Currently browsing posts about: Conflicts-of-interest

Nutrients, a journal that requires authors to pay CHF 2900 ($3400) for their articles, does publish the most amazing studies, ostensibly peer-reviewed (I’ve heard mixed things about its process).  This journal is a source for many of my Monday posts, each more creative than the next.

This is a good one. 

Sourdough Bread with Different Fermentation Times: A Randomized Clinical Trial in Subjects with Metabolic Syndrome. Pérez-Vega KA, Sanllorente A, Zomeño M-D, Quindós A, Muñoz-Martínez J, Malcampo M, Aldea-Perona A, Hernáez Á, Lluansí A, Llirós M, et al.. Nutrients. 2024; 16(15):2380. https://doi.org/10.3390/nu16152380

Rationale: The Mediterranean diet, featuring sourdough bread, shows promise in managing metabolic syndrome.

Method: In a double-blind clinical trial, participants randomized to consume either Elias Boulanger^® long-fermentation (48 h) sourdough bread (EBLong) or Elias Boulanger^® short-fermentation (2 h) sourdough bread (EBShort) over a two-month period.

Results. EBShort bread was effective in reducing some inflammation markers.

Conclusion.  The consumption of sourdough bread may offer potential benefits in reducing inflammation markers in individuals with metabolic syndrome; however, longer fermentation times did not show additional benefits.

Conflicts of interest: “I.E. and N.EM. were employees of Elias–Boulanger and received funding from RTC-2017-6467-2 program. They had no role in the collection, analyses, and interpretation of data or in the decision to publish the results. The rest of the authors declare no conflicts of interest.”

Comment: I’ll bet they didn’t.  Sourdough bread is responsible for the benefits of the Mediterranean diet?  That’s news to me.  The bread is healthier if its fermented for a shorter time?  Also news.

The paper does not describe the taste or texture of the bread.

• Ingredients EBLong: whole-grain flour, water, yeast, salt [in other words, real bread].
• Ingredients EBShort: refined wheat flour, water, yeast, salt, wheat gluten, xanthan gum, emulsifier E471, antioxidant E-300 [this is ultra-processed bread].

Thus, the underlying purpose of this study must be to give Elias-Boulanger an excuse to cut down on fermentation time and claim the cheaper, ultra-processed bread is healthier. Count me as dubious, on taste grounds alone.

But isn’t this a great example of marketing research in action?  You can’t make this stuff up.

ADDITION

A reader points out that Nutrients is not alone in requiring Article Processing Charges (APCs) for open-access publication.  Prestigious journals charge much more.

• Nature:  $12,290

• BMJ: £5408 / €6154 / $7159 $7,159 

• Lancet:  $6,000 – $7,000:+

I saw this announcement in Food Navigator: Study: Nutrient dense formula could improve cognition and behaviour in infants.

My immediate question: Who paid for this?

I went right to it.

The study: Schneider N, Hartweg M, O’Regan J, Beauchemin J, Redman L, Hsia DS, Steiner P, Carmichael O, D’Sa V, Deoni S. Impact of a Nutrient Formulation on Longitudinal Myelination, Cognition, and Behavior from Birth to 2 Years: A Randomized Clinical Trial. Nutrients. 2023; 15(20):4439. https://doi.org/10.3390/nu15204439

Conclusions: The results suggest that brain development may be modifiable with brain- and age-relevant nutritional approaches in healthy infants and young children, which may be foundational for later learning outcomes.

Funding: This study received funding from the Société des Produits Nestlé S.A.

Conflicts of Interest: This study received funding from the Société des Produits Nestlé S.A. The funder had the following involvement with the study: study design, study monitoring and oversight, data collection and analysis, decision to publish, and preparation of the manuscript.

Comment: Some of the authors of this study are employed by Nestlé (no relation).  Their disclosure statement is unusually candid: the funder was totally involved in every aspect of the research.  It’s refreshing to see that dislosed.  But the underlying issue still holds: industry-funded reseach all too often produces results favorable to the commercial interests of the funder.

The concern here is that promoting infant formula as better than breast milk is a marketing strategy, as described in reports from the World Health Organization.  And see my previous post on this.

This one was sent to me by a reader: Animal vs. Plant Protein: New Research Suggests That These Protein Sources Are Not Nutritionally Equivalent: Scientists found that two-ounce-equivalents (oz-eq) of animal-based protein foods provide greater essential amino acids (EAA) bioavailability than the same quantity of plant-based protein foods. The study challenges the Dietary Guidelines for Americans (DGAs) which suggest these protein sources are nutritionally equivalent.

I went right to the study: “Effects of Consuming Ounce-Equivalent Portions of Animal- vs. Plant-Based Protein Foods, as Defined by the Dietary Guidelines for Americans on Essential Amino Acids Bioavailability in Young and Older Adults: Two Cross-Over Randomized Controlled Trials” by Gavin Connolly, Joshua L. Hudson, Robert E. Bergia, Eric M. Davis, Austin S. Hartman, Wenbin Zhu, Chad C. Carroll and Wayne W. Campbell, 25 June 2023, Nutrients. DOI: 10.3390/nu15132870

Oh.  It’s in Nutrients, a journal that might as well be called “The Journal of Industry-Funded Research” (authors have to pay for publication of their articles in this journal–2900 Swiss Francs).

The study was designed to demonstrate that protein from animal sources is better than protein from plant sources, immediately raising the question: Who sponsored this study?

Funding: This research was funded by the Pork Checkoff and the American Egg Board—Egg Nutrition Center. The supporting sources had no role in study design; collection, analysis, and interpretation of data; writing of the report; or submission of the report for publication.

Do the authors report conflicts of interest?  Yes, they do:

Conflicts of Interets: When this research was conducted, W.W.C. received research funding from the following organizations: American Egg Board’s Egg Nutrition Center, Beef Checkoff, Pork Checkoff, North Dakota Beef Commission, Barilla Group, Mushroom Council, and the National Chicken Council. C.C.C. received funding from the Beef Checkoff. R.E.B. is currently employed by Archer-Daniels-Midland (ADM); the research presented in this article was conducted in a former role and has no connection with ADM. G.C., J.L.H., E.M.D., A.S.H. and W.Z. declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

I’m not going to bother going through the methods, results, or other details.  The point here is that industry-funded research has a high probability of producing results favorable to the sponsors’ interests, as happened in this instance.  The statement that the sponsors had no role may or may not be true; it’s hard to know without further investigation, but research on this question demonstrates that the statement is not always accurate.  Funding exerts influence, whether recognized by researchers or not.

A reader who wishes to remain anonymous forwarded this email she received from Kristen Hicks-Roof PhD, RDN, LDN, FAND , Director of Human Nutrition·National Pork Board.

Growing Strong: Animal-Source Foods’ Role in Childhood Development and Sustainable Food Systems

Childhood and adolescence are critically important periods for growth and development. These periods are also key for establishing healthy dietary patterns that can influence eating behaviors and health into adulthood.

During these stages, animal-source foods provide critical nutrients — such as high-quality protein, iron, zinc, choline, and B vitamins — that are not easily replaced from other sources.

In this webinar, Dr. Adegbola Adesogan will:

– Present evidence on the role of animal-source foods in childhood development and impact on future health outcomes

– Review how animal-source foods are a source of key nutrients that support health in children and adolescents

The CPE activity application for this webinar is pending review by the Commission on Dietetic Registration (CDR) and approval for 1.0 CPEU.

Comment

Presumably, the CDR will approve this for continuing education credits required for dietetic licensing.  Also presumably, participants will not learn about the polluting effects of Pork CAFOs or the community lawsuits against them for obnoxious odors and other offenses.  Or the way the pork industry fights back against such complaints.  Or the welfare issues about farrowing crates.  Or complaints about Pork Checkoff programs.

As I’ve noted previously, dietitians are able to fulfill all requirements for continuing education credits from industry-funded courses like this one.

Conflict of interest, anyone?

The title of this article triggered my usual question: Who paid for this?  I cannot think of any reason other than marketing this supplement for doing a study like this.

Multi-nutrient supplementation of astaxanthin, vitamin E and grape juice improves episodic memory, cognitive performance – RCT:  A study has found that 12 weeks of multi-nutrient supplementation, comprising astaxanthin, vitamin E and grape juice extract, resulted in improved episodic memory and several biomarkers associated with cognitive health…. Read more

The study: Lopresti AL, Smith SJ, Riggs ML, Major RA, Gibb TG, Wood SM, Hester SN, Knaggs HE. An Examination into the Effects of a Nutraceutical Supplement on Cognition, Stress, Eye Health, and Skin Satisfaction in Adults with Self-Reported Cognitive Complaints: A Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2024; 16(11):1770. https://doi.org/10.3390/nu16111770

Method: adults aged 40 to 70 years with subjective memory complaints were randomized to take a supplement containing vitamin E, astaxanthin, and grape juice extract daily for 12 weeks or a matching placebo.

Outcomes:  Changes in cognitive tasks assessing episodic memory, working memory, and verbal memory., speed of information processing, attention, and self-report measures of memory, stress, and eye and skin health.

Results: “Compared to the placebo, nutritional supplementation was associated with larger improvements in one primary outcome measure comprising episodic memory (p = 0.037), but not for working memory (p = 0.418) or verbal learning (p = 0.841). Findings from secondary and exploratory outcomes demonstrated that the nutraceutical intake was associated with larger improvements in the Everyday Memory Questionnaire (p = 0.022), increased plasma brain-derived neurotrophic factor (p = 0.030), decreased plasma malondialdehyde (p = 0.040), and increased skin carotenoid concentrations (p = 0.006). However, there were no group differences in changes in the remaining outcome measures.”

Conclusions: “The results from this 12-week study provide some support for the cognitive-enhancing effects of a nutraceutical containing astaxanthin, vitamin E, and grape juice extract in adults with self-reported memory complaints. This was demonstrated by improvements in one primary outcome measure (episodic memory) but not working memory or verbal learning.”

It’s been a couple of years since I’m commented on almond-industry research funding, but it remains hard at work.  Sasha Matera-Vatnick sent me a report of this study from Food Technology.  It essentially reproduced the California Almonds’ press release: New Research: Eating Almonds Can Aid in Post-Exercise Recovery.

The study: Witard, O., Siegel, L., Rooney, J., Marjoram, L., Mason, L., Bowles, E., Valente, T., Keulen, V., Helander, C., Rayo, V., Hong, M. Y., Liu, C., Hooshmand, S., & Kern, M. Chronic almond nut snacking alleviates perceived muscle soreness following downhill running but does not improve indices of cardiometabolic health in mildly overweight, middle-aged, adults. Frontiers in Nutrition. 2024 January 8: doi: https://doi.org/10.3389/fnut.2023.1298868

Method: 25 mildly overweight subject used a treadmill for 30 min after 8-weeks of consuming either 57 g/day of whole almonds (ALMOND) or an isocaloric amount (86 g/day) of unsalted pretzels (CONTROL).

I learned about this one from FoodNavigator-Europe.

Ashwagandha has ‘tremendous potential’ for promoting healthy aging: Review:  Ashwagandha could serve as a potent anti-aging ingredient by improving immune system function and acting as an antioxidant, according to a review published in Frontiers in Nutrition…. Read more

This is the kind of headline that makes me ask: “Who paid for this?”

FoodNavigator usually provides references, so I could easily look this one up.

The study: Current insights into transcriptional role(s) for the nutraceutical Withania somnifera in inflammation and aging.  Praful Saha, Saiprasad Ajgaonkar,  Dishant Maniar, Simran Sahare, , Dilip Mehta,  Sujit Nair. Front. Nutr., 03 May 2024. Volume 11 – 2024 | https://doi.org/10.3389/fnut.2024.1370951.

Conclusions: “Management of aging is difficult due to its progressive and irreversible nature, as well as the comorbidities associated with aging. However, the quality of biological aging can be improvised by recent advancements including intervention with nutraceuticals that can modulate the transcriptional activity of different genes implicated in aging and age-related complications…Taken together, given the modulation of key RNA markers in aging and inflammation pathways, there is tremendous potential for harnessing the beneficial effects of Withania for achieving healthy aging.”

Funding: “The author(s) declare that no financial support was received for the research, authorship, and/or publication of this article.”

Conflict of interest: “PS, SA, DMa, SS, DMe, and SN were employed by PhytoVeda Pvt. Ltd. and Viridis Biopharma Pvt. Ltd., Mumbai, India. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision.”

Comment:  I looked up Viridis BioPharma.

Viridis BioPharma is a marketing, manufacturing and research company that deals with active ingredients for the pharmaceutical, nutraceuticals, food and cosmetic industries, medicated dressings and formulations to treat wounds, burns and other novel clinically proven topical formulations.  What drives us is the desire to extend lifespans and, more than that, to extend health and wellbeing at every stage of life.

Employees of this and the other company developed this quite comprehensive review.  The authors state its purpose explicitly.

WS [Withania somnifera] is known for its versatility in treating a range of conditions, such as immunomodulation, rejuvenation, enhancement of cognitive function, inflammation, enhancing concentration, etc. However, a synthetic review exploring its potential role in ameliorating aging and aging-related disorders is currently lacking…This may facilitate the development of various preventive and therapeutic strategies employing WS as a nutraceutical for healthy aging.

Their funding statement is accurate; they weren’t paid particularly to write this article; they are just on salary generally.  And they are members of the editorial board of this journal.  Oh dear.

Here’s what the NIH says about ashwagandha.  It finds some evidence for use but concludes “most studies have been conducted as part of a traditional medical system, so the potential effects of ashwagandha when used as a dietary supplement outside of that approach remain unclear.”

Last week I posted a debate about the health and environmental consequences of eating snakes, mainly because it never occurred to me that anyone would take it seriously.  I thought it was funny.

Shows you what I know.  Busted.

The eating-snakes-is-sustainable position was based on a study that I obviously had not read.

But a reader, Michael Tlusty, did.  He says the paper raises two issues.

His first has to do with the newsletter that posted the story, FoodManufacture.com.  He says:

Nowhere in the story does the reporter link to the actual research paper (Natusch, D., Aust, P.W., Caraguel, C. et al. Python farming as a flexible and efficient form of agricultural food security. Sci Rep 14, 5419 (2024). https://doi.org/10.1038/s41598-024-54874-4) – I see this a lot – why can’t journalists properly acknowledge scientific efforts?

His second is a critique of the study methods.

they compare ectotherm farming of snakes to that of salmon – however, the data for salmon farming comes from 2011 and 1998. There have been significant improvements since then, so they are biasing their analysis to favor the current snake data. Furthermore, I doubt that salmon would be the substitute for snake. Species more like tilapia and carp would be, and these fish can be fed with completely vegetarian diets. So yes while the invasiveness of pythons is a primary con as you point out, the authors inflate the benefit of snake eating relative to other more substitutable foods.

And then comes the kicker—the reason why I am posting this on Monday when I usually post items about conflicted science.

 And in the spirit of your newsletter, in the ethics declaration on the paper, it states “This work was partly funded by an initiative working to better understand snakes used in the leather trade, which is itself partially funded by companies that use snake skins. ” – so this is an attempt to make luxury snake skin items more “palatable” by turning snake farming into a food security argument.

I am always grateful to hear from sharp-eyed readers, even when they catch me violating a firm principle that dates back to my time in molecular biology graduate school: Always read the original paper.  No exceptions.

As I said, busted.

On a lighter note, it turns out eating snakes is a thing (maybe you knew this already?).  According to this week’s New Yorker, it’s a sign of masculinity in Oklahoma.  I commend this article to your attention: How to Eat a Rattlesnake.

Thanks to Jennifer Wilkins for sending it.  She, by the way, has a new Substack: Eat Right Here.

Addition: Can we really eat invasive species into submission? (thanks to Stephen Zwick for sending)