Currently browsing posts about: Conflicts-of-interest

NutraIngredients, a newsletter I read daily, caught my eye with this headline:

Blueberries benefit postmenopausal women with high blood pressure: Study:  Daily blueberry consumption improves endothelial function in postmenopausal women with high blood pressure, according to a recent study…. Read more

I looked it up, of course.

• The study: Daily blueberry consumption for 12 weeks improves endothelial function in postmenopausal women with above-normal blood pressure through reductions in oxidative stress: a randomized controlled trial. Food Funct., 2023,14, 2621-2641
• Objective: “to examine the efficacy of blueberries to improve endothelial function and blood pressure in postmenopausal women with above-normal blood pressure, and to identify potential mechanisms for improvements in endothelial function.”
• Method: Postmenopausal women with elevated blood pressure or hypertension were given 22 g/day of freeze-dried highbush blueberry powder or placebo powder for 12 weeks.
• Findings: The sum of plasma (poly)phenol metabolites increased in the blueberry group compared to baseline, and were higher than the placebo group.  Increases in several plasma flavonoid and microbial metabolites were also noted. No major differences were found for blood pressure, arterial stiffness, blood biomarkers, or endothelial cell protein expression following blueberry consumption (my emphasis).
• Conclusion: “These findings suggest daily consumption of freeze-dried blueberry powder for 12 weeks improves endothelial function through reduced oxidative stress in postmenopausal women with above-normal blood pressure”
• Conflicts of interest: There are no conflicts to declare.
• Acknowledgements: This research was funded by the US Highbush Blueberry Council, the USDA National Institute of Food and Agriculture [Grant No. 2020-67017-30833/Project Accession No. 1021875], and the College of Health and Human Sciences at Colorado State University.

Comment: Yes there is a conflict of interest, but the authors don’t seem to recognize it.  This is a classic case of interpretation bias; the study didn’t show much of anything but the authors conclude that blueberry powder does some good.

High marks to NutraIngredients for disclosing the funding source right at the top of the article:

Published in the journal Food and Function, the study was supported by the US Highbush Blueberry Council and the USDA National Institute of Food and Agriculture.

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I give high praise to NutraIngredients.com for doing full disclosure in the title of an article: “Industry study concludes whey promotes muscular strength and endurance, independent of diet.”

Whey protein supplementation promotes muscle mass increase and selective increases in muscular strength and endurance from resistance exercise, independent of dietary influence, according to a new industry-funded study.

I looked up the study.

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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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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My theme for this week is meat, poultry, and their alternatives, starting today with this:

The study: 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, nqac152, https://doi.org/10.1093/ajcn/nqac152.  

Objectives: “We sought to investigate the effects of healthy diets that include small or large amounts of red meat on the maintenance of lost weight after successful weight loss….”