薬理と治療

Abstract

Objective　To examine the effects of foods containing sweet potato shochu lees extract with fat-soluble polyphenols（FSPs）on cognitive function in healthy Japanese adults. Methods　In this randomized, placebo-controlled, double-blind, parallel-group comparison study, twenty-two participants were randomly assigned to the FSP group or the placebo group using a computerized random number generator. One tablet of the test food that contained FSPs or placebo was taken daily with water at breakfast for 12 weeks. Evaluation items included cognitive function tests using Cognitrax, mood symptom assessment using the Japanese version of Profile of Mood States（2nd edition）, subjective cognitive function symptoms, and cognitive function-related biomarkers. Results　The efficacy analysis dataset was a per-protocol set（PPS）, and 20 participants per group were included in the analysis. Although there was no significant difference in the primary outcome of total memory between the two groups after the intervention, the FSP group showed a significant improvement in visual memory, which is a part of total memory, and other cognitive domains related to social cognition. In the womenʼs subgroup analysis, significant improvements were observed in the domains related to the neurocognitive index, total memory, total attention, and in the items that showed significant differences in the PPS. As for blood amyloid-β（Aβ）, analysis of the subgroup of the study subjects whose Aβ was below the mean value during the screening test showed the FSP group significantly suppressed increasing Aβ. The consumption of the test foods had no significant adverse effects. Conclusions　The 12-week intake of foods containing FSPs derived from sweet potato shochu dregs improved some cognitive functions in healthy Japanese adults. Trial registration　UMIN000041291 Foundation　Strategic Core Technology Advancement Program（Supporting Industry Program） and Satsuma Shuzo Co. Ltd.