Currently browsing posts about: Conflicts-of-interest

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)

Thanks to everyone who flooded my mailbox with this piece from The Guardian: She was fired after not endorsing Splenda-filled salads to people with diabetes. Why?

According to a lawsuit {Elizabeth] Hanna recently filed against the ADA, the organization – which endorses recipes and food plans on its websiteand on the websites of “partner” food brands – tried to get her to greenlight recipes that she believedflew in the face of the ADA’s mission. These included recipes like a “cucumber and onion salad” made with a third of a cup of Splenda granulated artificial sweetener, “autumnal sheet-pan veggies” with a quarter cup of Splenda monk fruit sweetener and a “cranberry almond spinach salad” with a quarter cup of Splenda monkfruit sweetener.

Guess which company gave more than $1m to the ADA in 2022? Splenda.

I also was sent an email from Georgia Warren, the  Guardian’s Interim membership editor: The link between investigative reporting, some nightmarish recipes and the diabetes epidemic.

Why would a public health charity promote a product that its own science shows contributes to the disease it is fighting? Well, as Neil Barsky reported for us this week, the ADA took more than $1m from Splenda in 2022 – and then fired their chief nutritionist when, according to a lawsuit she recently filed, she refused to sign-off on the Splenda-based recipes that her bosses wanted the ADA to publicly endorse.

Neil – creator of our new series ‘Death by diabetes: America’s preventable epidemic’ – told me…“The ADA has bought into a system that requires them to raise money from corporations to fund their research. I don’t for a second doubt that every single person who works there cares about people with diabetes and wants to do the right thing, but being beholden to these groups distorts your judgment.”

..And what else is pharma funding? The ADA. The organization – whose guidance doctors rely on when treating their diabetes patients – boasts a $100m annual budget. Between 2017 and 2024, pharmaceutical and device manufacturers contributed over $134m to the organization – or roughly 20% of its total funding.

Comment: The ADA has long appeared to be in thrall the the drug industry.  I well remember the talk I gave at one of its annual conventions years ago.  I was one of two speakers about diet and diabetes (the other was a session on the role of sugar in diabetes sponsored by Coca-Cola—truly you can’t make this stuff up).  The other talks, hundreds of them, were about drugs.  At that time, the ADA said virtually nothing about diet on its website.

It’s gotten much better.  Here’s what it says about carbohydrates:

• Try to eat less of these: refined, highly processed carbohydrate foods and those with added sugar. These include sugary drinks like soda, sweet tea and juice, refined grains like white bread, white rice and sugary cereal, and sweets and snack foods like cake, cookies, candy and chips.

And here’s what the ADA says about artificial sweeteners:

It’s also important to know that at this time, there is no clear evidence to suggest that using sugar substitutes will help with managing blood sugar or weight or improving cardiometabolic health in the long run. So here’s the bottom line:

• Sugar substitutes are effective alternatives to sugar for some people, but not a perfect fit for all—it’s a personal choice.
• If you’re looking to reduce your intake of sugar or sugar substitutes, start slowly. For example, start by replacing one soda or juice with water or a no-calorie drink at a time.
• Water will always be a great choice! If you start feeling yourself get bored with just water, you can always spruce it up with fruits or herbs like this sparkling strawberry mint infused water.

And, finally for now, here are the ADA’s corporate sponsors, and its national sponsors.

Conflicted?  Sure looks like it.

I learned about this one from this article:  Prune consumption may prevent bone loss for postmenopausal women.  Dietary supplementation with prunes can have a broad range of effects on immune, inflammatory and oxidative stress markers in postmenopausal women, according to a recent study…. Read more

When I see a headline like this, my first question is , as always, who would pay for something like this?

I went right to the study:  De Souza MJ, Strock NCA, Williams NI, Lee H, Koltun KJ, Rogers C, Ferruzzi MG, Nakatsu CH, Weaver C. Prunes preserve hip bone mineral density in a 12-month randomized controlled trial in postmenopausal women: the Prune Study. Am J Clin Nutr. 2022 Oct 6;116(4):897-910. doi: 10.1093/ajcn/nqac189.

Conclusion: “The results of this investigation provide compelling evidence of the long-term efficacy of daily prune consumption.”

Funding: We thank the California Prune Board (Award Number: 180215) for the funding and prunes and the participants in this study.

Author disclosures: CW and CR are members of the Nutritional Advisory Panel for the California Prune Board. All other authors report no conflict of interest.

Comment: Bingo on this one.  Wouldn’t it be wonderful if all you had to do to prevent bone loss was to eat 5 prunes a day?   Go for it!

I’ve posted several studies sponsored by the blueberry industry , most recently on their effects on menopausal symptoms.  Blueberry trade associations, as I discuss in my book Unsavory Truth: How the Food Industry Skews the Science of What We Eat, led the way in promoting research suggesting this fruit is a “superfood.”

If only.

They are still at it, apparently, but sponsorship does not always guarantee the desired outcome.  Here is a rare exception to the rule that industry-sponsored studies almost invariably give results favorable to the sponsor’s marketing interest.  Let’s give credit where it is due.

• The study:  Chronic and postprandial effect of blueberries on cognitive function, alertness, and mood in participants with metabolic syndrome – results from a six-month, double-blind, randomized controlled trial.  The American Journal of Clinical Nutrition.  Available online 6 February 2024, https://doi.org/10.1016/j.ajcnut.2023.12.006
• Methods: “A double-blind, randomized controlled trial was conducted, assessing the primary effect of consuming freeze-dried blueberry powder, compared against an isocaloric placebo, on cardiometabolic health >6 mo and a 24 h postprandial period (at baseline).”
• Results: “Postprandial self-rated calmness significantly improved after 1 cup of blueberries (P = 0.01; q = 0.04; with an 11.6% improvement compared with baseline between 0 and 24 h for the 1 cup group), but all other mood, sleep, and cognitive function parameters were unaffected after postprandial and 6-mo blueberries.”
• Conclusion: “Although self-rated calmness improved postprandially, and significant cognition-metabolite associations were identified, our data did not support strong cognitive, mood, alertness, or sleep quality improvements in MetS participants after blueberry intervention.”
• Conflict of interest: “AC reports financial support provided by the US Highbush Blueberry Council (USHBC) and Biotechnology and Biological Sciences Research Council (BBSRC, UK). AC and EBR both act as advisors and consultants to the United States Highbush Blueberry Council grant committee. All other authors report no conflicts of interest.”
• Funding: “This work was supported by the United States Highbush Blueberry Council with oversight from the USDA and the Biotechnology and Biological Sciences Research Council (United Kingdom). The funders of this research had no involvement in this publication and have placed no restrictions on the publication of these data.”

Comment: In this instance, the last statement could well be correct (it isn’t always, alas).  I like blueberries but they are not a superfood.  There is no such thing as a superfood.  If you want to eat healthfully, by all means eat fruit—and enjoy the ones you like best.

I learned about this one from a commentary from Yoni Freedhoff, MD: Kimchi: Not Magically Protective Against Weight Gain.

• The study: Association between kimchi consumption and obesity based on BMI and abdominal obesity in Korean adults: a cross-sectional analysis of the Health Examinees study.  BMJ Open.  2024 Jan 30;14(2):e076650.  doi: 10.1136/bmjopen-2023-076650.
• Participants: “This study analysed 115 726 participants aged 40-69 years enrolled in the Health Examinees study in Korea.”
• Results: “In men, total kimchi consumption of 1-3 servings/day was related to a lower prevalence of obesity (OR: 0.875 in 1-2 servings/day and OR: 0.893 in 2-3 servings/day) compared with total kimchi consumption of <1 serving/day. Also, men with the highest baechu kimchi (cabbage kimchi) consumption had 10% lower odds of obesity and abdominal obesity. Participants who consumed kkakdugi (radish kimchi) ≥median were inversely associated with 8% in men and 11% in women with lower odds of abdominal obesity compared with non-consumers, respectively.”
• Conclusions:  “This large cross-sectional study described the association between kimchi consumption and obesity. In conclusion, total kimchi consumption of 1–3 servings/day was shown to be reversely associated with obesity in men. Regarding the type of kimchi, baechu kimchi was associated with a lower prevalence of obesity in men, and kkakdugi was associated with a lower prevalence of abdominal obesity in both men and women. However, since all results showed a ‘J-shaped’ association, excessive consumption suggests the potential for an increase in obesity prevalence. As kimchi is one of the major sources of sodium intake, a moderate amount of kimchi should be recommended for the health benefits of its other components. In addition, further investigation and prospective studies are needed to confirm the relationship between kimchi consumption and obesity.”
• Competing interests: “HJ and SS have no conflicts of interest to declare for this study. Y-RY and SWH are members of the staff at the World Institute of Kimchi.”
• Funding: “This research was supported by grants from the World Institute of Kimchi (KE2201-1) funded by the Ministry of Science and ICT, Republic of Korea.”

Dr. Freedhoff ‘s analysis of the data:

According to the paper, men who reported eating two to three servings of kimchi per day were found to have lower rates of obesity, whereas men who reported eating three to five servings of kimchi per day were not. But these are overlapping groups! Also found was that men consuming more than five servings of kimchi per day have higher rates of obesity. When taken together, these findings do not demonstrate a statistically significant trend of kimchi intake on obesity in men. Whereas in women, things are worse in that the more kimchi reportedly consumed, the more obesity, in a trend that did (just) reach statistical significance.

Comment: Why anyone would expect kimchi (spicy fermented vegetables such as cabbage) to affect obesity one way or the other is beyond me, but the World Institute of Kimchi must want more people to eat it.  Does anyone need an excuse to eat kimchi?  It’s great on its own without needing this kind of claim.  This study is about marketing, not science.