薬理と治療

Abstract

Objective　To examine the effects of foods containing broccoli extract（Brolico）on the immune function in healthy Japanese adults. Methods　In this randomized, placebo-controlled, double-blind, parallel-group comparison study, subjects were randomly assigned to the Brolico group or the placebo group using a computerized random number generator（n＝50 each）. Subjects took six tablets of Brolico or placebo at breakfast for 8 weeks. Evaluation items included common cold symptoms, immune function, and SF-36. Results　The efficacy analysis data were set as a per-protocol set for 47 subjects in the Brolico group and 49 in the placebo group because four subjects withdrew from the study for personal reasons in the intervention period. The primary outcome, the cumulative number of days of common cold symptoms per study subject during the study period was significantly lower in the Brolico group than in the placebo group. Furthermore, the number of total days and cumulative days of common cold symptoms per group during the study period and the ratio of cumulative days of common cold symptoms to total days were significantly lower in the Brolico group than in the placebo group. Moreover, the Brolico group showed significantly higher CD8＋CD28＋T-cell count scores in the immune function test compared with the placebo group, and the CD8＋CD28＋T-cell counts were marginally higher in the Brolico group than in the placebo group. The consumption of the test food had no significant adverse effects. Conclusions　These results revealed that Brolico consumption affects the immune function and reduces common cold symptoms in healthy Japanese adults. Trial registration　UMIN000044913 Foundation　Imagine Global Care Corp （Jpn Pharmacol Ther 2022；50：1065‒78）