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Anil Yadav is head of quality assurance at Vedic Lifesciences Pvt. Ltd. (Mumbai, India), a contract research organization (CRO) serving the dietary supplement industry by performing clinical and toxicological work. Visit 

Like so much in the world, patient-reported outcomes (PROs) in clinical trials are now recorded digitally, offering numerous benefits.

Reporting patient outcomes in clinical trials: Why moving to electronic PROs makes sense

Central pathology labs are increasingly important resources in dietary supplement clinical trials, but even they need to be assessed especially in COVID times.

COVID and the central lab: A checklist for the dietary supplement industry

OmniActive Health Technologies (Bridgewater, NJ and Mumbai, India) has announced a partnership with the Council for Responsible Nutrition (CRN; Washington, D.C.) to educate and raise awareness about the role of lutein and zeaxanthin in supporting maternal and fetal health during pregnancy among obstetricians, gynecologists, and other maternal healthcare practitioners. This knowledge will be shared at The American College of Obstetrics and Gynecology’s (ACOG) Annual Clinical & Scientific Meeting. OmniActive is 

one of six companies CRN has partnered with

 to showcase the latest research and developments in prenatal nutrition through a specially designed “Prenatal Nutrition Center” at the conference. 

“It’s wonderful to have OmniActive as one of our featured partners during the ACOG annual event to help spread the word on the importance of prenatal nutrition,” said Andrea Wong, PhD, senior vice president, Scientific & Regulatory Affairs for CRN, in a press release. “CRN continues our efforts in supporting supplement manufacturers and ingredient suppliers in bringing clinically studied products to consumers to help meet their nutritional needs. Advancing awareness at the physician’s level is a huge part of this equation and this meeting is an effective way of reaching them.”

Citing market research from SkyQuest Technology, OmniActive explains in its press release that prenatal supplement sales were estimated to be at $740 million in 2023 and projected to rise to $1.4 billion by 2031. Similarly, a recent 

 found that about 60% of gynecologists think that 80-100% of their pregnant patients take dietary supplements. There is therefore a great deal of opportunity to grow and advance this category. Lutein and zeaxanthin are known for their support of eye health, but these benefits are relevant during pregnancy as well, says Deshanie Rai, PhD, FACN, vice president of Global Science, Regulatory and Advocacy at OmniActive Health Technologies.

“Current evidence supports the preferential accumulation of lutein and zeaxanthin in the human eye and neural tissues during pregnancy, especially during the third trimester. This suggests that lutein may play a functional and protective role in infant visual and cognitive development. As part of our Lutein for Every Age campaign, our goal is to help educate healthcare practitioners on this latest nutritional science research and the benefits of achieving adequate dietary lutein during pregnancy,” said Rai, in a press release. “OmniActive is proud to partner with the CRN Foundation’s Prenatal Nutrition Centre to promote awareness among healthcare practitioners on the nutritional relevance of lutein for both mom and baby.”

The educational initiative, “Lutein for Every Age,” focuses on raising awareness of early and consistent lutein and zeaxanthin intake to help support eye, cognitive, and general health throughout life, explains OmniActive. The AOCG meeting is taking place from May 17-19, 2024 in San Francisco, CA.

OmniActive Health Technologies has announced a partnership with the Council for Responsible Nutrition to educate and raise awareness about the role of lutein and zeaxanthin in supporting maternal and fetal health during pregnancy among obstetricians, gynecologists, and other maternal healthcare practitioners. 

Topic

OmniActive partners with CRN to raise awareness about macular carotenoids for prenatal health

On October 29, 2024, the Council for Responsible Nutrition (CRN) revealed the results from their 2024 Consumer Survey. According to the report data, three-quarters of Americans utilize dietary supplements and reflects the 75% usage rate that was witnessed in the previous year (1). Conducted by Ipsos, the CRN’s 2024 Consumer Survey highlighted the continuous presence nutritional supplements have in consumers choices in their health and wellness, as well as any changes in decisions with products (1).

“The stability in supplement use reflects the enduring trust that consumers place in our FDA-regulated industry,” Jeff Ventura, Senior Vice President of Communications at CRN mentioned (1). Ventura added that, “At the same time, we continue to see consumers exploring new specialty products and embrace personalized health solutions. This speaks to the evolving landscape of wellness, where supplements are becoming more integrated into individualized health practices.”

 disclosed how almost eight in 10 consumers “…prefer using supplements over over-the-counter or prescription medications whenever appropriate,” (1). Brand loyalty was also shown as 71% of the participants preferred repeatedly using specific brands consistently. The supplements showing increased usage were ashwagandha, magnesium, and prebiotics. This year, ashwagandha rose to 8% use in supplement users which is a significant increase from 2% that was reported in 2020. Utilization of magnesium was 23%, higher than the previous year where data listed usage at 19% (1). The report also mentioned that the use of the sleeping aid, melatonin, rose from 10% which was reported back in 2020, and is now 16%. The press release explained how the results regarding melatonin usage, mean that the supplement is one of the top specialty supplements researched in the Consumer Survey (1).

Information from the survey highlighted that consumers are consistently choosing to turn to nutritional supplements because of health and wellness which was the main reason reported in 2023 as well. In regard to supplement use, young women showed higher usage than men (1). The primary reason for the higher female utilization was displayed in supplement choices that would help benefit hair, skin, and nail health. Aside from those types of supplements, energy and immune health were additionally significant reasons for consumer use, according to the data (1).

According to the press release (1), “…supplement users generally are more likely to report participating in healthy behaviors compared to non-users. Regular users are more likely to report visiting their doctor regularly and trying to eat a balanced diet. While 41% of non-users cite lack of perceived need as the main reason for not taking supplements, a notable portion, 27%, also mentions cost as a barrier. Despite stable overall trust in supplements, non-users report lower levels of confidence in supplement effectiveness and safety compared to prior years, underscoring ongoing challenges in expanding the user base.” CRN performed the report online and in English. It took place from August 7-12, 2024 (1). During that time period, the survey received participation from 3,194 adults. From that pool of responses, there were 2,332 supplement users and 862 non-users. The press release mentioned that the demographics from the 2024 Consumer Survey included, “oversamples of Black, Hispanic, and Asian/Pacific Islander respondents to ensure diverse perspectives,” (1). The survey also measured credibility intervals. For all participants, the credibility interval was ±2.1 percentage points, supplement users was ±2.5 percentage points, and ±4.1 percentage points was reported for non-users (1).

To learn more about the survey, please visit: 

CRN survey shows consistent supplement usage with increase of specialty product use over time 

https://crnusa.org/newsroom/crn-survey-shows-consistent-supplement-usage-increase-specialty-product-use-over-time

The Council for Responsible Nutrition (CRN) revealed the findings from their 2024 Consumer Survey.

Council for Responsible Nutrition discloses 2024 Consumer Survey results showcasing increasing of specialty product usage

 compared different probiotic formulations marketed for the reduction of colic symptoms. The study compared AB-Biotics and Kaneka Probiotics’ probiotic formulation of 

The randomized, multicenter, parallel, single-blind trial was conducted in 112 colicky infants over 21 days. The primary study outcomes of the study were the percentage of responders, defined as a ≥ 50% reduction in crying and fussing time from baseline, as reported by parents in a structured diary, and daily crying and fussing time (minutes/day) on days 7, 14, and 21 after randomization. The results showed that the group taking the BP+PP saw a significantly higher responder rate compared to LR after seven days (61.1% vs. 37.5%) and 14 days (84.6% vs. 59.3%), as well as a significantly lower crying and fussing time after 7, 14, and 21 days.

Jordi Espadaler, director of innovation at AB-Biotics explained to 

 at SupplySide West 2024 that LR is a well-established strain, but that most of its research shows efficacy of breast-fed babies and that research on formula-fed babies taking this strain is scarce. The goal of AB-Biotics was therefore to create a product that showed efficacy regardless of the mode of feeding. Because of the lack of research on formula-fed babies for LR, the company has been unable to accurately compare the different products.

“So, we took a decision some years ago to run a head-to-head clinical study, which is quite standard in pharma where we use them to develop better treatment strategies, but in the dietary supplement that is not common,” said Espadaler. Ultimately, the study’s results showed that BP+PP may be more effective than LR for colicky infants, and “proved that [BP+PP] was effective regardless of the mode of feeding, which was essentially the reason for developing that product from the beginning.”

“This study is the culmination of years of dedicated research and development by our team of experts,” said Sergi Audivert, executive director and co-founder of AB-BIOTICS, in a press release. “Our unprecedented trial comparing the established support for infant colic with our new probiotic solution, not only strengthens the position of our probiotic for colic as the most effective probiotic for colic, but supports our ultimate goal to increase the quality of research around probiotics for infants, ensuring we strive to further alleviate the severity of functional gastrointestinal disorders globally.”

Moreno-Villares, J.M.; Andrade-Platas, D.; Soria-Lopez, M.; Colome-Rivero, G.; et al. Comparative efficacy of probiotic mixture Bifidobacterium longum KABP042 plus Pediococcus pentosaceus KABP041 vs. Limosilactobacillus reuteri DSM17938 in the management of infant colic: a randomized clinical trial. 

The study compared AB-Biotics and Kaneka Probiotics’ probiotic formulation of Bifidobacterium longum KABP®-042 and Pediococcus pentosaceus KABP®-041 to Lactobacillus reuteri DSM17938 (LR) from Biogaia.

Recent study compares the effectiveness of two probiotic products on colicky infants

SupplySide West 2024 recently concluded in Las Vegas, NV, bringing the industry together under one roof to deliver a wide range of ingredient solutions to manufacturers of dietary supplements and foods. As with previous years, this most recent show brought new innovations and insights on trending categories. One notable trend from the show is the opportunity that the usage and awareness of GLP-1 agonist drugs presents for industry. This opportunity presents itself in two ways: 1) Dietary supplements that promotes the GLP-1 hormone as a mechanism of action, or 2) Ingredients that complement GLP-1 agonist drugs by maintaining muscle health and nutrition during the weight loss the drug promotes.

The former is tied into metabolic health, which includes weight management, blood sugar management, and inflammation. For example, Ingredients by Nature (Montclair, CA) has announced that it will be offering a probiotic strain called 

 AKK11, which is referred to as the “longevity probiotic.” The ingredient plays into the healthy aging trend and has been shown in research to support healthy inflammation and metabolic health. Animal research has demonstrated that the probiotic can promote the secretion of GLP-1 as well as brown adipose tissue thermogenesis. (1) More research is necessary to further explore this mechanism in humans, but the probiotic also complements the company’s lemon-based flavonoid ingredient Eriomin which was found in a clinical trial to decrease blood sugar and increased GLP-1.(2)

“It's by far the hottest thing I've ever seen in my 20 years, and it's not a fad,” says Robert Brewster, president of Ingredient by Nature. “GLP-1 is not going away.”

Brewster explains that the benefits of promoting GLP-1 goes beyond satiety to include brain health and overall metabolic health. “More and more is being understood biologically about what GLP-1 is doing, how it's working on the brain for satiety,” adds Doug Lynch, strategic sales for Ingredients by Nature. “It also affects the motility. So, ultimately when food passes through, it travels at a slower pace and that allows you to get filled up more quickly. It's also involved with insulin production.”

Of course, Brewster and Lynch emphasize the importance of responsibly marketing products such as these. Increasing GLP-1 is a mechanism for these products, but they are by no means equivalent the popular GLP-1 agonist drugs. Indeed, the viral concept that catapulted berberine to the mainstream as “nature’s Ozempic” is something brands like Ingredients by Nature want to distance themselves from.

That said, the recognition and association consumers have of GLP-1 is bound to encourage further research into this mechanism. A recently launched collagen peptide from Rousselot (Son, The Netherlands) called Nextida GC was shown in animal research to lower blood glucose response, slow down gastric emptying, increase plasma insulin, and increase GLP-1. In a small proof of concept study with humans, the ingredient was able to lower postprandial glucose response. (3) A newly introduced probiotic from IFF (New York), 

 advances the scientific literature on Akkermansia strains, with mechanisms that may positively impact inflammation, immunity, metabolic health, and even offer neuroprotective effects. (4) There is no research on GLP-1 impacts yet, but further research is bound to explore this mechanism in comparison to 

Another direction manufacturers can go is helping users of GLP-1 agonist drugs deal with symptoms. One common area of support is muscle health. Because of the rapid weight loss people taking GLP-1 agonist drugs can experience, they also lose muscle mass. Therefore, being able to maintain muscle mass during weight loss allows people to be more active and maintain that weight loss. An ingredient like Mobilee, a proprietary hyaluronic acid matrix ingredient from Bioiberica (Barcelona, Spain), has been shown via 

 models to have muscle health benefits with the potential to protect against muscle atrophy and damage related to sarcopenia, which is age-related muscle decline. (5)

Along similar lines, Beta-hydroxy beta-methylbutyrate (HMB) such as myHMB from TSI Group (Shanghai), has been shown in research to support muscle mass and strength in aging populations even without the addition of exercise. (6) In more active populations, Gelita’s (Eberbach, Germany) BobyBalance and TendoForte collagen peptides have been shown to increase the rate of muscle grown following resistance training. (7) While more research is necessary to determine the specific effects of these products on GLP-1 agonist users, the established muscle-health benefits of such ingredients may be a welcome complement to those taking the drugs.

Another factor to consider is overall nutrition. Patients taking the GLP-1 agonist drugs lose weight because they eat less, which has the potential to impact their overall nutrition. (8) For example, Michael VanderDrift, senior marketing communications manager at Balchem (Montvale, NJ) suggests that the chelated forms of minerals in the Albion Minerals portfolio can be a valuable addition to this population for maximizing mineral absorption in the face of the change in metabolism and transit times that GLP-1 agonist drugs bring.


Another factor to consider, says senior marketing and BD manager for Balchem, Jessica Arnaly, is skin health. She cites the “Ozempic skin effect” which is characterized by increased signs of aging and a hollowed out appearance in the face due to rapid weight loss and lack of hydration. Arnaly therefore says that OptiMSM is another suitable companion for GLP-1 agonist users. Research has shown that the ingredient supports skin elasticity and hydration to improve signs of aging. (9)

Supplements have long been used as a complement to pharmaceutical therapies, with statins and CoQ10 being one major example. Supplements may therefore have a great deal to offer GLP-1 agonist users. For those that are not interested in the drug, but are intrigued by the mechanism and the potential to manage weight and support metabolic health, dietary supplements that promote GLP-1 secretion are bound to increase as well as the body of scientific literature on the hormone grows. Brands should however be sure to responsibly market such products as to avoid being conflated with drugs.

Jian, H.; Liu, Y.; Wang, X.;Dong, X.; Zou, X. Akkermansia muciniphila as a Next-Generation Probiotic in Modulating Human Metabolic Homeostasis and Disease Progression: A Role Mediated by Gut–Liver–Brain Axes? 

Cesar TB et al. “Nutraceutical Eriocitrin (Eriomin) reduces hyperglycemia by increasing glucagon-like peptide 1 and downregulates systemic inflammation: A crossover-randomized clinical trial.” 

Grasset, E.; Briand, F.; Virgilio, N.; Schon, C.; Wilhelm, M.; Cudennec, B.; Ravallec, R.; Aboubacar, H.; et al. A Specific Collagen Hydrolysate Improves Postprandial Glucose Tolerance in Normoglycemic and Prediabetic Mice and in a First Proof of Concept Study in Healthy, Normoglycemic and Prediabetic Humans. 

Kumar R.; Hasselwander, O.; Kane, H.; Hibberd, A.A. Akkermansia beyond muciniphila - emergence of new species Akkermansia massiliensis sp. nov. 

Grebow, J. Bioiberica’s Mobilee hyaluronic acid matrix may support muscle health and possibly sarcopenia, new research shows. 

https://www.nutritionaloutlook.com/view/bioiberica-s-mobilee-hyaluronic-acid-matrix-may-support-muscle-health-and-possibly-sarcopenia-new-research-shows

Krawiec, S. Meta-analysis finds that HMB supplementation supports healthy muscle mass in older adults. 

https://www.nutritionaloutlook.com/view/meta-analysis-finds-that-hmb-supplementation-supports-healthy-muscle-mass-in-older-adults

Grebow, J. Gelita collagen peptides increase muscle mass in new study. 

https://www.nutritionaloutlook.com/view/gelita-collagen-peptides-increase-muscle-mass-in-new-study

Berman, R. Weight loss: New dietary guidelines for people taking Wegovy, Ozempic. 

https://www.medicalnewstoday.com/articles/new-dietary-guidelines-weight-loss-drugs#Risks-of-nutritional-imbalances-while-taking-weight-loss-drugs

Krawiec, S. MSM may improve signs of aging, says recent study. 

https://www.nutritionaloutlook.com/view/msm-may-improve-signs-aging-says-recent-study

GLP-1 was a major point of discussion on the SupplySide West show floor. We explore how dietary supplements fit into this game-changing mechanism for metabolic health and weight management.

The role of dietary supplements on GLP-1: SupplySide West 2024 Report

Akay Bioactives  announced the publication of a randomized placebo-controlled study

 investigating the effects of its Immufen ingredient on mild allergic rhinitis. Immufen is a complex of ashwagandha and curcumin standardized to withanolides and curcuminoids using the company’s FenuMat technology. According to Akay, FenuMat is a plant-based co-delivery system that ensures consistent release of soluble bioactives to optimized overall bioavailability.

In the 28-day study, 105 participants were randomized to receive either the ashwagandha and curcumin complex, a bioavailable curcumin, or placebo twice daily. Researchers measured allergic rhinitis symptoms and quality of life using Total Nasal Symptom Score (TNSS), Bergen Insomnia Scale (BIS), and the Profile of Mood States Short Form (POMS-SF) questionnaire at both baseline and study completion.

Results showed the complex significantly decreased symptoms associated with allergic rhinitis. Specifically, the complex reduced nasal congestion by 34.64%, runny rose by 33.01%, nasal itching by 29.77%, sneezing by 32.76%, and TNSS by 31.62%. Compared to the complex, the bioavailable curcumin did not significantly effect symptoms and TNSS, except sneezing.

"These results represent a significant breakthrough in natural, plant-based solutions for seasonal health,” said Krishnakumar IM, PhD, chief research officer of Akay Bioactives, in a press release. “Immufen stands out for its effectiveness and its positive impact on participants' overall well-being."

M.K.; Aryan, M.K.; Pranhakaran, P.; Mulaki, J.N.; S.D.S.; IM, K.; Panicker, S.P. Short-term influence of Immufen™ on mild allergic rhinitis: a randomized, double-blind, placebo-controlled study. 

The randomized placebo-controlled study investigating the effects of Akay Bioactives' Immufen ingredient on mild allergic rhinitis.

Branded ashwagandha and curcumin complex may offer allergy relief according to recent study

conference, October 9-11, in Salt Lake City, Utah, the Council for Responsible Nutrition (CRN) first held the WellComms forum—six presentations intended for marketing and communications professionals. In the first presentation, Brian Yam, VP of Regulatory Affairs and Quality Assurance at Blue Ocean Regulatory Inc. presented, “How To Last in the Amazon Game – How Brands Are Navigating Amazon’s Latest Compliance Requirements.” Yam covered the past, present, and potential future of Amazon requirements.

He first walked through the process of getting a brand on Amazon through a seller’s point of view in order to highlight the compliance and verification issues that naturally arise during this journey. Yam discussed the certification requirements from 2023, in which sellers needed, for example, to provide a certificate of analysis (COA) to Amazon. However, Amazon’s initial requirements enabled the retesting of a product until it produced a passing result, fabrications of a COA, or calculating the amount of an ingredient in a capsule, rather than actually testing for it. 

In April 2024, Amazon’s requirements were updated to include new information needed from sellers, such as requiring specific contaminants to be tested for, and for all the required product documentation to be funneled through designated laboratories to verify the results, instead of directly through Amazon. “This was a huge wake up call for the brands,” Yam stated. Brands realized ingredients hadn’t been tested for quantity and the validity of manufacturers’ GMP certification was questioned.

He then presented six best practices for navigating Amazon’s latest requirements for today and for the long term:

Use accredited GMP certified manufacturers

Set explicit testing specifications for the product

Conduct third party testing now so issues can be resolved before the inventory leaves the facility

Establish non-compliance protocols with the manufacturing and what the manufacturer will to do to make it right

As a bonus tip, he explained the overlap between products that are NSF certified and compliance with Amazon’s policies.

Next, Yam explained three potential future directions for Amazon compliance:

Mandating that the set of products sent to laboratories for testing come from the Amazon warehouse

Minimizing friction for seller and reduce backlogs

In his CRN Convergence '24 conference presentation, Brian Yam of Blue Ocean Regulatory Inc. discussed how brands can last in Amazon’s marketplace.

Anil Yadav

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