Evaluation of the Efficacy and Safety of CollaSel PRO® Type I and Type III Hydrolyzed Collagen Peptides in the Treatment of Osteoarthritis: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial.

Objectives

This study aims to evaluate the efficacy and safety of oral supplementation with hydrolyzed collagen peptides (HCP) type I and type III (CollaSel PRO®) in reducing joint pain and stiffness and improving physical function in patients with osteoarthritis (OA).

Methods

In this randomized, double-blind, placebo-controlled trial (ClinicalTrials.gov Identifier: NCT05369780; approved by the Institutional Review Board), 160 adult patients with OA (mean age 52.4 ± 4.3 years; 111 females, 49 males) were randomly assigned to receive either 10 g/day of CollaSel PRO® (n = 80) or placebo (maltodextrin, n = 80) for 8 weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used to evaluate knee and hip joints, and the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS-AHFS) was used for ankle joints. Assessments were conducted at baseline and at weeks 1, 4, and 8.

Results

In the CollaSel PRO® group, a significant decrease in WOMAC scores (mean ± SD 50.5 ± 17.0, 40.7 ± 16.9 and 33.8 ± 16.5 vs. 53.7 ± 16.9, respectively, p < 0.001 for each) and significant increase in AOFAS-AHFS scores (64.2 ± 13.1, 73.6 ± 12.3 and 80.8 ± 9.9 vs. 61.8 ± 13.9, respectively, p < 0.001 for each) were noted at weeks 1, 4, and 8 compared to the baseline scores. WOMAC scores were significantly lower in comparing HCP and placebo, and AOFAS-AHFS scores were higher in the HCP group compared to the placebo group at weeks 4 and 8 (all p < 0.001).

Conclusions

CollaSel PRO® appears to be a safe and effective option for the symptomatic management of osteoarthritis. It significantly improved joint pain, stiffness, and physical function in multiple joints. These improvements are not only statistically significant but also clinically meaningful, supporting the need for longer-term evaluation.