薬理と治療

Abstract

Objective　This study verified the effects of a single dose of a tablet supplement containing Terminalia bellirica and banaba leaf extracts on postprandial blood triglycerides and glucose in healthy Japanese subjects. Methods　We conducted a randomized, double-blind, placebo-controlled, crossover trial from June 24 to October 21, 2019. Thirty︱six healthy Japanese adult subjects were randomly allocated into sequence 1 or 2（n＝18 each）using a computerized random number generator. The subjects consumed a single dose of either the test food or placebo during periods 1 and 2 with a washout period exceeding one week. The loading diet was ingested after consuming the test food or placebo. The levels of postprandial blood triglycerides and glucose were set as primary outcomes, while the measurement of blood levels of insulin, HOMA-β, HOMA-R, and remnant-like particle cholesterol were set as secondary outcomes. Results　The number of subjects finally analyzed as per-protocol dataset was 18 from sequence 1（8 men and 10 women）and 16 from sequence 2（6 men and 10 women）. The postprandial blood triglyceride level at 240 min after the loading and the maximum concentration of postprandial blood glucose showed a significant group-time interaction, and both items after consumption of the test food were lower than that of placebo（P＜0.05）. No safety concerns were noted. Conclusions　A single dose of the test food significantly inhibited the increase in postprandial blood triglycerides and glucose.Trial registration　UMIN000036678 Foundation　DHC Corporation