Currently browsing posts about: Sponsored-research

I’m often saying that industry-funded studies tend to produce results that favor the funder’s commercial interests.  This is true, but there are occasional exceptions.

Here, for example, are two studies based on grants from the American Pistachio Growers to the same group of investigators.  Both are randomized clinical trials with results that must have disappointed the funder.

I. Effects of short-term pistachio consumption before and throughout recovery from an intense exercise bout on cardiometabolic markers

Results: Two weeks of pistachio consumption failed to elicit changes in any biomarker (p < .05).. .Overall, in healthy young men with normal blood lipid and glucose metabolism, little effect of either pistachios or intense exercise on cardiometabolic risk indicators was detected.

II. Influence of pistachios on force production, subjective ratings of pain, and oxidative stress following exercise-induced muscle damage in moderately trained athletes: A randomized, crossover trial.

Results: Creatine kinase, myoglobin, and C-reactive protein increased over time following exercise (p < 0.05); however, there were no advantages following pistachio consumption. No significant changes in vertical jump or superoxide dismutase were elicited during any trial.

Comment:  The second paper put a positive spin on the basically null results: “This study demonstrates that 3.0 oz/d of pistachios can reduce delayed onset of muscle soreness and maintain muscle strength, potentially promoting exercise tolerance and training adaptations.”  My question is why anyone would think that pistachios would make any difference anyway.  They are one food in the diets of people who eat many othere kinds of foods.  I’m all for eating pistachios, if you like them, along with lots of other healthy foods.  There is only one reason to do this kind of one-food research—for marketing purposes.

You don’t believe this?  Check out the nutrition and health section of the Pistachio Growers website.  You can’t make this stuff up.

Hey.  If that’s all it takes, give it a try (I guess).

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I always enjoy the Headline vs Study section of the newsletter, Obesity and Energetics Offerings.

• Headline: Healthy New Brain Food for Stressed University Students.
• RCT: No Significant Walnut-Versus-Control Effects Reported for the Primary 16-Week Outcomes of Profile of Mood States (POMS), Salivary Cortisol, or Brain-Derived Neurotrophic Factor.
• Trial Registration: The Effects of Walnuts on General Well­being and Mood Related Factors in a Sample of University Students.

I particularly like this one because the headline says one thing but the study says another, and the authors put a positive spin on the results (interpretation bias).

The study: The Effects of Walnuts and Academic Stress on Mental Health, General Well-Being and the Gut Microbiota in a Sample of University Students: A Randomised Clinical Trial.  Nutrients 2022, 14(22), 4776; https://doi.org/10.3390/nu14224776

Rationale: Poorer mental health is common in undergraduate students due to academic stress. An interplay between stress and diet exists, with stress influencing food choices.

Results: Academic stress was associated with lower gut microbial diversity in females, which was improved by walnut consumption.  The effects of academic stress or walnut consumption in male participants could not be established due to small numbers of participants. Thus, walnut consumption may have a protective effect against some of the negative impacts of academic stress, however sex-dependent mechanisms require further study.

Overall conclusion: While daily consumption of walnuts could not alleviate disturbances in mood, it had a protective effect against the negative impacts of academic stress on mental health…daily walnut consumption over 16 weeks was able to alleviate the negative effects of academic stress on the diversity of the gut microbiota in females, however the relevance of these changes to the biochemistry of chronic stressors such as academic stress requires further study.

Funding: This research was co-funded by the University of South Australia (UniSA) and the California Walnuts Board & Commission…Walnuts for the study participants were provided by the California Walnuts Board & Commission. ..We thank Walnuts Australia for providing walnuts to the control group (upon completion of the study)….

Conflicts of interest: The sponsors had no role in the design, execution, interpretation, or writing of the study. The authors declare no conflict of interest.

Comment: The study didn’t show much, despite the enormous amount of work that went into it.  This looks like an excellent example of interpretation bias—putting a positive spin on barely significant results.  Industry-funded research usuall gets interpreted positively and recipients of industry funding believe that it does not influence them or cause conflicted interests.  But much research says it does.  And then, of course, this is a study of the effects of one food, usually not eaten in large amounts (nuts are expensive!) in diets containing large numbers of other foods.  Attributing big health effects to any one food hardly ever makes sense.

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The study: The Effect of Watermelon Juice Supplementation on Heart Rate Variability and Metabolic Response during an Oral Glucose Challenge: A Randomized, Double-Blind, Placebo-Controlled Crossover Trial.

Methods:  This was a two-week controlled clinical trial to measure the effects of watermelon juice on responses to oral glucose challenge tests in healthy young adults.  These usually decrease heart rate variability (not good).

Results: Watermelon juice countered the reduction in heart rate variability.

Funding: “This research was funded by the National Watermelon Promotional Board.”

Comment: I learned about this study from an article in NutraIngredients-USA: “Watermelon juice may decrease dysfunctsion linked to hyperglycemic episodes.” That headline made me ask my usual question: Who paid for this?  Bingo.

I give NutraIngredients much credit for the funding reveal right after the first paragraph, and for its clear explanation of a complicated study rationale and design.

The authors say they have no conflicts of interest to declare.  I continue to believe that the funding source establishes an automatic conflict of interest.

Once again, as I discuss in detail in my book, Unsavory Truth, the key point about industry-funded studies is that funding recipients do not recognize the influence or the conflict.

But what a coincidence that industry-funded studies so often come out with results favorable to the sponsor’s commercial interest, which in this case is this: The National Watermelon Promotional Board “operates with a single objective: to increase consumer demand for watermelon through promotion, research, and educational programs.”

Unprocessed red meat in the dietary treatment of obesity: a randomized controlled trial of beef supplementation during weight maintenance after successful weight loss.  Faidon Magkos, Sidse I Rasmussen, Mads F Hjorth, Sarah Asping, Maria I Rosenkrans, Anders M Sjödin, Arne V Astrup, Nina R W Geiker. The American Journal of Clinical Nutrition, Volume 116, Issue 6, December 2022, Pages 1820–1830, https://doi.org/10.1093/ajcn/nqac152

Methods: In this 5-mo parallel randomized intervention trial, 108 adults with BMI 28–40 kg/m² (45 males/63 females) underwent an 8-wk rapid weight loss period, and those who lost ≥8% body weight (n = 80) continued to ad libitum weight maintenance diets for 12 wk: a moderate-protein diet with 25 g beef/d (B25, n = 45) or a high-protein diet with 150 g beef/d (B150, n = 35).

Conclusions: Healthy diets consumed ad libitum that contain a little or a lot of unprocessed beef have similar effects on body weight, energy metabolism, and cardiovascular risk factors during the first 3 mo after clinically significant rapid weight loss.

Funding: The study was supported by The Beef Checkoff (a program of the National Cattlemen’s Beef Association, CO, USA) and the Danish Agriculture & Food Council (Copenhagen, Denmark). Lighter Life (Essex, UK) sponsored very-low-calorie diet products for the weight-loss phase of the study. The sponsors had no role in study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the article for publication.

Conflicts of interest: NRWG has received funding from The Beef Checkoff program (National Cattlemen’s Beef Association, CO, USA) and the Danish Agriculture & Food Council (Copenhagen, Denmark) to conduct additional studies relevant to the role of meat in the diet. AVA is a member of the scientific advisory board for Weight Watchers, USA; congressional chairman for RNCP (Répertoire National des Certifications Professionnelles), France; co-owner of the University of Copenhagen spin-off Flax-Slim ApS; co-inventor on a pending provisional patent application for the use of biomarkers to predict responses to weight-loss diets; and co-inventor of other related patents and patent applications that are all owned by the University of Copenhagen, in accordance with Danish law. All other authors report no conflicts of interest.

Comment: The conclusion of this beef industry-funded study is that you can eat as much beef as you like without its having any effect on your body weight or metabolic risk factors, as long as you first lose weight and keep it off.  This is a perfect example of why looking at one food at a time makes no sense without also taking into consideration everything else you are eating and how much.  The Beef Checkoff got the answer it wanted, so money well spent.

Astaxanthin is the dye used by growers of farmed salmon to give the fish a pink color.  They do this by matching the desired amount of the dye to this SalmoFan template.

Astaxanthin, claim its makers, is an antioxidant and, therefore, good for you.

First the public relations: Screen shot: Astaxanthin reduces work-induced visual stress in people aged over 40 – BGG trial: Astaxanthin supplementation has been found to reduce visual display terminal (VDT) work-induced visual stress in people aged over 40, according to a new Japan trial sponsored by supplier BGG Japan. Read more

As for the actual research:

The study: Effects of diet containing astaxanthin on visual function in healthy individuals: a randomized, double-blind, placebo-controlled, parallel study.  Takahiro Sekikawa, Yuki Kizawa, Yanmei Li, Naoki Miura. J Clin Biochem Nutr.  https://doi.org/10.3164/jcbn.22-65.

Results:  In participants aged ≥40 years, corrected visual acuity of the dominant eye after visual display terminal work at 6 weeks after intake demonstrated a higher protective effect of astaxanthin in the astaxanthin group vs the control group (p<0.05). In participants aged <40 years, no significant difference was seen between the astaxanthin and control groups. Moreover, no significant difference was found in functional visual acuity and pupil constriction rate between the astaxanthin and control groups [my emphasis].

Conclusion: These results suggest astaxanthin reduces oxidative stress caused by visual display terminal work. Age-related reduction in ciliary muscle strength is likely the main detractor of visual acuity. Correspondingly, astaxanthin reduced visual display terminal work-induced visual stress in the middleaged and elderly.

Conflict of interest: This trial was sponsored by BGG Japan Co., Ltd., which provided all costs for the implementation of the trial. TS and YK are employees of BGG Japan Co., Ltd. YL is an employee of Beijing Gingko-Group Biological Technology Co., Ltd., which belongs to the same company group as BGG Japan Co., Ltd. NM received funding from BGG Japan Co., Ltd. to provide medical services to the trial participants.

Comment: BGG makes astaxanthin products.  This is a company-sponsored study conducted by researchers employed or paid by the company.  It is an excellent example of interpretation bias—putting a positive spin on results that are marginally significant in some groups but not others, or null.

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I saw this on NutraIngredients.com, one of those newsletters I read regularly: Study: Mulberry extract shrinks blood sugar spike by 40%.  

That headline was all I needed: Who paid for this?

Fortunately, the study was readily available: Mulberry leaf extract improves glycaemic response and insulaemic response to sucrose in healthy subjects: results of a randomized, double blind, placebo‑controlled study.  Pariyarath Sangeetha Thondre Helen Lightowler, Lis Ahlstrom,  Andrew Gallagher.  Nutr Metab (Lond). .2021 Apr 15;18(1):41.   doi: 10.1186/s12986-021-00571-2.

Conclusion: “Mulberry leaf extract can be used as part of lifestyle changes that may lead to healthy blood glucose levels.”

Acknowledgements:  The authors would like to thank Dr Chen Xie (CX) and Mrs Hongwen Yu (HY) for technical input during the conceptualization of the study and editorial commentary on the draft publication. CX and HY are both employees of Phynova Group Limited.

Funding: The work in this study was funded by Phynova Group Ltd, a privately held company that is the developer of Reducose® mulberry leaf extract. Phynova was involved in the study design and manuscript preparation but had no role in data collection and analysis.

Competing of interest: AG is an employee of Phynova Group Limited, the funder of the study. He was involved in the development of the product, design of the study and drafting of the manuscript, but was not involved in the collection, analysis or interpretation of data. PST, HL, and LA have declared they have no conflicts of interest.

Comment:  This degree of industry involvement turns this study into industry-funded marketing research, no matter how beautifully the science is conducted.  Please refer to my book, Unsavory Truth, for references to the studies backing up that statement.

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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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