エンジュポリフェノール（酵素処理イソクエルシトリン）配合飲料の肥満者を含む健康成人に対する過剰摂取時の安全性

Objective A double−blind placebo−controlled study for 4 weeks was conducted on 48 subjects to evaluate the safety of the drink containing Japanese pagoda tree polyphenol （enzymatically modified isoquercitrin）in the case of excessive intake in healthy adults include obesity persons. Methods Healthy adults include obesity persons（male＝24, female＝24, mean 36.6±10.0 years old, mean 24.8±2.9 BMI）were randomly divided into two groups, one is test group and the other is placebo group. The test group ingested daily 3 bottles of test drink（350 mL／bottle, total 1050 mL）, which is equal to three times as much as regular amount of recommended daily intake of the drink, for 4 weeks. On the other hand, the placebo group ingested the same amount of placebo drink for the same duration. Results Statistically significant decrease in body weight and BMI after 4 and 6 weeks of feeding in the test group were observed, but these were not thought to be no clinically concerning changes. Changes in the body fat percentage, waist size, vital sign, blood parameters and urine parameters were not observed during intake period. No adverse event attributed to the test drink was found in the study. Conclusions Thus, these results indicated the safety of the drink containing Japanese pagoda tree polyphenol in healthy adults include obesity persons in the case of excessive intake.（Jpn Pharmacol Ther 2008；36：931−9）KEY WORDS Japanese pagoda tree polyphenol （enzymatically modified isoquercitrin）, Safety, Excessive intake