薬理と治療

Abstract

A placebo-controlled, randomized, parallel-group, double-blind human clinical study was performed in 90 healthy mid- to senior age adults. Participants were orally administered a placebo or a composite dietary supplement containing propolis extract, Gingko biloba extract, phosphatidylserine and curcumin（active）for 12 weeks. Cognitive function evaluated by MCI screening and Cognitrax, and various blood or urine markers were measured at pre- and post-administration. Data from 82 subjects（placebo 40, active 42）who completed the study and were eligible were analyzed. Compared to the placebo group, the active group showed significant improvement in Stroop（ST）commission errors which indicate attention, concentration, and judging ability in Cognitrax; MPI score which is an indicator of verbal memory and attention in MCI screen; and three immediate recall task score in MCI screen. Blood levels of TNF-α and AST were lowered, and subjective symptoms of sleep quality and Social Functioning in SF-36 were significantly improved compared to placebo. Furthermore, Cognitrax scores from 20 subjects whose BDNF were less than the first quartile were analyzed. Compared to the placebo group, the active group showed a significant improvement in neurocognitive index which is the total score, as well as indications for attention, concentration, and judgment, namely“, cognitive flexibility, executive function and Shifting attention（SAT）correct response”. No severe adverse events were observed in any of the groups. This study demonstrates that the intake of composite dietary supplement safely improves cognitive functions, such as verbal memory, attention, concentration, and judgement, sleep quality and liver function through anti-inflammation. （UMIN 000038465）