Efficacy and Safety of TurmXTRA® 60N in Delayed Onset Muscle Soreness in Healthy, Recreationally Active Subjects: A Randomized, Double-Blind, Placebo-Controlled Trial

Abstract

Background. Delayed onset of muscle soreness (DOMS) and its physiological consequences influenced an individual's adherence to an exercise routine. Objective. This study aimed to evaluate the efficacy, safety, and tolerability of TurmXTRA® 60N (WDTE60N) on DOMS compared to placebo in recreationally active healthy subjects. Methods. This randomized, double-blind, placebo-controlled parallel-group study enrolled 30 healthy and recreationally active subjects (average age: 28.23 ± 4.20 years) and randomized them to receive WDTE60N (WDTE60N group; n = 15) or placebo (placebo group; n = 15). Study treatments were initiated 29 days before the eccentric exercise and were continued for 4 days after the exercise. The primary endpoint was the change in pain intensity measured by the visual analog scale (VAS) at the end of study treatment (at 96 hours after eccentric exercise) from baseline (measured immediately after exercise). Results. The VAS score indicated that subjects from the WDTE60N group reported significantly less pain after eccentric exercise compared to the placebo group (AUC0-96h: 286.8 ± 46.7 vs. 460 ± 40.5, respectively; p<0.0001). Well-being status was assessed using the adapted version of the Hooper and MacKinnon questionnaire and was calculated as individual and cumulative scores of the domains (fatigue, mood, general muscle soreness, sleep quality, and stress) that demonstrated improvement in all domains and in overall well-being in the WDTE60N group compared to the placebo group (p<0.0001). Serum lactate dehydrogenase (LDH) was significantly lower in the WDTE60N group compared to the placebo group (AUC0-96h: 23623.7 ± 2532.0 vs. 26138.6 ± 3669.5, respectively; p=0.0446). Conclusion. Intake of WDTE60N before and after eccentric exercise significantly reduced subjective perception of muscle soreness and serum LDH activity and increased the psychological well-being in recreationally active subjects.