ISSN: 2329-9096
Kevin J. Ruff1*, Kayce M. Morton2, Sarah A. Duncan2, Mathew Back1
Background: Exercise provides countless benefits, including better sleep, enhanced physical function, healthier body weight, as well as a reduced risk of a number of chronic diseases. Despite these well-studied benefits, participation rates in physical activity in much of the westernized world remain low. This study was designed to evaluate whether NEM® brand eggshell membrane would reduce cartilage turnover or alleviate joint pain or stiffness, some of the major barriers to participation, either directly following exercise or 12 hours’ post-exercise, in healthy men and women versus placebo.
Methods: Eighty-five healthy, men and women (aged 40-72) were randomly assigned to receive either oral NEM® 500 mg (n=43) or placebo (n=42) once daily for two weeks while performing an exercise regimen (40 to 100 steps per leg) on alternating days. The primary endpoint was any statistically significant reduction in exerciseinduced cartilage turnover via the biomarker c-terminal cross-linked Telopeptide of Type-II collagen (CTX-II) versus placebo, evaluated at 1 week and 2 weeks of treatment. Secondary endpoints were any reductions in either exercise-induced joint pain or stiffness versus placebo, evaluated daily, via participant questionnaire. The clinical assessment was performed on the per protocol population.
Findings: Supplementation with NEM® produced a significant absolute treatment effect (TEabs) versus placebo after both one week (TEabs -19.2%, p=0.008) and two weeks of exercise (TEabs -18.8%, p=0.031) for the primary endpoint, CTX-II. Rapid treatment responses were observed for both immediate pain (p=0.004 versus placebo) and stiffness (p=0.028) with results occurring as early as Day 1 and Day 5, respectively. Recovery pain and stiffness were not significantly different from placebo, despite the fact that recovery pain (Day 14, TEabs -27.6%) had returned to resting levels and recovery stiffness (Day 14, TEabs -18.2%) had fallen below resting levels for the NEM® treatment group. There were no serious adverse events reported during the study and the treatment was reported to be well tolerated by study participants.
Conclusion: NEM® brand eggshell membrane, 500 mg once daily, rapidly improved exercise-induced joint pain (Day 1) and stiffness (Day 5). Moreover, a substantial chondroprotective effect was demonstrated from supplementation with NEM® through a lasting decrease in the cartilage degradation biomarker CTX-II. Reducing pain and stiffness from exercise and the concern of damaging cartilage is tantamount to reducing these major barriers to participation in increased physical activity and exercise. The Clinical Trial Registration number for this study is: NCT03679923.