薬理と治療

Abstract

Objectives To evaluate the safety of excessive consumption of alpha-linolenic acid-enriched diacylglycerol（ALA-DAG）. Methods A randomized, double-blind controlled, parallel-group study in 60 healthy subjects. The subjects were randomly allocated to two groups, and ingested either control triacylglycerol （TAG; rapeseed oil）or ALA-DAG at three times the effective dose（2.50 g/d）against visceral obesity（7.50 g/d）for 4 wk. Safety parameters were assessed at the 0, 2, and 4-wk time points. Results All subjects（n＝30/group）completed the study, and were included in the intention-to-treat（ITT）samples. No adverse events associated with consumption of ALA-DAG were observed in endocrine-related factors, fat-soluble vitamins, coagulation-related factors, or other general safety parameters, such as blood biochemistries, hematology, and urinary analyses in the ITT samples. Conclusions The results suggest that the excessive consumption of dietary ALA-DAG is safe in healthy subjects.