Currently browsing posts about: Sponsored-research

I was interested to come across this paper: Conflict of Interests in the Scientific Production on Vitamin D and COVID-19: A Scoping Review.   Front Public Health. 2022 Jul 11;10:821740.   doi: 10.3389/fpubh.2022.821740. eCollection 2022.

Results and conclusions: 

• Studies were funded by companies in the diagnostics, pharmaceutical and food sectors.
• Conclusions favorable to vitamin D supplementation were more prevalent in papers where COI was identified (9/13, 69.2%) than among papers where COI was not found (4/16, 25.0%).
• Omissions of disclosure of COI, funding source, and sponsor functions were observed.
• The identification of possible corporate political activities in scientific papers about vitamin D published during the COVID-19 pandemic signals a need for greater transparency and guideline development on the prevention of COI in scientific production.

Comment:  Not many studies look at disclosure issues this closely.  This is a welcome addition to the genre.  It reminds me of this especially entertaining report: “COVID-19 and misinformation: how an infodemic fuelled the prominence of vitamin D.”  Papers on vitamin D and COVID-19, it seems, are not only influenced by corporate interests; they are also occasionally fraudulent, if viral.

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So many people send me these things that I can hardly keep up.  Let’s take a look at two this time.  Thanks to Hugh Joseph and Matthew Kirby for these:

I.  The impact of almonds and almond processing on gastrointestinal physiology, luminal microbiology, and gastrointestinal symptoms: a randomized controlled trial and mastication study   Alice C Creedon, Eirini Dimidi, Estella S Hung, Megan Rossi, Christopher Probert, Terri Grassby, Jesus Miguens-Blanco, Julian R Marchesi, S Mark Scott, Sarah E Berry, Kevin Whelan.  The American Journal of Clinical Nutrition, Volume 116, Issue 6, December 2022, Pages 1790–1804, https://doi.org/10.1093/ajcn/nqac265

• Conclusions: “Almond consumption has limited impact on microbiota composition but increases butyrate in adults, suggesting positive alterations to microbiota functionality. Almonds can be incorporated into the diet to increase fiber consumption without gut symptoms.”
• Funding: Supported by an Almond Board of California grant (to KW). The funders provided financial support, and the whole and ground almonds consumed by participants in the trial, but had no role in study design, conduct, analysis, interpretation, or decision to publish.
• Author disclosures: ACC was funded by a PhD studentship funded by Almond Board of California. ED has received an education grant from Alpro, research funding from the British Dietetic Association, Almond Board of California, the International Nut and Dried Fruit Council, and Nestec Ltd, and has served as a consultant for Puratos. MR and KW have received research funding from Almond Board of California, Danone, and International Dried Fruit and Nut Council, and are co-inventors of volatile organic compounds in the diagnosis and dietary management of irritable bowel syndrome. MR is also cofounder of Bio&Me, a gut health food brand. TG supervises PhD students partially funded by Mondelez and McCain Foods Ltd, and has previously received research funding from Almond Board of California. SEB has received grant funding from Almond Board of California, Malaysian Palm Oil Board, and ZOE Ltd, and receives consultancy and options from ZOE Ltd. All other authors report no conflicts of interest.
• Comment: The Almond Board is doing its job, apparently.

II. Almond intake alters the acute plasma dihydroxy-octadecenoic acid (DiHOME) response to eccentric exercise.   David C. Nieman^1*,  Ashraf M. Omar²,  Colin D. Kay³,  Deepak M. Kasote³,  Camila A. Sakaguchi¹,  Ankhbayar Lkhagva²,  Mehari Muuz Weldemariam² and  Qibin Zhang. Front. Nutr., 09 January 2023. https://doi.org/10.3389/fnut.2022.1042719

• Conclusions: “These data support some positive effects of almond intake in improving mood state, retaining strength, decreasing muscle damage, increasing the generation of gut-derived phenolic metabolites, and altering the plasma oxylipin DiHOME response to unaccustomed eccentric exercise in untrained adults. The elevated post-exercise plasma levels of 12,13-DiHOME with almond intake support positive metabolic outcomes for adults engaging in unaccustomed eccentric exercise bouts.”
• Funding: “This work was supported by Almond Board of California, Modesto, CA. The funder had no role in the study design, data collection, analysis and interpretation, the preparation of the manuscript, or in the decision to submit the article for publication.”
• Conflict of Interest: “The 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.”
• Comment:  I disagree.  The fact that the Almond Board funded the study if nothing else gives the appearance of conflicted interests, especially because studies so clearly document the influence of funding whether recognized by recipients or not.

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I’m working on a book chapter on pet food and was interested to hear from Phyllis Entis, author of TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, who sent me this.

The study: Isabella Corsato Alvarenga, Amanda N. Dainton & Charles G. Aldrich (2021).  A review: nutrition and process attributes of corn in pet foods, Critical Reviews in Food Science and Nutrition, DOI: 10.1080/10408398.2021.1931020

Background: “Corn is one of the largest cereal crops worldwide and plays an important role in the U.S. economy. The pet food market is growing every year, and although corn is well utilized by dogs, some marketing claims have attributed a negative image to this cereal.”

Purpose:  “the objective of this work was to review the literature regarding corn and its co-products, as well as describe the processing of these ingredients as they pertain to pet foods.”

Findings: “Corn is well digested by both dogs and cats and provides nutrients…In conclusion, the negative perception by some in the pet food market may not be warranted in pet foods using corn and its co-products.”

Conflicted interests: “The authors are with the Department of Grain Science and Industry, Kansas State University, Manhattan, Kansas, USA.”

Funding: “This work was commissioned by the Kansas Corn Commission.”

Comment:  For the record, substantial research supports the ability of dogs and cats to digest and use the nutrients in corn.  This has been documented for a long time.  The purpose of this review is to reassure pet owners that it’s to feed corn-containing products to their dogs and cats.  Corn is the most prevalent ingredient in commercial complete pet foods.   Lots of pet owners believe that grain-free foods are bad for pets and are buying grain-free products.  These must be cutting into sales.  Once again, this is an industry-funded study with predictable results.

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Jim Krieger of Healthy Food America sent me this Food Navigator article titled “Can ultra-processed packaged food play a role in healthy, sustainable diets of the future.”

Uh oh.  Another attack on the concept of ultra-processed foods.  These, you will recall, are strongly associated in observational studies with poor health outcome, and one clinical trial demonstrates them to cause people to eat more calories.

The makers of highly processed foods are understandably worried that the word will get out and people will stop eating them.

Clif Bar to the rescue.

It sponsored a small session to establish guidelines for making highly processed foods healthier: “Making Healthy, Sustainable Diets Accessible and Achievable: A New Framework for Assessing the Nutrition, Environmental, and Equity Impacts of Packaged Foods”

The publication emphasizes flaws in the concept of “ultra-processed,” an approach it says

lacks the nuance needed to holistically evaluate packaged foods within recommended dietary patterns. Additionally, there is considerable diversity of opinion within the literature on these topics, especially on how best to improve nutrition security in populations most at risk of diet-related chronic disease. In support of addressing these challenges, 8 sustainability and nutrition experts were convened by Clif Bar & Company for a facilitated discussion on the urgent need to drive adoption of healthy, sustainable diets; the crucial role that certain packaged foods can play in helping make such diets achievable and accessible; and the need for actionable guidance around how to recommend and choose packaged foods that consider human, societal, and planetary health.

Acknowledgments: “Staff at Clif Bar & Company developed the meeting agenda, synthesized all prework inputs, participated as observers in the workshop, and assisted in the gathering of the materials used to prepare this manuscript.”

Here is an ingredient list for an oatmeal raisin walnut Clif Bar:

ORGANIC ROLLED OATS, ORGANIC BROWN RICE SYRUP, SOY RICE CRISPS (SOY PROTEIN ISOLATE, RICE FLOUR, BARLEY MALT EXTRACT), ORGANIC ROASTED SOYBEANS, ORGANIC TAPIOCA SYRUP, ORGANIC CANE SYRUP, ORGANIC RAISINS, CHICORY FIBER, ORGANIC SOY FLOUR, WALNUTS, SUNFLOWER AND/OR SOYBEAN OIL, NATURAL FLAVORS, SALT, ORGANIC CINNAMON, MIXED TOCOPHEROLS (ANTIOXIDANT).

My definition of ultra-processed is that you can’t make it in your home kitchen because the ingredients are industrially produced and not available in supermarkets.  By this definition, the soy rice crisps are ultra-processed and maybe chicory fiber, but that’s about it.

The Clif people must be worried that they will be viewed in the same category as seriously ultra-processed snack foods.

Let’s give them and their parent company, Mondelez, credit for full disclosure.

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Happy new year to all.!

And now, back to my Monday postings of industry-funded studies.  Today’s is about the popular herbal supplement, ashwagandha.   This is typically taken to reduce stress and improve a wide variety of health problems, but little science backs up those contentions.  Hence, this study, which I learned about from reading an account of it: Single ashwagandha dose may exert cognitive performance: Study.  That headline was all it took to get me to ask my usual question: Who paid for this?

The study: Effects of Acute Ashwagandha Ingestion on Cognitive Function. Int. J. Environ. Res. Public Health 2022, 19(19), 11852; https://doi.org/10.3390/ijerph191911852

Methods: The study assessed performance on the Berg–Wisconsin Card Sorting (BCST), Go/No-Go (GNG), Sternberg Task (STT), and Psychomotor Vigilance Task (PVTT) tests.   Participants took a placebo or ashwagandha (ASH) extract (NooGandha^®, Specnova Inc., Boca Raton, FL, USA).

Conclusions: Acute supplementation with 400 mg of ashwagandha improved selected measures of executive function, helped sustain attention, and increased short-term/working memory.

Funding: “This study was funded as a fee-for-service project awarded to the Human Clinical Research Facility at Texas A&M University from Specnova, Inc. (Boca Raton, FL, USA)…Specnova was not involved in any way in data collection, analysis of the data, or the writing of the manuscript.”

Comment: Specnova, you will not be surprised to learn, is a supplier of supplement ingredients.  The company ordered the study to its specifications.  It got the result it wanted, as funders almost invariably do.  Despite booming sales of ashwagandha, so little is known about its properties that the National Center for Complementary and Integrative Medicine does not even have a fact sheet for it among its reviews of herbal supplements.  Industry-sponsored research to the rescue!  And of course it “was not involved in any way…”  It didn’t have to be.  Funding is usually enough to induce unconscious bias on its own.

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Thanks to Larissa Zimberoff (“Technically Food”) for forwarding this gem of a press release.

Grape Consumption Helps Counter UV Damage to Skin

Recent study reinforces promising role of grapes in photoprotection

A recent human study published in the scientific journal Antioxidants found that consuming grapes protected against ultraviolet (UV) damage to the skin.^[1]  Study subjects showed increased resistance to sunburn after consuming 2 ¼ cups of grapes [sic] every day for two weeks. Additionally, subjects displaying UV resistance also demonstrated unique microbiomic and metabolomic profiles suggesting a correlation between the gut and skin. Natural components found in grapes known as polyphenols are thought to be responsible for these beneficial effects.

The title alone makes me ask: Who paid for this?

Here’s the study: ^[1] Pezzuto, J.M.; Dave, A.; Park, E.-J.; Beyoğlu, D.; Idle, J.R. Short-Term Grape Consumption Diminishes UV-Induced Skin Erythema. Antioxidants 2022, 11, 2372. https://doi.org/10.3390/antiox11122372

Funding: “This work was supported in part by the California Table Grape Commission (J.M.P and J.R.I./D.B.).”  The funding statement continues:

The sponsor was not involved in the preparation of the article; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit this article for publication.

Comment: That’s what they all say, despite much overall evidence to the contrary.

Why the sic?  The study was not, in fact, done wtih grapes.,  It was done with “whole grape powder – equivalent to 2.25 cups of grapes per day – for 14 days.”

Are powdered grapes the same as whole grapes?  Would anyone be willing to eat 2.25 cups of whole grapes every day for 14 days?

I like grapes, and grow two kinds on a fence in Ithaca, some for eating, the Concord ones for jam.  Grapes are fruit.  Fruit is good for health.  Eat them if you like them.  They are useful parts of healthy diets.

Are grapes the only fruit that helps counter UV damage to skin?  I doubt it.  But I’m guessing sunscreens work better.

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As regular readers know, I subscribe to the weekly newsletter, Obesity and Energetics Offerings, and particularly enjoy its section on Headline vs Study.

Here’s a particularly amusing example, which right away triggers my question: Who paid for this?

Headline vs Study

• Headline: Snacking on Almonds Can Help People Reduce Calorie Intake: Study.  
• Press Release: Believe It or ‘Nut’, Almonds Can Help You Cut Calories, Study Finds.  
• Study: “There was no significant difference in total energy intake ([…] p = 0.286) or energy from core ([…] p = 0.860) or discretionary foods ([…] p = 0.158) between [almonds and an isocaloric carbohydrate-rich snack bar].”

Let’s take a look.

Headline: Snacking on Almonds Can Help People Reduce Calorie Intake: Study.

A handful of almonds may be the latest weight loss hack, new research suggests.

A new study from the University of South Australia found that eating 30 to 50 grams of almonds could regulate appetite, leading to less calories consumed each day.

The research, which examined both the hormones that regulate appetite and how almonds could aid in controlling hunger, discovered that the consumption of the nut ultimately led to about 300 fewer calories [sic*]consumed at the following meal.

Press Release: Believe It or ‘Nut’, Almonds Can Help You Cut Calories, Study Finds.

Examining how almonds can affect appetite, researchers found that a snack of 30-50 grams of almonds could help people cut back on the number of kilojoules they consume each day.

Published in the European Journal of Nutrition, the study found that people who consumed almonds — as opposed to an energy-equivalent carbohydrate snack — lowered their energy intake by 300 kilojoules (most of which came from junk food) at the subsequent meal.

Study:  Acute feeding with almonds compared to a carbohydrate-based snack improves appetite-regulating hormones with no effect on self-reported appetite sensations: a randomised controlled trial. Carter, S., Hill, A.M., Buckley, J.D. et al.Eur J Nutr (2022). https://doi.org/10.1007/s00394-022-03027-2

Results: “…Cholecystokinin, ghrelin, glucagon-like peptide-1, leptin and polypeptide YY AUCs were not different between groups. Self-reported appetite ratings and energy intake following the buffet did not differ between groups.”

Conclusion: “More favourable appetite-regulating hormone responses to AL did not translate into better self-reported appetite or reduced short-term energy consumption. Future studies should investigate implications for longer term appetite regulation.”

Funding: “This work was funded by the Almond Board of California. This funding source had no role in the design of this study or the analysis and interpretation of the data.”

Conflict of interest: “AMC has consulted for Nuts for Life (an initiative of the Australian Tree Nut Industry). S-YT has previously been involved in studies funded by the Californian Walnut Commission. AMC, JDB and S-YT have previously been involved in studies funded by International Nut and Dried Fruit Council.”

*Comment: How could the headline get it so wrong?  The authors write: “Although not significant, the AL group consumed 300 kJ less energy in the meal challenge than the SB group, 270 kJ of which came from discretionary foods, which may be a clinically important benefit in weight management.”  The sic partly explains the problem.  The 300 refers to kilojoules (kj), not calories.  300 kj = 72 calories, not 300.  No wonder the result wasn’t statistically significant.

But the press release and resulting headline explain why the nut industry funds studies like this.  Even when the result shows no difference, the PR people can spin the data to produce the expected favorable result.

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Beyond Meat is taking a beating these days, and this study only adds to its  woes.

Assessing the effects of alternative plant-based meats v. animal meats on biomarkers of inflammation: a secondary analysis of the SWAP-MEAT randomized crossover trial.  Crimarco A, Landry MJ, Carter MM, Gardner CD.  J Nutr Sci.  2022;11:e82.  doi:10.1017/jns.2022.84

Abstract: Alternative plant-based meats have grown in popularity with consumers recently and researchers are examining the potential health effects, or risks, from
consuming these products…the purpose of this work was to conduct a secondary analysis of…a randomised crossover trial that involved generally healthy adults eating 2 or more servings of plant-based meats per day for 8 weeks (i.e. Plant phase) followed by 2 or more servings of animal meats per day for 8 weeks (i.e. Animal phase). Results of linear mixed-effects models indicated only 4 out of 92 biomarkers reached statistical significance. The results were contrary to our hypothesis, since we expected relative improvements in biomarkers of inflammation from the plant-based meats.

Conflicts of interest: “Gardner [the senior author] received gift funding from Beyond Meat which was used to conduct the original research study.”

Comment:  This is a follow up to the original research, which I wrote about previously.  That study found a positive result:

A diet that includes an average of two servings of plant-based meat alternatives lowers some cardiovascular risk factors compared with a diet that instead includes the same amount of animal meat…This study found several beneficial effects and no adverse effects from the consumption of plant-based meats.

The investigators tested the effects of substituting Beyond Meat for animal meats on 92 biomarkers of inflammation.  They found hardly any to be improved by the Beyond Meat substitution.

This disappointed the investigators but I’ll bet it disappointed Beyond Meat even more.

This study was not specifically funded by Beyond Meat.

This work was supported by Stanford University’s Precision Health and Integrated Diagnostics Center (PHIND) and in part by a training grant from the NIH National Heart, Lung, and Blood Institute [T32 HL007034].

It is consistent with the overall observation that industry-funded research tends to find results favorable to the sponsor’s interest; independently funded research can go either way.  See my book, Unsavory Truth, for details and references.

Thanks to Stephen Zwick for sending this one.

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