Joint cartilage protection: Stratum Nutrition's second trial of NEM eggshell membrane underway
13 Feb 2019 --- Stratum Nutrition has launched a progressive joint health clinical trial to evaluate its eggshell membrane joint health ingredient, NEM. The trial is being conducted in an exercising, healthy population and is an expanded follow up to Stratum’s 2018 healthy, post-menopausal women trial. With a second randomized controlled trial, the company hopes to substantiate future labeling and advertising claims.
“With this ongoing study, we intend to satisfy both US FDA’s and FTC’s strong preference for two randomized controlled trials (RCTs) to substantiate labeling and advertising claims. With the added benefit that both RCTs were conducted in exercising healthy populations, brand marketers will have access to meaningful claims that will resonate with end consumers,” comments Kevin J. Ruff Ph.D., Senior Director of Scientific & Regulatory Affairs for Stratum Nutrition.
The back-to-back trials are intended to evaluate whether NEM can reduce cartilage turnover or alleviate joint pain and stiffness. The previous 2018 study found that a once daily, 500 mg dose of NEM rapidly improved recovery from exercise-induced joint pain and stiffness, as well as significantly reduced discomfort immediately following exercise. A substantial chondroprotective effect was also demonstrated from NEM supplementation through a lasting decrease in the cartilage degradation biomarker, CTX-II.
The follow-up trial includes a larger population – 84 subjects vs. 60 in the previous trial – as well as a demographic of both men and women ages 40-75, while the prior trial studied post-menopausal women. As before, subjects were healthy and could not have had persistent knee or ankle pain while at rest in order to participate.
The patented trial design looks at changes in a cartilage degradation biomarker, CTX-II, in exercising healthy individuals and allows for new joint cartilage protection claims on product labels. The design of these two clinical trials reportedly marks the first evidence suggesting the biomarker, CTX-II, can be used to evaluate the chondroprotective efficacy of joint therapeutics in healthy individuals, as well as other populations.
Speaking on the 2018 trial, co-author Dr. Jason Theodosakis notes, “TX-II has already been utilized in research regarding disease joints. Our application into those with healthy joints opens up a new avenue for research in the musculoskeletal arena.”
“A future area of research could be performance enhancement. Another area would be long-term outcome studies, such as determining if NEM could inhibit or delay the future development of arthritis, medication use, or surgery. It’s known already, for instance, that quadriceps muscle weakness in women precedes the development of osteoarthritis. Theoretically, if we could keep people exercising, and their legs strong, they might be able to alter the course of history when it comes to joints.”
The market for ingredients that target joint and bone health is booming. Innova Market Insights data has shown that 7 percent of UK consumers used prescription medication for bone health in the past year, while 21 percent used prescription medication for joint health. The market researcher’s data have further shown that mobility is one of the top concerns for UK and US consumers, while products featuring mobility claims accounted for almost 17 percent of all supplements tracked globally between 2013 and 2017.
