Stratum Nutrition®, the Global Leader of eggshell and eggshell membrane wellness ingredients, announces a progressive joint health clinical trial underway evaluating the triple-action joint health ingredient, NEM®. This trial is being conducted in an exercising, healthy population and is an expanded follow-up trial to Stratum’s 2018 healthy post-menopausal women trial. [Clin Interv Aging. 2018 Feb 19;13:285-295. doi: 10.2147/CIA.S153782]
These back-to-back, healthy population studies evaluated whether NEM® supplementation could reduce exercise-induced cartilage turnover and/or alleviate joint pain and stiffness. The previous 2018 study found that a once daily, 500 mg dose of NEM® rapidly reduced discomfort immediately following exercise and improved recovery throughout a 12-hour post-exercise time period. A substantial chondroprotective effect was also demonstrated from NEM® supplementation through a lasting decrease in the cartilage degradation biomarker, CTX-II.
This new trial included a larger population, (84 subjects vs 60 in the prior trial), as well as a demographic of both men and women ages 40-75. The women in this study were not required to be post-menopausal, as was the case in the previously published study. As before, subjects were truly healthy and could not have had persistent knee or ankle pain while at rest in order to participate.
Both studies utilized a unique, patented trial design that looks at changes in a cartilage degradation biomarker (CTX-II) in healthy exercising individuals. A reduction in urine or serum CTX-II levels provides substantiation for new joint cartilage protection claims on product labels. The design of these two clinical trials 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.
Kevin J. Ruff Ph.D., MBA, CCRP – Sr. Director of Scientific & Regulatory Affairs for Stratum Nutrition –comments on the new study, “With this ongoing study, we intend to satisfy both FDA’s and FTC’s strong preference for 2 randomized controlled trials (RCTs) to substantiate labeling and advertising claims. Both RCTs were conducted in healthy exercising populations, giving brand marketers access to meaningful claims that will resonate with end-consumers.”
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