Randomized Study of Agar-Agar and Collagen Supplements for Knee Joint Pain Relief in Adults Aged 40 to 70

What this Trial Is About

Researchers are investigating the effects of agar-agar, undenatured type II collagen UC-II, and their combination on knee joint pain in adults aged 40 to 70 with mild to moderate joint pain but without an osteoarthritis diagnosis. This study aims to assess improvements in pain, stiffness, functional capacity, and overall knee health using the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC. The trial is randomized, placebo-controlled, triple-blind, and parallel-group in design, involving 80 participants. Participants are randomly assigned to one of four groups to receive daily capsules for 12 weeks agar-agar alone, agar-agar combined with UC-II, UC-II alone, or placebo. Each supplement and placebo is given in capsule form with precise dosing 2.4 g of agar-agar, 40 mg of UC-II plus 2.4 g maltodextrin for the UC-II group, or 2.4 g maltodextrin for placebo. The study includes a pre-screening visit, a baseline visit to start treatment, a mid-study telephone follow-up, and an end-of-study visit. The total participation duration is 13 weeks. During the study, participants will undergo assessments of knee pain, stiffness, functional capacity, and range of motion at baseline, 6 weeks, and 12 weeks. Additional evaluations include hand joint assessments, medication use, inflammatory and collagen metabolism blood markers, body composition, dietary intake, physical activity, safety monitoring, and treatment adherence. The primary outcome is the change in knee joint pain perception measured by the WOMAC Pain subscale throughout the treatment period.

Effect of Agar/Collagen-based Compounds on Osteoarticular Pain: Randomized Triple-blind Clinical Trial