A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Collavant4 n2 on Joint Function and Performance in Healthy, Active Male Adults With Exercise-induced Joint Discomfort

What this Trial Is About

Researchers are evaluating the effects of Collavant4 n2, a dietary supplement containing native type II collagen, on joint function, performance, and discomfort in healthy, physically active male amateur runners aged 40 to 65 years who experience exercise-induced knee discomfort. This randomized, double-blind, placebo-controlled study aims to compare Collavant4 n2 at a daily dose of 40 mg against a placebo over 24 weeks to understand its impact on knee joint discomfort and related outcomes. A total of 80 eligible male runners are randomly assigned to receive either Collavant4 n2 or placebo capsules once daily for 24 weeks. Participants must train regularly at least 150 minutes per week and have persistent knee discomfort after exercise but no diagnosed knee pathology like osteoarthritis. Assessments occur at baseline, 12 weeks, and 24 weeks to measure joint discomfort, pain intensity, physical performance, exertion, joint function, inflammation, and cartilage biomarkers. Throughout the study, participants are monitored for safety and tolerability through adverse event reports, vital signs, physical exams, lab tests, and quality-of-life questionnaires. The main outcome is the change in exercise-induced knee joint discomfort from baseline to week 24. Secondary outcomes include changes in pain before and after activity, time to pain recovery, physical performance, exertion, joint function and inflammation. The study concludes after 24 weeks of intervention with scheduled evaluations.

Effect of Collavant® n2 in Healthy Male Adults With Exercise-induced Joint Discomfort.