Currently browsing posts about: Sponsored-research

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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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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