薬理と治療

Abstract

Objective　To verify the effects of Lactiplantibacillus plantarum TWK10(mentioned as TWK10 hereafter)on muscle and body fat in healthy middle–aged Japanese. Methods　This was a randomized, double–blind, placebo–controlled, parallel–group comparative study. Among 119 individuals who provided informed consent, 56 participants(aged 40–64 years)who met the eligibility criteria were randomly assigned to two groups(allocation ratio 1:1)using a computer: a group consuming the test food containing either sterilized TWK10 powder(at least 300×108 cells/day; TWK10 group)or placebo(placebo group). Participants were instructed to consume one capsule of either food daily for 12 weeks. The evaluation parameters were physical measurements, including body composition, and visceral fat area, subcutaneous fat area, and total fat area in transverse section of umbilical region, as measured using X–ray and computer tomography scan. The primary outcome was lean body mass after the 12–week intervention. Results　The analysis included 53 participants(26 and 27 in the TWK10 and placebo groups, respectively);3 participants were excluded for noncompliance. Following the 12–week intervention, the lean body mass and muscle mass(whole body and trunk)in the TWK10 group were significantly higher than those in the placebo group. In the subgroup aged≥50 years, the lean body and muscle mass were significantly higher, and the body fat percentage in the TWK10 group tended to be lower than that in the placebo group. No adverse events were observed. Conclusions　These results suggest that consuming TWK10 can help maintain muscle mass in healthy middle–aged Japanese, and reduce body fat especially in those aged≥50 years. Trial registration　UMIN000050371 Foundation　Nakahara Co., Ltd.(Jpn Pharmacol Ther 2024;52:833‒46)