Currently browsing posts about: Supplements

The New York Times’ obituary for the late Utah Senator Orrin Hatch, “Orrin Hatch, Seven-Term Senator and a Republican Force, Dies at 88,” filled an entire page of the newspaper.  That’s how important he was.

I was surprised that the obituary said not one word about Senator’s Hatch’s responsibility for the Dietary Supplement Health and Education Act of 1994 (DSHEA, pronounced d’shay).  The purpose of this act was to boost the supplement industry, which is well represented in Utah, by taking it out from under the regulatory authority of the FDA.

As a reminder, DSHEA:

• Assumed that dietary supplements were safe.
• Essentially deregulated them by weakening the FDA’s regulatory power.
• Permitted structure/function health claims on supplements, (e.g., supports a healthy immune system), regardless of level of scientific substantiation.
• Labeled supplements with Supplement Facts rather than Nutrition Facts.
• Forced the FDA to take manufacturers to court if agency regulators had concerns about safety, misleading claims, or inconsistent contents.
• Caused the FDA to lose court cases on First Amendment grounds.

The results:

• The supplement industry expanded rapidly, achieving DSHEA’s purpose.
• You cannot be sure that what you are buying is actually waht the label says you are buying.
• You cannot be sure that claimed benefits have any science behind them.
• Food manufacturers demanded the right to make struture/function claims.
• Use of the First Amendment to protect commercial (rather than personal, political, or religious) speech has gotten stronger.

We have Orrin Hatch to thank for turning the supplement industry into one based on faith, not science.

Why would he do this?

The obituary suggests one possibility:

During the opioid crisis in 2015, he introduced a bill to narrow the authority of government regulators to halt the marketing of drugs by predatory pharmaceutical companies. It later emerged that he had received $2.3 million in donations from the drug industry over 25 years.

For a more direct explanation, check out this article about Senator Hatch from the New York Times in 2011, “Support Is Mutual for Senator and Utah Industry.“

“Senator Hatch — he’s our natural ally,” said Marc S. Ullman, a lawyer for several supplement companies. Mr. Hatch, who credits a daily regimen of nutritional supplements for his vigor at 77, has spent his career in Washington helping the $25-billion-a-year industry thrive….Mr. Hatch has been rewarded with hundreds of thousands of dollars in campaign contributions, political loyalty and corporate sponsorship of his favorite causes back home.  His family and friends have benefited, too, from links to the supplement industry.

Hatch’s efforts to deregulate supplements did no good for public health or trust in science.  As the obituary said,

But there were no political repercussions. The senator was re-elected in 1982, 1988, 1994, 2000, 2006 and 2012, averaging nearly 65 percent of the vote.

Requiescat in pace.

Yesterday I reported about the COSMOS clinical trial demonstrating reductions in mortality among people taking cocoa flavanol supplements.

That trial had another arm: multivitamin supplements.

The study: Multivitamins in the Prevention of Cancer and Cardiovascular Disease: The COSMOS Randomized Clinical Trial.  Sesso HD et al.  The American Journal of Clinical Nutrition, nqac056, https://doi.org/10.1093/ajcn/nqac056

Conclusion: The supplements did not reduce cardiovascular disease, cancer, or all-cause mortality in older men and women.

Funding: The COcoa Supplement and Multivitamin Outcomes Study (COSMOS) is supported by an investigator-initiated grant from Mars Edge, a segment of Mars dedicated to nutrition research and products, which included infrastructure support and the donation of study pills and packaging. Pfizer Consumer Healthcare (now part of GSK Consumer Healthcare) provided support through the partial provision of study pills and packaging.

Conflicts of interest: Drs. Sesso and Manson reported receiving investigatorinitiated grants from Mars Edge, a segment of Mars Incorporated dedicated to nutrition research and products, for infrastructure support and donation of COSMOS study pills and packaging,
Pfizer Consumer Healthcare (now part of GSK Consumer Healthcare) for donation of COSMOS study pills and packaging during the conduct of the study. Dr. Sesso additionally reported receiving investigator-initiated grants from Pure Encapsulations and Pfizer Inc. and honoraria
and/or travel for lectures from the Council for Responsible Nutrition, BASF, NIH, and American Society of Nutrition during the conduct of the study. No other authors reported any conflicts of interest.

Comment: Pfizer, of course, makes Centrum multivitamin supplements aimed at older adults.

I was surprised by this part of the trial because previous studies have also shown no consistently beneficial effect of supplementation of individual vitamins or multivitamins on disease risk.  Pfizer must have hoped to find benefits for Centrum.  This is a rare industry-supported study that showed no benefits and is, therefore, worth attention.

Thanks to Lynn Ripley for this gem.

Who knew that herbal dietary supplements are now marketed for cows, with claims that they improve milk quality and yield and reduce methane emissions at the same time?  Not me, for sure.

The producer of this supplement says feeding a dairy cow one gram a day will produce these benefits. That’s not much for a 1500-2000 pound dairy cow, even feeding the gram a day for at least four weeks (which is what the manufacturer says you have to do).

This, to say the least, is hard to believe.

As evidence, the manufacturer, Agolin Ruminant, cites three studies of its supplement.   Want to take a guess as to who funded all three of them?  Bingo!  Agolin Ruminant.

My first question: what is in Agolin Ruminant that is so powerful that only one gram a day will produce measurable benefits?

This question is not easy to answer.

The manufacturer’s statement of product information says only:

AGOLIN RUMINANT L is a carefully balanced combination of essential oil compounds in their natural / nature-identical form. All active substances are of high purity and are accepted for use under current European animal feed and human food legislation.

In the meta-analysis summarized below, the authors say:

The main active compounds of this product are food grade and chemically-defined plant extracts including coriander (Coriandrum sativum) seed oil (up to 10%), eugenol (up to 7%), geranyl acetate (up to 7%) and geraniol (up to 6%) along with some preservatives such as fumaric acid.

Those account for 30% of what’s in the product.  The other 70%?  A mystery.

This supplement is a feed additive.  Animal feed products do not require the level of ingredient disclosure required for dietary supplements.  The manufacturer says all ingredients are either FDA-approved or Generally Recognized as Safe (GRAS).  All are plant extracts (available from cloves or geraniums, for example).   Great.  I’d like to know what they are.

The manufacturer points to an endorsement from the Carbon Trust for the value of this product for reducing methane emissions.

This opinion is based on academic references, published scientific papers and field reports and joins the conclusions of the independent meta analyses from A. Belanche et al.

Oh dear.  The Carbon Trust did not do its homework.  The article by Belanche et al, is anything but independent.

Here are the key studies attesting to the purported benefits of this supplement for cows, starting with Belanche et al.

I.  A Meta-analysis Describing the Effects of the Essential oils Blend Agolin Ruminant on Performance, Rumen Fermentation and Methane Emissions in Dairy Cows. Alejandro Belanche, Charles J. Newbold, Diego P. Morgavi, Alex Bach, Beatrice Zweifel and David R. Yáñez-Ruiz.  Animals 2020, 10, 620; doi:10.3390/ani10040620

Conclusion: This meta-analysis combining 23 experimental and farm studies across 10 different countries indicated that supplementation of lactating dairy cows with the essential oils blend Agolin Ruminant® (at 1g/d per cow) exerted positive effects on milk production whereas it decreased enteric methane emissions in comparison to un-supplemented cows. These effects mostly appeared after an adaptation period of approximately 4 weeks of treatment and consisted in an increase in fat and protein corrected milk suggesting an improved feed utilization.

Funding: This research received no external funding.

Acknowledgments: This study was supported by Agolin SA (Bière, Switzerland).

Conflicts of Interest: Author B.Z. was employed by the company Agolin SA but had no role in the design, execution, interpretation, or writing of the meta-analysis. The remaining 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:  Really?  Even though the authors cite support by Agolin SA?

II.  The Impact of Essential Oil Feed Supplementation on Enteric Gas Emissions and Production Parameters from Dairy Cattle Angelica V. Carrazco, Carlyn B. Peterson, Yongjing Zhao, Yuee Pan , John J. McGlone, Edward J. DePeters and Frank M. Mitloehner.  Sustainability 2020, 12, 10347; doi:10.3390/su122410347

Conclusion: Cows supplemented with Agolin versus the control had less methane intensity (g/period/kg
energy-corrected milk (ECM); p = 0.025).

Funding: This study was funded by Agolin (Agolin SA, Bière, Switzerland) and by Feedworks USA Ltd. (Ohio, USA).

Conflicts of Interest: The sponsor played no role in the execution and interpretation of the data and preparation of the present manuscript. The authors declare no conflict of interest.

III.  Evaluation of Agolin®, an Essential Oil Blend, as a Feed Additive for High Producing Cows.  Peter Williams1, John Clark, Kelly Bean  Open Journal of Animal Sciences, 11, 231-237. https://doi.org/10.4236/ojas.2021.112018

Conclusion: The trial showed that Agolin assisted in improving production parameters of economic importance to dairy producers.

Conflict of Interest: Mr. John Clark and Mr. Peter Williams market Agolin in the United States of America. Both were involved in the design but not the analysis of data or interpretation of results.

Comment

These are industry-funded supplement studies designed to sell a supplement of dubious benefit (my interpretation) to dairy producers to convince the public that they are doing all they can to reduce methane emissions.

The supplement doesn’t cost much per dose, but there are lots of dairy cows that have to be given the supplement for at least four weeks.

Without even getting into the details of the measurement difficulties or the overall science, two things are particularly troubling:

• The lack of transparency about ingredients
• The lack of a convincing mechanism of action

Call me skeptical.  I don’t see this supplement as a solution to the methane emission problem caused by ruminants.

A reader, Philly Nassau, sent me the ingredient list of several “immune-boosting” supplements, in quotes because I am a supplement skeptic in general, and of immune supplements in particular (I favor eating healthfully and staying active).

Immune supplements claim to be “Nootropics and Brain Supplement for Memory, Brain Support, Clarity, Focus, Mood Boost, Anti Anxiety & Stress Relief.”  Nootropics?  These are defined as drugs or supplements capable of enhancing memory, concentration, or other cognitive functions and of preventing cognitive decline.  How I wish.

But first, the science.

• Gut-microbiota-targeted diets modulate human immune status.  “The data highlight how coupling dietary interventions to deep and longitudinal immune and microbiome profiling can provide individualized and population-wide insight. Fermented foods may be valuable in countering the decreased microbiome diversity and increased inflammation pervasive in industrialized society.”
• The Stanford press release on this paper. A fermented-food diet increases microbiome diversity and lowers inflammation, Stanford study finds.  Stanford researchers discover that a 10-week diet high in fermented foods boosts microbiome diversity and improves immune responses.
• The New York Times account: How Fermented Foods May Alter Your Microbiome and Improve Your Health.  Foods like yogurt, kimchi, sauerkraut and kombucha increased the diversity of gut microbes and led to lower levels of inflammation.

Beyond eating healthfully and including fermented foods in the diet, here’s what’s being said about diet and immunity.

• Immune health is a marketing opportunity: Given current events, it’s likely that there has been no greater focus on immune health amongst consumers than right now. The market opportunity in this space is staggering, with immunity supplements showing an explosive 72.3% growth in 2020.
• Euromonitor Immunity Report: How to appeal to the holistic health shopper:  As consumers search for holistic and natural ways to improve their immunity, Euromonitor has published a new white paper examining how brands can appeal in a competitive and confusing market…. Read more
• Is immunity really the top functional choice for consumers in a pandemic era?  It sounds pretty logical – the pandemic has prompted increased interest in immunity across F&B. But is it really top dog in the world of functional beverages – or are there other claims consumers are more interested in?… Read more
• Parents are looking for immune-boosting options for school kids. Grocery retailers and packaged food and beverage brands should brace for another significant shift in consumer shopping habits this month as many families with students returning to in-person school after a year or more of distance or hybrid learning look for more on-the-go, budget-conscious and immune-boosting breakfast and lunch solutions.
• Immunity in a glass: Orange juice bioactives may bolster immunity and reduce inflammation:  The micronutrients and other bioactives contained in a glass of orange juice is sufficient enough to shore up the immune response and tackle oxidative stress and inflammation, a review concludes…. Read more  
• Beyond immunity: What ‘superpowers’ do today’s consumers want from their beverages?  The pandemic has propelled immunity to the top of the functional beverage agenda. But that doesn’t mean interest in other functional beverages has disappeared. We ask the experts what trends are bubbling away beneath the pandemic headlines – and will become all the more important to everyday heros in the coming years…. Read more  
• Shiitake happens: Mushrooms to play key role in immunity nutrition and health, concludes report:  Concerns over immune health and the pandemic has thrust the humble mushroom into the spotlight as experts hail the fungi’s ability to interact with gut microbes that influence healthy immune and inflammatory responses…. Read more  

Lots of people take supplements in the hope that they will help with body weight.  This is a big market.  Drug companies want in on it.  Most drugs don’t work, or have deal-breaking side effects.  In June,  The FDA approved Novo Nordisk’s Semaglutide for obesity management.

I subscribe to the Obesity and Energetics newsletter, which sends out weekly lists of research, articles, and commentary on those topics—a great way to stay up on current literature.

On July 2, it featured:

• From the Obesity Society: “Health care providers should be aware of the lack of evidence and deficiencies in regulatory oversight of dietary supplements marketed for weight loss.”  

This referred to: Perspective: Dietary supplements and alternative therapies for obesity: A Perspective from The Obesity Society’s Clinical Committee.  Srividya Kidambi, John A. Batsis, William T. Donahoo, Ania M. Jastreboff, Scott Kahan, Katherine H. Saunders, Steven B. Heymsfield.  Obesity 23 June 2021.

Our recommendation to clinicians is to consider the lack of evidence for non-FDA-approved dietary supplements and therapies and guide their patients toward tested weight management approaches…we call on regulatory authorities to critically examine the dietary supplement industry, including their role in promoting misleading claims and marketing products that have the potential to harm patients.

I am with the Obesity Society on this one, but what caught my interest was that several of the authors report financial tied to drug companies with interests in pharmacologic approaches to obesity treatment.

Conflicts of interest: SK serves as Medical Editor for TOPS Magazine (TOPS Inc. nonprofit weight loss club) and as Director for the TOPS Center for Metabolic Research at the Medical College of Wisconsin supported by TOPS Inc. JAB’s research reported in this publication was supported in part by the National Institute on Aging of the National Institutes of Health (NIH) under Award Number K23AG051681. JAB reports equity in SynchroHealth LLC. AMJ’s research is supported by the NIH/NIDDK, the American Diabetes Association, Novo Nordisk, and Eli Lilly; she serves as a consultant for Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. SKa has served as a consultant for Novo Nordisk, Vivus, Gelesis, and Pfizer. KHS reports an ownership interest in Intellihealth. SBH reports his position on the Medical Advisory Board of Medifast Corp.

The newsletter also featured the article referred to in the Perspective.

• Systematic Review: Dietary Supplements and Alternative Therapies for Weight Loss.

When I clicked on this link, it took me to the page where I could download the pdf.  I got the paper at this site.   But before I could read it, I had to see an ad for Novo Nordisk’s drug, Semaglutide.  Then I scrolled down to get the study:  A Systematic Review of Dietary Supplements and Alternative Therapies for Weight Loss.  John A. Batsis, John W. Apolzan, Pamela J. Bagley, Heather B. Blunt, Vidita Divan, Sonia Gill, Angela Golden, Shalini Gundumraj, Steven B. Heymsfield, Scott Kahan, Katherine Kopatsis … Obesity (2021) 29, 1102-1113

Study conclusion: “There is weak evidence for the efficacy of dietary supplements and alternative therapies.”

Authors’ disclosure: JAB reports equity in SynchroHealth LLC. AG reports consulting with Novo Nordisk and Unjury. SH reports personal fees from Medifast. SKa reports personal fees from Novo Nordisk, Pfizer, Vivus, and Gelesis. DR reports consulting and speaking fees for Novo Nordisk and Astra Zeneca. KHS has a relationship with Intellihealth Inc. SK is the medical director for TOPS Center for Metabolic Health at the Medical College of Wisconsin, which is supported by TOPS Inc. SBH reports his position on the Medical Advisory Board of Medifast Corp.

I much prefer dietary approaches to weight management and policy strategies to make healthy diets the easy choice.

I am almost never in favor of supplements.  The evidence that they do much beyond placebo effects is usually pretty weak.

The ad gives the side effects for Semiglutide; it has to.

My point: all of this seems to be about marketing Semiglutide.

I read about this one in NutraIngredients.com.

While previous animal studies have suggested a significant impact of the gut microbiota on the development and maturation of brain networks that underlie emotional behaviour, fewer studies have been conducted on humans. Intake of a galacto-oligosaccharides (GOS) prebiotic over 3 weeks has been shown to lower the secretion of the stress hormone cortisol and emotional processing in healthy adults, suggesting that GOS intake may be useful in modifying anxiety-related psychological mechanisms. However, reviews and meta-analyses on the efficacy of prebiotics for reducing anxiety symptomology are mixed, calling for further well controlled trials in human participants.

I am always curious to know who pays for this kind of research, so I looked up the study.

Anxiolytic effects of a galacto-oligosaccharides prebiotic in healthy females (18-25 years) with corresponding changes in gut bacterial composition.  Nicola Johnstone , Chiara Milesi , Olivia Burn, Bartholomeus van den Bogert, Arjen Nauta , Kathryn Hart , Paul Sowden, Philip W J Burnet, Kathrin Cohen Kadosh.   Sci Rep 2021 Apr 15;11(1):8302.

The study: “We examined multiple indices of mood and well-being in 64 healthy females in a 4-week double blind, placebo controlled galacto-oligosaccharides (GOS) prebiotic supplement intervention and obtained stool samples at baseline and follow-up for gut microbiota sequencing and analyses. We report effects of the GOS intervention on self-reported high trait anxiety, attentional bias, and bacterial abundance, suggesting that dietary supplementation with a GOS prebiotic may improve indices of pre-clinical anxiety.”

Conflict of interest statement: AN is an employee of FrieslandCampina, Amersfoort, The Netherlands. BvdB reports co-ownership of MyMicroZoo, Leiden, The Netherlands with no financial benefit from contributions to this manuscript. NJ, CM, OB, KH, PS, PWJB and KCK declared no financial or potential conflicts of interest.

Comment:  Probiotics are microorganisms that maintain a healthy microbiome.   They are typically found in fermented foods like yogurt.  Prebiotics are substances in food—or, in this case, supplements—that feed probiotic microbes.  This prebiotic supplement is GOS, a complicated chain of sugar molecules that is found in milk.

Why would an employee of FrieslandCampina want to do this study?  “Milk is the foundation of everything we do at FrieslandCampina.”

Why would a co-owner of MyMicroZoo be interested?  “The MyMicroZoo analysis shows the composition of your microbiota, and gives insight into how to improve your vitality.”

I’m all for eating yogurt (but watch out for the added sugars).  But GOS supplements?  Pardon my industry-induced skepticism.

Everybody wants to get into CBD edibles.  They have the potential to make lots of money for lots of people.

Here are a few recent items.

CBD ice cream:  Way back in 2019, Ben and Jerry’s, always on the cutting edge, promised to move right in.  I haven’t seen any yet, but can’t wait.

CBD pet food: Martha Stewart, also ever ahead of the curve, is doing a new line of products.

CBD alcohol: Product names or descriptors such as ‘CBD gin’ or ‘rum infused with CBD’ could prove problematic in the UK, says the Portman Group, as it sets out guidance on marketing CBD…. Read more

CBD supplements: Rugby warriors tackle cannabinoid concerns with CBD startup:  Two professional rugby players have created a startup selling third-party tested CBD supplements that give elite athletes and everyday consumers peace of mind over cannabinoid content.. Read

CBD edible hazards: Four children needed hospital treatment in England after eating sweets thought to have contained cannabis. A 12-year-old boy was discharged on May 1 and the other three were expected to be released from hospital in Surrey after being kept in overnight for monitoring and observation.  Continue Reading

CBD hazard regulation (or lack thereof): CBD experts recommend THC limit for finished products.  CBD industry experts have put together a detailed safety review of THC recommending clear policy recommendations to cut market confusion… Read

Regulations are sure to come, and the sooner the better—for reasons of public safety, but also to give startups some guidelines.

The Study:  Maaike J. Bruins and Ulla Létinois. Adequate Vitamin D Intake Cannot Be Achieved within Carbon Emission Limits Unless Food Is Fortified: A Simulation Study.  Nutrients 2021, 13(2), 592; https://doi.org/10.3390/nu13020592

Conclusion: The present study shows that adequate intakes for vitamin D cannot be achieved with the current diet alone within realistic calorie and carbon emission limits, and additional vitamin D sources are needed to overcome the shortfalls. Universal fortification along with small dietary shifts represents an approach to improve the vitamin D status of the general population, at a high acceptability without affecting the carbon footprint.

Conflicts of Interest: M.J.B. and U.L. are employed by DSM Nutritional Products, a manufacturer of nutritional ingredients.

Comment: Study after study shows that vitamin D supplements do not make healthy people healthier, but the idea persists and supplement companies take advantage of faith in these products.  Well, there isn’t much evidence for harm either, but sunshine on skin is a better source by far.

OK.  I know there’s a big controversy about this.

Here’s a study that shows benefits for patients with COVID; supplements were associated with keeping people out of intensive care.  One of its authors has financial ties to supplement companies, but the study has been criticized on other grounds as has a member of the British Parliament who thinks it provides evidence for supplementing everyone.

And here’s an independently funded study in JAMA shows that vitamin D to have no effect on patients hospitalized with Covid-19.

This one, comes with an editorial.

Given the lack of highly effective therapies against COVID-19, except perhaps for corticosteroids, it is important to remain open-minded to emerging results from rigorously conducted studies of vitamin D (despite smaller sample sizes and important limitations of some studies). However, taken together with existing randomized clinical trials of vitamin D administration in hospitalized patients with respiratory infection and critical illness, the results reported by Murai et al¹² do not support routine administration of vitamin D in hospitalized patients with moderate to severe COVID-19.

Fortunately, vitamin D supplements are unlikely to be harmful unless taken in very large doses.

Sunshine, anyone?