Currently browsing posts about: Sponsored-research

The USDA has just released this summary of food research funding.

This graph clearly indicates what I view as a big problem: government funding for agricultural and food research has been declining since the early 2000s, whereas private funding—meaning corporations and industries—has sharply increased since 2008 or so.

What’s wrong with this picture?

Government funding can support basic research with no obvious commercial implications—science.

Funding by food corporations and industries has one primary purpose: to develop and promote products—marketing.

I’m not opposed to marketing research, as long as it is labeled as such.

The decline in federal funding for food and nutrition research has long-term implications for scientific progress.

We need basic research on agriculture, food, nutrition, and health.

These curves need to be reversed.

Cranberry marketing gets wilder and wilder.  Last week I posted a study of endothelial function paid for by the cranberry industry.

But here’s a study that tops it.  I learned about it from a headline in NutraIngredients.com: Cranberry consumption may boost memory and ward off dementia in elderly, study finds.

Oh come on.  Really?

I went right to it.

The study: Chronic Consumption of Cranberries (Vaccinium macrocarpon) for 12 Weeks Improves Episodic Memory and Regional Brain Perfusion in Healthy Older Adults: A Randomised, Placebo-Controlled, Parallel-Groups Feasibility Study.  Emma Flanagan, Donnie Cameron, Rashed Sobhan, Chloe Wong, Matthew G. Pontifex, Nicole Tosi, Pedro Mena, Daniele Del Rio³, Saber Sami, Arjan Narbad, Michael Müller, Michael Hornberger and David Vauzour.  Front. Nutr., 19 May 2022 | https://doi.org/10.3389/fnut.2022.849902

Design: This was a 12-week randomised placebo-controlled trial of freeze-dried cranberry powder in 60 older adults aged between 50 and 80 years. Investigators measured memory and executive function, did neuroimaging, and took blood samples before and after .

Results: “Cranberry supplementation for 12 weeks was associated with improvements in visual episodic memory in aged participants when compared to placebo.”

Conclusions: “The results of this study indicate that daily cranberry supplementation (equivalent to 1 small cup of cranberries) over a 12-week period improves episodic memory performance and neural functioning.”

Funding: “This research was supported by a Cranberry Institute grant…The Cranberry Institute was not involved in the design, implementation, analysis, and interpretation of the data.”

Conflict of Interest: “DV, MH, MM, and AN received funding from the Cranberry Institute.  The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.”

Publisher’s Note:  “All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.”

Comment: This is the first time I have ever seen a Publisher’s Note like this.  Even the publisher is troubled by the fact that this study is funded by a cranberry industry trade group and the four most senior authors report funding from the group.  Without even getting into whether cranberry powder is equivalent to cranberries, whether anyone can eat cranberries without adding their weight in sugar, or whether any other fruit might have similar effects, we should ask whether it makes any sense at all to think that any one single food could boost memory and prevent dementia in the elderly.

For detailed discussion of how industry funding influences research, and the consequences of such practices, see my book Unsavory Truth: How Food Companies Skew the Science of What We Eat.

The study:  Daily consumption of cranberry improves endothelial function in healthy adults: a double blind randomized controlled trial.  Christian Heiss,  et al.  Food & Function.  2022;7.  DOI https://doi.org/10.1039/D2FO00080F

Objective: To investigate the vascular effects of acute and daily consumption of freeze dried whole cranberry in healthy men and how effects relate to circulating cranberry (poly)phenol metabolites.

Methods: A double-blind, parallel-group, randomized controlled trial was conducted in 45 healthy male adults randomly allocated to 1 month daily consumption of either cranberry (9 g powder solubilized in water equivalent to 100 g of fresh cranberries, 525 mg total (poly)phenols) or control (9 g powder, no (poly)phenols).

Results: Cranberry consumption significantly increased FMD [flow-mediated dilation].

Conclusions: Acute and daily consumption of whole cranberry powder for 1 month improves vascular function in healthy men and this is linked with specific metabolite profiles in plasma.

Funding: This study was funded by the Cranberry Institute and by the Research Committee of the Medical Faculty of Heinrich-Heine University Dusseldorf (grant number 9772574). The authors also acknowledge a Susanne Bunnenberg Heart Foundation grant to Dusseldorf Heart Centre.

Comment: I like cranberries.  Of course I consider them healthy to eat.  All fruits have health benefits.

But cranberry powder?

And cranberries are tart,; they need sugar.  Ocean Spray’s cranberry sauce recipe calls for one cup of sugar added to 12 ounces of cranberries.

Moderation, please!

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?

I like French fries as much as anyone but c’mon; they are hardly a health food.

The Alliance for Potato Research & Education sent me a press release about a new study demonstrating that “adding a daily 300-calorie serving of French fries to one’s typical diet every day for one month does not result in differential short-term weight gain or other biomarker changes associated with impaired blood sugar regulation compared to adding an isocaloric daily serving of almonds.”

The study: French-fried potatoes consumption and energy balance: a randomized controlled trial.  Daniel L Smith, Jr, Rebecca L Hanson, Stephanie L Dickinson, Xiwei Chen, Amy M Goss, John B Cleek, W Timothy Garvey, David B Allison.  The American Journal of Clinical Nutrition, nqac045, https://doi.org/10.1093/ajcn/nqac045

Purpose: “We completed an RCT [randomized controlled trial] testing whether increased daily potato consumption influences energy balance (specifically, fat mass (FM)) compared with calorie-matched almond consumption.”  Participants were given 300 calories a day in either fries (~3 oz) or almonds (~40).

Conclusion: There were no significant differences in FM [fat mass] or in glucoregulatory biomarkers after 30 days of potato consumption versus almonds. Results do not support a causal relationship between increased French fried potato consumption and the negative health outcomes studied.

Funding: This study was supported in part by a grant from the Alliance for Potato Research and Education (APRE) to DBA and DLS, by Core services through NIH grant awards P30DK056336 and P60DK079626 and the donation of study food items by J.R. Simplot Company.

Comment:  I’m not surprised by this result.   Biomarkers depend on everything you eat, not just one food.

The purpose of this study was to take away any guilt you might feel about eating French fries.   The potato alliance got the result it wanted.

 

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/