Undenatured type II collagen (UC-II®) for joint support: a randomized, double-blind, placebo-controlled study in healthy volunteers

Abstract

Background: UC-II contains a patented form of undenatured type II collagen derived from chicken sternum. Previous preclinical and clinical studies support the safety and efficacy of UC-II in modulating joint discomfort in osteoarthritis and rheumatoid arthritis. The purpose of this study was to assess the efficacy and tolerability of UC-II in moderating joint function and joint pain due to strenuous exercise in healthy subjects.

Methods: This randomized, double-blind, placebo-controlled study was conducted in healthy subjects who had no prior history of arthritic disease or joint pain at rest but experienced joint discomfort with physical activity. Fifty-five subjects who reported knee pain after participating in a standardized stepmill performance test were randomized to receive placebo (n = 28) or the UC-II (40 mg daily, n = 27) product for 120 days. Joint function was assessed by changes in degree of knee flexion and knee extension as well as measuring the time to experiencing and recovering from joint pain following strenuous stepmill exertion.

Results: After 120 days of supplementation, subjects in the UC-II group exhibited a statistically significant improvement in average knee extension compared to placebo (81.0 ± 1.3º vs 74.0 ± 2.2º; p = 0.011) and to baseline (81.0 ± 1.3º vs 73.2 ± 1.9º; p = 0.002). The UC-II cohort also demonstrated a statistically significant change in average knee extension at day 90 (78.8 ± 1.9º vs 73.2 ± 1.9º; p = 0.045) versus baseline. No significant change in knee extension was observed in the placebo group at any time. It was also noted that the UC-II group exercised longer before experiencing any initial joint discomfort at day 120 (2.8 ± 0.5 min, p = 0.019), compared to baseline (1.4 ± 0.2 min). By contrast, no significant changes were seen in the placebo group. No product related adverse events were observed during the study. At study conclusion, five individuals in the UC-II cohort reported no pain during or after the stepmill protocol (p = 0.031, within visit) as compared to one subject in the placebo group.

Conclusions: Daily supplementation with 40 mg of UC-II was well tolerated and led to improved knee joint extension in healthy subjects. UC-II also demonstrated the potential to lengthen the period of pain free strenuous exertion and alleviate the joint pain that occasionally arises from such activities.

Figure 1

Sequence of study procedures at a typical clinic visit.

Figure 2

Knee extension as measured by goniometry. Values are presented as Mean ± SEM. *p ≤ 0.05 indicates a statistically significant difference versus baseline or placebo. Number of completers: n = 24 in UC-II group (n = 3 dropouts); n = 20 in placebo group (n = 6 dropouts; n = 2 did not participate in ROM assessment).

Figure 3

Impact of stepmill procedure on the onset of pain. Values are presented as Mean ± SEM. *p ≤ 0.05 indicates a statistically significant difference from baseline. Number of completers: n = 19 in UC-II group (n = 3 dropouts; n = 5 did not have pain); n = 20 in placebo group (n = 6 dropouts; n = 1 did not have pain; n = 1 did not use stepmill).

Figure 4

Percent change in time to complete recovery from pain. Values are presented as Mean ± SEM. *p ≤ 0.05 indicates a statistically significant difference from baseline. Number of completers: n = 18 in UC-II group (n = 3 dropouts; n = 5 did not have pain; n = 1 time to complete recovery from pain was not achieved); n = 20 in placebo group (n = 6 dropouts; n = 1 did not have pain; n = 1 did not use stepmill).