薬理と治療

Abstract

Objective　This study aimed to examine the effect of food containing matured red ginseng extract（MRGE）on fatigue and stress in healthy Japanese adults who complain of tiredness in daily life. Methods　Twenty-eight participants were randomly divided into two groups using a computer. One group consumed two tablets of the test food（MRGE-containing food）and the other consumed placebo with water at any time for 12 weeks. The evaluation items included fatigue assessment using the visual analogue scale, mood symptom assessment using the Profile of Mood States（second edition）, autonomic nerve function test, oxidative stress-related biomarkers, and subjective symptom assessment using the Likert scale. Furthermore, the Uchida-Kleppelin test was performed as a workload, and each evaluation（except for some items）was performed before and after the workload. Results　The efficacy analysis data set was per protocol set, including 28 subjects from the MRGE and 26 from the placebo groups. The primary outcome of subjective fatigue assessment before and after workload significantly improved, and the sympathetic and parasympathetic nerves were activated in the MRGE group compared with the placebo group. Additionally, the overall autonomic function of the MRGE group improved extensively, approaching that of actual age. Among the subgroups, those with women only and those with subjects aged ≥43 years, respectively showed an improvement in oxidative stress indicators. No adverse events or side effects induced by the test foods were observed. Conclusions　The 12-week intake of MRGE-containing food reduced temporary subjective fatigue and alleviated mental stress through adjustment of autonomic nerve function in healthy Japanese adults who feel tired in daily life. Trial registration　UMIN000042442 Foundation　KIMʼs Korean Ginseng Co., Ltd.