薬理と治療

Abstract

Objective　We examined the effects of an ethanol/water extract of olive leaves （EEO, trade name: OleaVita®）, which has a fat-reducing effect, on human energy metabolism. Methods　A randomized, placebo-controlled, double-blind, parallel-group comparison study was conducted from February to April 2019 in healthy Japanese adults with a body mass index of≥23 to＜30 without an excessive daily exercise routine. The subjects were randomly assigned to an EEO or placebo group （n＝20 per group）and each group took either one EEO capsule（OleaVita®）or placebo capsule daily for 8 weeks. The primary outcomes were body weight, waist diameter, fatigue visual analog scale（VAS）, and respiratory quotient（RQ）. Results 　The final efficacy analysis involved 19 subjects each in the EEO and placebo groups. In the subgroup analysis, the subjects in a per-protocol se（t PPS）whose low-density lipoprotein cholesterol level at screening was≤139 mg/dL were extracted. The PPS revealed no significant differences between groups. In the subgroup analysis, the change in RQ between the rest time and after the 30-min-exercise-load in the EEO group was significantly lower than that in the placebo group at 8 weeks after intake（P＝0.008）. No adverse events attributable to the test food were observed. Conclusions　The results suggest that continuous intake of an EEO for 8 weeks increases fat-burning efficiency. Clinical trial registration number　UMIN-CTR: UMIN000035750. Funder　Nutrition Act Co., Ltd.