two studies of the role of nuts in health.

I.  This one comes from ObesityandEnergetics.org’s “Headline vs. Study.”

Headline: Maximum Wellness: Walnuts are a Life-Extension Food:  “Looks like your [sic] nuts not to include walnuts in your diet. For more information and to read this study…go to maxwellnutrition.com, where you can find top wellness and nutrition products made in the United States – shipped to your door.”  [Comment: Clearly, we are dealing here with marketing]

Study: Association of Self-Reported Walnut Consumption with Total and Cause-Specific Mortality and Life Expectancy in U.S. Adults. Maximum Wellness nor Causation Necessarily Established.  Liu, X.; Guasch-Ferré, M.; Tobias, D.K.; Li, Y.  Nutrients 2021, 13, 2699. https://doi.org/ 10.3390/nu13082699

Conclusion: A greater life expectancy at age 60 (1.30 years in women and 1.26 years in men) was observed among those who consumed walnuts more than 5 servings/week compared to non-consumers.  Higher walnut consumption was associated with a lower risk of total and CVD mortality and a greater gained life expectancy among U.S. elder adults.  [Comment: association, not causation, and the difference is small].

Conflict of interest: The last (senior?) author reports having received research support from California Walnut Commission, but states that ” The funder has no role in the design and conduct of the study, in the collection, analysis, and interpretation of the data, and in the preparation, review, or in the decision to publish the results.”  [Comment: That’s what they all say, but research often demonstrates otherwise, as I review in my book Unsavory Truth].

And now for the second:

II.  Association of nut consumption with risk of total cancer and 5 specific cancers: evidence from 3 large prospective cohort studies.  Zhe Fang, You Wu, Yanping Li, Xuehong Zhang, Walter C Willett, A Heather Eliassen,1Bernard Rosner,
Mingyang Song, Lorelei A Mucci,and Edward L Giovannucci.  The American Journal of Clinical Nutrition, Volume 114, Issue 6, December 2021, Pages 1925–1935, https://doi.org/10.1093/ajcn/nqab295

Conclusion: In 3 large prospective cohorts, frequent nut consumption was not associated with risk of total cancer and common individual cancers.  [Comment: What? An industry-funded study that finds no benefuts?]

Funding: Supported by the California Walnut Commission and Swiss Re Management Ltd (to YL),… and NIH grants U01 CA167552 (to LAM and the Health Professionals Follow-up Study), UM1 CA186107 and P01 CA87969 (to the Nurses’ Health Study), and U01 CA176726 (to AHE and the Nurses’ Health Study II). The funding sources did not participate in the study design; or
collection, analysis, or interpretation of the data; or preparation, review, or approval of the manuscript.

Here’s how the authors explain their highly unusual no-benefit result:

Given the scarcity of available high-quality data, our findings add to current evidence to more precisely determine the relation between nut consumption and cancer risk. So far, the population based evidence has not been strong enough to conclude that nut consumption is protective against total cancer and these 5 common cancers. Future studies on other cancer sites are still needed to examine the benefits of nuts on cancer development.

Really?  Why?  Do the authors not believe their own data?  Their findings ought to settle the matter and encourage the authors to move on to more significant research.  “More research needed” keeps the California Walnut Commission busy.

Research funded by food companies always requires a degree of skepticism, no matter what the results.

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.