Efficacy and Tolerability of an Undenatured Type II Collagen Supplement in Modulating Knee Osteoarthritis Symptoms: A Multicenter Randomized, Double-Blind, Placebo-Controlled Study

Nutr J. 2016 Jan 29;15:14. doi: 10.1186/s12937-016-0130-8.

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 .

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Biomarkers / blood
  • Body Mass Index
  • Body Weight
  • C-Reactive Protein / metabolism
  • Cartilage Oligomeric Matrix Protein / blood
  • Collagen Type II / administration & dosage*
  • Dietary Supplements*
  • Double-Blind Method
  • Female
  • Humans
  • Interleukin-6 / blood
  • Male
  • Matrix Metalloproteinase 3 / blood
  • Middle Aged
  • Osteoarthritis, Knee / drug therapy*
  • Pain Measurement
  • Treatment Outcome

Substances

  • Biomarkers
  • COMP protein, human
  • Cartilage Oligomeric Matrix Protein
  • Collagen Type II
  • Interleukin-6
  • C-Reactive Protein
  • MMP3 protein, human
  • Matrix Metalloproteinase 3

Associated data

  • CTRI/CTRI/2013/02/003348
  • CTRI/CTRI/2013/05/003663