02.14.19
Stratum Nutrition, unveiled a progressive joint health clinical trial underway evaluating the triple-action joint health ingredient, NEM eggshell membrane. 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].
These back-to-back, healthy population exercising studies are evaluating whether NEM would 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.
This new trial includes 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.
The unique, 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. This 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 PhD, MBA, CCRP – Sr. Director of Scientific & Regulatory Affairs for Stratum Nutrition –commented on the new study, “With this ongoing study, we intend to satisfy both 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.”
These back-to-back, healthy population exercising studies are evaluating whether NEM would 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.
This new trial includes 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.
The unique, 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. This 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 PhD, MBA, CCRP – Sr. Director of Scientific & Regulatory Affairs for Stratum Nutrition –commented on the new study, “With this ongoing study, we intend to satisfy both 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.”
