薬理と治療

Abstract

Objective　This study aimed to investigate the effects of a test food on healthy Japanese subjects with knee joint discomfort. Methods　A total of 66 healthy, disease-free Japanese subjects experiencing discomfort in the knee joint participated in a randomized, double-blinded, placebo-controlled study from July2018-April 2019. All subjects were randomly allocated into the intervention or the placebo group（n＝33 in each group）using a computerized random-number generator. Each group was administered with six tablets［active（containing test food）or placebo］daily for 12 weeks. The total score of Japanese Knee Osteoarthritis Measure（JKOM; primary outcome）, other parameters of JKOM, the Japanese Orthopaedic Association score for osteoarthritic knees, and subjective symptoms related to knee pain were assessed, and 30-second chair stand test, 10-meter walking test, blood test, and safety assessments were performed. Results　At 12 weeks after ingestion of tablets, the total score of JKOM for the intervention group exhibited a significant decrease compared with the placebo group（P＝0.006）. In addition, consumption of the test food significantly reduced the subjective symptoms of discomfort in the knee joint associated with standing and sitting, ascending and descending the stairs, and changing clothes（P＜0.050）. No safety concerns were noted. Conclusions　The consumption of test food containing glucosamine hydrochloride, methylsulfonylmethane, boswellia serrata extract, and olive extract for 12 weeks resulted in the relief from the discomfort in the knee joint in healthy Japanese subjects. Trial Registration　UMIN-CTR: UMIN000033446Funding　DHC Corporation