薬理と治療

Abstract

Objectives　A randomized, double-blind, placebo-controlled parallel-group study was conducted to evaluate the effectiveness of a food product containing fermented soybean extract for improving the cognitive function in healthy adults who were at least 40 years but less than 65 years of age. Methods　Cognitrax and MMSE as cognitive function tests, blood test, and a questionnaire on subjective symptoms were used to screen 131 healthy adults who were at least 40 years but less than 65 years of age and were aware of cognitive decline. Sixty adults who met all of the inclusion criteria and none of the exclusion criteria were selected as subjects. They were randomized to a group that consumed the food product containing fermented soybean extrac（t the fermented soybean extract group）or a group that consumed a placebo food product（the placebo group）. The subjects started consuming the assigned food product and visited our hospital to undergo the Cognitrax test and a questionnaire on subjective symptoms 6 weeks and 12 weeks after consuming the said food products. Results　One subject dropped out, and 59 completed the study. After excluding one subject, the effectiveness was analyzed in 28 subjects in the fermented soybean extract group and 30 subjects in the placebo group. No significant differences were found between the two groups after 6-week or 12-week consumption. However, the intragroup comparisons in the fermented soybean extract group revealed significant improvements after the food consumption in the “neurocognitive index,”“composite memory,”“verbal memory,”“cognitive flexibility,”“processing speed,”and“executive function”scores of Cognitrax compared with scores before the food consumption. Regarding the safety, no serious adverse events or adverse food reactions attributable to the consumption of the test product occurred, but intergroup differences within physiological variations were noted in some blood test items. Conclusion　A randomized, double-blind, placebo-controlled parallel-group study was conducted to evaluate cognitive improvements resulting from the consumption of a food product containing fermented soybean extract. The results showed that cognitive function measures were improved after the food consumption compared with those before the consumption in the fermented soybean extract group. （UMINID: UMIN000043602） （Jpn Pharmacol Ther 2022；50：1467‒86）