薬理と治療

Abstract

Objectives This trial was conducted to investigate whether intake of undenatured type Ⅱ and Ⅺ collagen derived from salmon nasal cartilage can ameliorate discomfort in the knee joints in healthy individuals. Methods　In a randomized, double–blind, placebo–controlled, intergroup trial, the subjects were randomly allocated to receive a 10 mg/day of undenatured collagen or placebo for 16 weeks. The primary outcomes included visual analogue scale（VAS）scores in five different situations. The secondary outcomes were scores on 10–time–repeated exercise tests and the levels of type Ⅱ collagen degradation/synthesis biomarkers—CPⅡ, CTX–Ⅱ, and C1, 2C. Results　Each group consisted of 25 subjects. After the 16 weeks, there was a significant difference in changes from baseline in the VAS score at walking between the undenatured collagen group and the placebo group（P＝0.04）. Hierarchical analyses for the subjects ≥50 years of age（excluding those with no pain or strong discomfort at week 0）indicated the efficacy of undenatured collagen with between–group differences in changes in VAS scores at going up and down stairs（P＝0.01）and in the squat scores of 10–time–repeated exercise tests（P＝ 0.04）. A CTX–Ⅱ/CPⅡ ratio also showed a between–group difference（P＝0.04）. Conclusions　This trial showed that the intake of undenatured collagen derived from salmon nasal cartilage can ameliorate and prevent discomfort in the knee joints at walking, as well as discomfort caused by bending and stretching of the knee joints, such as using stairs and doing squat, in persons 50 years of age or older. This efficacy was supported by the results of biomarker assessment and was suggested to be resulted from normalization of the balance of synthesis and degradation of the joint cartilage.（UMIN ID: UMIN000041641）（Jpn Pharmacol Ther 2023；51：909‒20）