title: Efficacy and tolerability of an undenatured type II collagen supplement in modulating knee osteoarthritis symptoms: a multicenter randomized, double-blind, placebo-controlled study.
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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  CTRI/2013/05/003663 ; CTRI/2013/02/003348 .
authors.affiliation: InterHealth Nutraceuticals, Benicia, CA, USA. jlugo@interhealthusa.com.
authors.forename: James P
authors.initials: JP
authors.lastname: Lugo
authors.affiliation: InterHealth Nutraceuticals, Benicia, CA, USA. zsaiyed@interhealthusa.com.
authors.forename: Zainulabedin M
authors.initials: ZM
authors.lastname: Saiyed
authors.affiliation: Center for Musculoskeletal Health, University of California Davis Health System, 4625 2nd Avenue, Suite 2006, Sacramento, CA, 95817, USA. nelane@ucdavis.edu.
authors.forename: Nancy E
authors.initials: NE
authors.lastname: Lane
mesh_terms: D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood; D015992:Body Mass Index; D001835:Body Weight; D002097:C-Reactive Protein / Q000378:metabolism; D064236:Cartilage Oligomeric Matrix Protein / Q000097:blood; D024043:Collagen Type II / Q000008:administration & dosage*; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015850:Interleukin-6 / Q000097:blood; D008297:Male; D019278:Matrix Metalloproteinase 3 / Q000097:blood; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D010147:Pain Measurement; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D002097:C-Reactive Protein; D064236:Cartilage Oligomeric Matrix Protein; D024043:Collagen Type II; D015850:Interleukin-6; D019278:Matrix Metalloproteinase 3; C511768:MMP3 protein, human; C577553:TSP5 protein, human
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