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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.NJ

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 .

Authors+Show Affiliations

InterHealth Nutraceuticals, Benicia, CA, USA. jlugo@interhealthusa.com.InterHealth Nutraceuticals, Benicia, CA, USA. zsaiyed@interhealthusa.com.Center for Musculoskeletal Health, University of California Davis Health System, 4625 2nd Avenue, Suite 2006, Sacramento, CA, 95817, USA. nelane@ucdavis.edu.

Pub Type(s)

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

Language

eng

PubMed ID

26822714

Citation

Lugo, James P., et al. "Efficacy and Tolerability of an Undenatured Type II Collagen Supplement in Modulating Knee Osteoarthritis Symptoms: a Multicenter Randomized, Double-blind, Placebo-controlled Study." Nutrition Journal, vol. 15, 2016, p. 14.
Lugo JP, Saiyed ZM, Lane NE. 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;15:14.
Lugo, J. P., Saiyed, Z. M., & Lane, N. E. (2016). Efficacy and tolerability of an undenatured type II collagen supplement in modulating knee osteoarthritis symptoms: a multicenter randomized, double-blind, placebo-controlled study. Nutrition Journal, 15, 14. https://doi.org/10.1186/s12937-016-0130-8
Lugo JP, Saiyed ZM, Lane NE. 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. PubMed PMID: 26822714.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and tolerability of an undenatured type II collagen supplement in modulating knee osteoarthritis symptoms: a multicenter randomized, double-blind, placebo-controlled study. AU - Lugo,James P, AU - Saiyed,Zainulabedin M, AU - Lane,Nancy E, Y1 - 2016/01/29/ PY - 2015/11/07/received PY - 2016/01/20/accepted PY - 2016/1/30/entrez PY - 2016/1/30/pubmed PY - 2016/10/21/medline SP - 14 EP - 14 JF - Nutrition journal JO - Nutr J VL - 15 N2 - 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 . SN - 1475-2891 UR - https://www.unboundmedicine.com/medline/citation/26822714/Efficacy_and_tolerability_of_an_undenatured_type_II_collagen_supplement_in_modulating_knee_osteoarthritis_symptoms:_a_multicenter_randomized_double_blind_placebo_controlled_study_ L2 - https://nutritionj.biomedcentral.com/articles/10.1186/s12937-016-0130-8 DB - PRIME DP - Unbound Medicine ER -