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Stratum Nutrition announced a new progressive joint health clinical trial evaluating the firm’s joint health ingredient NEM, a branded eggshell membrane.
Stratum Nutrition (Carthage, MO) announced a new progressive joint health clinical trial evaluating the firm’s joint health ingredient NEM, a branded eggshell membrane. Conducted on an exercising, healthy population, the trial is an expanded follow-up to Stratum’s 2018 trial1 on healthy post-menopausal women. The previous study found that 500 mg of the eggshell membrane improved recovery from exercise-induced joint pain and stiffness, and significantly reduced discomfort immediately following exercise. The 2018 trial also demonstrated a chondroprotective effect from supplementation with NEM through a lasting decrease in CTX-II, a cartilage degradation biomarker.
The new trial has a larger population of 84 subjects – versus 60 in the previous trial – and the demographic includes both men and women between the ages of 40 and 75. It will further investigate the changes in CTX-II in exercising individuals to support new joint cartilage protection claims on product labels. “With this ongoing study, we intend to satisfy both FDA’s and FTC’s strong preference for two randomized controlled trials to substantiate labeling and advertising claims,” said Kevin J. Ruff PhD, MBA, CCRP, senior director of scientific and regulatory affairs for Stratum Nutrition, in a press release. “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.”
1. Ruff KJ et al. “Beneficial effects of natural eggshell membrane versus placebo in exercise-induced joint pain, stiffness, and cartilage turnover in healthy, postmenopausal women.” Clinical Interventions in Aging, vol. 13 (2018): 285-295