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Randomized Controlled Trial
. 2016 Jan 29:15:14.
doi: 10.1186/s12937-016-0130-8.

Efficacy and tolerability of an undenatured type II collagen supplement in modulating knee osteoarthritis symptoms: a multicenter randomized, double-blind, placebo-controlled study

James P Lugo  1 , Zainulabedin M Saiyed  2 , Nancy E Lane  3
Affiliations
Randomized Controlled Trial

Efficacy and tolerability of an undenatured type II collagen supplement in modulating knee osteoarthritis symptoms: a multicenter randomized, double-blind, placebo-controlled study

James P Lugo et al. Nutr J. .

Abstract

Background: Undenatured type II collagen (UC-II) is a nutritional supplement derived from chicken sternum cartilage. The purpose of this study was to evaluate the efficacy and tolerability of UC-II for knee osteoarthritis (OA) pain and associated symptoms compared to placebo and to glucosamine hydrochloride plus chondroitin sulfate (GC).

Methods: One hundred ninety one volunteers were randomized into three groups receiving a daily dose of UC-II (40 mg), GC (1500 mg G & 1200 mg C), or placebo for a 180-day period. The primary endpoint was the change in total Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) from baseline through day 180 for the UC-II group versus placebo and GC. Secondary endpoints included the Lequesne Functional Index (LFI), the Visual Analog Scale (VAS) for pain and the WOMAC subscales. Modified intent-to-treat analysis were performed for all endpoints using analysis of covariance and mixed model repeated measures, while incremental area under the curve was calculated by the intent-to-treat method.

Results: At day 180, the UC-II group demonstrated a significant reduction in overall WOMAC score compared to placebo (p = 0.002) and GC (p = 0.04). Supplementation with UC-II also resulted in significant changes for all three WOMAC subscales: pain (p = 0.0003 vs. placebo; p = 0.016 vs. GC); stiffness (p = 0.004 vs. placebo; p = 0.044 vs. GC); physical function (p = 0.007 vs. placebo). Safety outcomes did not differ among the groups.

Conclusion: UC-II improved knee joint symptoms in knee OA subjects and was well-tolerated. Additional studies that elucidate the mechanism for this supplement's actions are warranted.

Trial registration: CTRI/2013/05/003663 ; CTRI/2013/02/003348 .

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Figures

Fig. 1
Fig. 1
Enrollment and randomization flow chart
Fig. 2
Fig. 2
Total WOMAC score (a), Mean VAS (b), Total LFI (c) in the UC-II, GC and placebo groups over the 180-day study period. Values are presented as mean ± SE. *Significant difference between the UC-II (n = 54) and the placebo (n = 53) group, p < 0.05. †Significant difference between the UC-II (n = 54) and the GC group (n = 57), p < 0.05
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