by Marion Nestle

Currently browsing posts about: Supplements

May 20 2024

Industry-sponsored study of the week: ashwagandha

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.”

Tags: Conflicts-of-interest, Sponsored-research, Supplements

Apr 10 2024

Supplement in Japan causes illnesses, deaths

The headline caught my eye: 5 dead and over 100 hospitalized from recalled Japanese health supplements

The supplement is benikoji.

Kobayashi Pharmaceutical had been selling benikoji products for years, with a million packages sold over the past three fiscal years, but a problem crept up with the supplements produced in 2023. Kobayashi Pharmaceutical said it produced 18.5 tons of benikoji last year.

Apparently, the company knew there was a problem but delayed the recall.

What, you may well ask, is benikoji? The answer: Red yeast rice.

Red yeast rice is a well known dietary supplement. it contains lovastatin. Like other statins, it lowers blood cholesterol levels.

Consumer Lab, which tests and evaluates dietary supplements, says,

Red yeast rice can be very effective in lowering elevated levels of cholesterol, as shown in several clinical trials (see What It Does). However, not all red yeast rice supplements contain the amount of lovastatin needed to lower cholesterol, and products normally do not list the amount of lovastatin they contain on their labels.

In its testing, Consumer Lab found the amounts of lovastatin to range from zero to 7.5 mg per two pills. It added:

Of additional concern is that CL found a potential kidney toxin, citrinin, in 30% of products, one of which contained citrinin at a level 65 times the limit allowed in Europe (there is no established limit in the U.S.).

Like other dietary supplements, nobody is minding the store. Nobody makes sure the contents of a supplement reflect what is on the label or that labels are accurate. The FDA says adding lovastatin to red yeast rice, which some manufacturors do, apparently, is illegal in the U.S. But how would you know?

We don’t know what was wrong with the benikoji supplements. The company said it found puberulic acid, which is highly toxic, in the recalled supplements, but investigations are continuing.

No surprise, I am not a fan of dietary supplements. I want those products regulated, investigated, tested, and monitored. Until they are, I’m not touching them.

Tags: Cholesterol, Supplements

Feb 19 2024

Industry-sponsored study of the week: a menstruation supplement

The study: Lactobacillus paragasseri OLL2809 Improves Premenstrual Psychological Symptoms in Healthy Women: A Randomized, Double-Blind, Placebo-Controlled Study. Nutrients. 2023; 15(23):4985. https://doi.org/10.3390/nu15234985

Methods: “This study employed a randomized, placebo-controlled, double-blind, parallel-group design to assess the efficacy of continuous ingestion of OLL2809 [the supplement] for managing menstrual symptoms in healthy women.”

Conclusion: “This study suggests that the consumption of OLL2809 over three menstrual cycles in healthy women can alleviate premenstrual ‘decline in activity’ and ‘irritability’, thereby indicating the potential of OLL2809 to enhance women’s QOL [Quality of Life].

Conflicts of Interest: All authors are employees of Meiji Co., Ltd. The company funded this research. All authors are the inventors of pending patent (Japanese Patent Application No. 2023-182470).

Comment: The supplement is a bacterial probiotic. The authors are employed by its maker and hold a patent for it, which they fully disclose. Just as a reminder, industry-funded studies tend to come out with results favoring the sponsor’s interest, as is certainly the case here.

I need to say something about the journal, Nutrients, since many of the studies I post on industry-funded Mondays appear in that journal. It charges authors €2900 (about $3300) to publish their articles. It’s an open-access journal, so all authors have to pay to publish their articles. More rigorous journals do not usually require page charges from authors unless they want open access. Nutrients gives me the impression of pay to play.

Tags: Conflicts-of-interest, Supplements

Jan 23 2024

Kratom: a primer on its politics

I see stores selling Kratom all over my downtown Manhattan neighborhood and am curious about it (no, I have not tried it, nor do I intend to).

I took a look at the websitesof the American Kratom Association (AKA) and the FDA’s Kratom page.

The AKA describes itself as “a consumer-based, nonprofit organization, focuses on setting the record straight about kratom and gives a voice to those who are suffering by protecting their rights to possess and consume safe and natural kratom.” It says:

Natural kratom comes from the mitragyna speciosa, a tropical evergreen tree in the coffee family native to Southeast Asia…Naturally occurring Kratom is a safe herbal supplement that behaves as a partial mu-opioid receptor agonist and is used for pain management, energy, even depression and anxiety that are common among Americans. Kratom contains no opiates, but it does bind to the same receptor sites in the brain. Chocolate, coffee, exercise and even human breast milk hit these receptor sites in a similar fashion.

Thus, according to the AKA, Kratom is something like chocolate or breast milk.

The FDA, in fact, defines Kratom in much the same way:

Kratom is a tropical tree (Mitragyna speciosa) that is native to Southeast Asia…Kratom is often used to self-treat conditions such as pain, coughing, diarrhea, anxiety and depression, opioid use disorder, and opioid withdrawal. An estimated 1.7 million Americans aged 12 and older used kratom in 2021, according to the Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health.

So far so good.

But the AKA is calling on the FDA to regulate Kratom. This may sound highly responsible, but the AKA is doing this because the FDA refuses to have anything to do with this product and warns against its use.

The FDA says:

Kratom is not an approved drug: “There are no drug products containing kratom or its two main chemical components that are legally on the market in the U.S.
Kratom is not an approved dietary supplement: “FDA has concluded from available information, including scientific data, that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.’
Kratom is not an approved food additive: “FDA has determined that kratom, when added to food, is an unsafe food additive.”
Therefore, kratom is not lawfully marketed in the U.S. as a drug product, a dietary supplement, or a food additive in conventional food.

The FDA’s Q and A:

What can happen if a person uses kratom? FDA has warned consumers not to use kratom because of the risk of serious adverse events, including liver toxicity, seizures, and substance use disorder (SUD). In rare cases, deaths have been associated with kratom use…However, in these cases, kratom was usually used in combination with other drugs, and the contribution of kratom in the deaths is unclear.
How is FDA protecting the public from the risks of kratom? FDA has also taken steps to limit the availability of unlawful kratom products in the U.S. We will continue to work with our federal partners to warn the public about risks associated with use of kratom.

The AKA says its mission is to

Support Consumers. The FDA does everything it can do to interfere with the right of consumers to make informed choices about products they use for their health and well being, and their war on kratom includes distributing disinformation on kratom that materially misleads consumers and policy makers. Our goal is to change that.
Educate. Kratom is a natural plant that helps consumers improve their health and well being for centuries. Our goal is to educate all Americans with the truth about kratom — from potential consumers to regulators and everyone in between.
Speaking the Truth on Kratom. We represent millions of Americans that each have a story to tell. The FDA wants to drown out the individual voices, but we will raise those voices and together we will be heard across America.
Global Awareness. Anti-kratom detractors are trying to expand kratom bans across the world. We hope to demonstrate responsible use and the health benefits of kratom will convince other countries to responsibly regulate kratom, not ban it.
Protect Natural Resources. Kratom is a precious natural resource that is an important part of our global ecosystem. We support and advocate for sustainable harvesting techniques and reforestation protecting existing kratom forests to protect the climate and the invaluable carbon exchange kratom trees contribute to the environment.

Oh dear. While this disagreement continues, Kratom is readily available in shops that sell CBD and other cannabis derivatives.

What’s especially interesting about this difference of opinion is that the FDA usually keeps hands off —says not one word about—products sold as dietary supplements. It stays quiet about them as a result of court decisions following passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), which essentially deregulated herbal supplement products.

But the FDA has plenty to say about Kratom. That the agency argues that Kratom is not a drug, supplement, or food additive, means that it views Kratom as demonstrably harmful.

In situations like this, I tend to invoke the precautionary principle: see proof of safety before using it. I prefer to head off trouble whenever possible.

But this situation raises an interesting question. If the FDA thinks Kratom is all that bad, why isn’t it acting to take it off the market? Or stating that it wishes it could but DSHEA won’t let it. When the FDA tried to ban potentially harmful supplements, the makers of those supplements took the FDA to court. The courts generally ruled in favor of the supplement makers. Go figure.

Caveat emptor.

Tags: Supplements

Nov 27 2023

Industry-funded study of the week: a bacterial probiotic supplement and indigestion

This one started out with a notice in NutraIngredients Europe, a newsletter I subscribe to:

Probiotic BG01-4 relieves constipation and discomfort in GI disorders: Probiotic BG01-4 improves specific symptoms of constipation and related GI dysfunction in people with self-reported functional gastrointestinal disorders (FGID), which affects a significant percentage of the global population, a new study concludes…. Read more

That title triggered my usual question, “Who paid for this?”

I went right to the study:

The study: Bacillus Subtilis (BG01-4 ^TM ) Improves Self-Reported Symptoms for Constipation, Indigestion, and Dyspepsia: A Phase 1/2A Randomized Controlled Trial,by Craig Patch, Alan J. Pearce, Mek Cheng, Ray Boyapati, and Thomas Brenna. Nutrients2023, 15(21), 4490; https://doi.org/10.3390/nu15214490.
Background: Functional gastrointestinal disorders (FGIDs) are common, difficult-to-manage conditions. Probiotics are emerging as a dietary component that influence gastrointestinal (GI) health. We conducted a double-blinded randomised controlled trial of a proprietary strain of deactivated Bacillus subtilis (BG01-4™) high in branched-chain fatty acids (BCFA) to treat self-reported FGID.
Methods: Participants (n = 67) completed a four-week intervention of BG01-4™ (n = 34) or placebo (n = 33). The Gastrointestinal Symptom Rating Scale (GSRS) served as the outcome measure, collected prior to, at two weeks, and at four weeks after completion of the intervention.
Results: At four weeks, one of three primary outcomes, constipation in the experimental group, was improved by 33% compared to placebo (15%); both other primary outcomes, Total GSRS and diarrhoea, were significantly improved in both the experimental and placebo groups (32%/26% and 20%/22%, respectively). The pre-planned secondary outcome, indigestion, was improved at four weeks (32%) but compared to the placebo (21%) was not significant (p = 0.079). Exploratory analysis, however, revealed that clusters for constipation (18% improvement, p < 0.001), indigestion (11% improvement, p = 0.04), and dyspepsia (10% improvement, p = 0.04) were significantly improved in the intervention group compared to the placebo.
Conclusions: These initial findings suggest that in people with self-reported FGID, BG01-4™ improves specific symptoms of constipation and related GI dysfunction. Longer-term confirmatory studies for this intervention are warranted.
Conflicts of interest: C.P., M.C. and J.T.B. are directors of Adepa Lifesciences. The other authors declare that they have no conflicts of interest regarding the publication of this paper.

Comment: Three of the authors are involved with the maker of this supplement, Adepa Lifesciences, which makes this look like a marketing study. It is published in the journal, Nutrients, an open-access journal. Sharp eyed readers of this blog might notice that a large proportion of my industry-funded studies of the week appear in this journal. It has an interesting policy. It is fully open access and charges authors a fee accordingly. That fee amounted to $3200 on October 30).

Open Access and Article Processing Charge (APC)

All articles published in Nutrients (ISSN 2072-6643) are published in full open access. An article processing charge (APC) of CHF 2900 (Swiss Francs) applies to papers accepted after peer review. This article processing charge is to cover the costs of peer review, copyediting, typesetting, long-term archiving, and journal management. In addition to Swiss francs (CHF), we also accept payment in euros (EUR), US dollars (USD), British pound sterling (GBP), Japanese yen (JPY) or Canadian dollars (CAD).

Many science journals charge fees for open access, but usually offer authors a choice. For the record, I have never paid to have an article published.

Tags: Conflicts-of-interest, Probiotics, Supplements

Oct 2 2023

Industry-funded study of the week: Cannabis supplement

The study: A Randomized, Double-Blind, Placebo-Controlled Decentralized Trial to Assess Sleep, Health Outcomes, and Overall Well-Being in Healthy Adults Reporting Disturbed Sleep, Taking a Melatonin-Free Supplement. Nutrients. 2023 Aug 30;15(17):3788. doi: 10.3390/nu15173788.

Method: The study compared the effects on sleep of two THC-plus-botanical supplements against a placebo. The two supplements differed in proportions of THC and botanicals.

Results: The supplement with the lower amount of THC (0.35 mg) and higher amount of hops and valerian oils (75 mcg) yielded better sleep outcome than the placebo. The supplement with a higher amount of THC had no effect versus placebo.

Conclusion: “A botanical blend containing a low concentration of THC improved sleep disturbance, anxiety, stress, and well-being in healthy individuals that reported better sleep as a primary health concern.”

Funding: This research was funded by MDbio—The Doctors Brand™.

Acknowledgments: “The authors would like to express our deepest gratitude to the participant volunteers in this study without whom this study would not have been possible. We acknowledge and appreciate the hard work of the Radicle Science study operations team and MDbio—The Doctors Brand™ for the product formulas studied.”

Conflicts of Interest: “[Four of the eight authors] are employed by Radicle Science, the company who conducted the study. 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.”

Comment: Radicle Science is a contract research company in the business of doing clinical trials with supplements to provide data on which they can make structure/function claims, the special health claims allowed for supplements that require minimal scientific substantiation. MDbio, of course, makes the supplement used in this trial (you will be relieved to know that all their ingredients are non-GMO).

What interested me about this one is the THC (tetrahydrocannabinol) ingredient. It’s hard to know whether it made any difference. The supplement with higher THC levels but lower levels of botanicals had no effect. The composition of the placebo is not disclosed in the paper, and the data are not p).ublicly available (you can request them from the corresponding author).

Cannabis is greatly understudied as a result of long-standing prohibitions. As more of it gets into the food supply (edibles!), it would be good to get real information about its effects. My reading of this study suggests either that less THC is better for sleep. The less the better? That, we do not yet know.

Tags: Cannabis, Supplements

Sep 13 2023

Fruit-industry funded study of the day: III. Mango leaf extract

The study: Martinez-Canton M, Galvan-Alvarez V, Garcia-Gonzalez E, Gallego-Selles A, Gelabert-Rebato M, Garcia-Perez G, Santana A, Lopez-Rios L, Vega-Morales T, Martin-Rincon M, et al. A Mango Leaf Extract (Zynamite^®) Combined with Quercetin Has Exercise-Mimetic Properties in Human Skeletal Muscle. Nutrients. 2023; 15(13):2848. https://doi.org/10.3390/nu15132848

Hypothesis: Zynamite PX^®, a mango leaf extract combined with quercetin, enhances exercise performance by unknown molecular mechanisms.

Conclusion: Zynamite PX^® elicits muscle signaling changes in resting skeletal muscle resembling those described for exercise training and partly abrogates the stress kinases responses to exercise as observed in trained muscles.

Funding: This investigation was co-financed in part by Nektium Pharma S.L., Ministerio de Economía y Competitividad…Consejo Superior de Deportes de España (EXP_75097), FEDER and Cabildo de Gran Canaria…and FDCAN (Fondo de Desarrollo de Canarias).

Conflicts of Interest: The present investigation was partially financed by Nektium Pharma S.L, who provided the polyphenolic compounds and participated in the experimental design, although they were fully excluded from participation in experimental data collection, data analysis and interpretation of results. The remaining funding agencies had no role in study design, data collection, management, data analysis, interpretation of data, writing of the report, and the decision to submit the report for publication.

Comment: This is a classic example of an industry-funded supplement study with favorable interpreted favorably. The manufacturer paid for the study as part of a private-public partnership to aid businesses in the Canary Islands.

Tags: Fruit, Sponsored-research, Supplements

Aug 4 2023

Weekend reading: FDA’s curricula for middle and high school teachers

I started out my careeer as an instructor in a university biology department teaching cell and molecular biology. I got handed a nutrition course to teach and quickly discovered it was the best way to engage students in learning biology. I’ve never looked back.

Now the FDA has made the same discovery:

What captures the interest of students? FOOD! Yes, food can be used to engage students in inquiry-based science — really!

The Science and Our Food Supply Teacher Guides are challenging hands-on, minds-on activities that empower students to make informed choices about food safety, nutrition, biotechnology, and dietary supplements. They are crafted in a teacher-friendly modular format that easily fit into science, health, and other classes.

I. Food Safety: Science and Our Food Supply: Investigating Food Safety from Farm to Table (2014)

Resources

II. Nutrition: Science and Our Food Supply: Using the Nutrition Facts Label to Make Healthy Food Choices (2022)

III. Biotechnology: Science and Our Food Supply: Exploring Food Agriculture and Biotechnology (2020)

IV. Dietary Supplements: Science and Our Food Supply: Examining Dietary Supplements (2021)

Dietary Supplements High School Guide

COMMENT

I think these are pretty good and could make teaching these topics easy for teachers and fun for students. They are written intelligently and do not talk down. All of them provide useful sections on how to decide whether information sources are reliable. For that alone!

The curricula provide plenty to work with, even though they are decidedly non-controversail. You would never know from reading the one on biotechnology, for example, that the topic caused much in the way of debate.

Tags: FDA, Food-safety, GMOs, Labels, Supplements

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