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オリーブおよびブドウ種子ポリフェノール含有食品の健常者に対する過剰摂取時の安全性―ランダム化プラセボ対照二重盲検並行群間比較試験―
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JPY
Abstract
Objective The aim of this study was to evaluate the safety of excessive intake of the food containing olive and grape seed polyphenols in healthy adults. Methods Forty-eight healthy adults(24 males and 24 females; mean age, 46.7±13.2 years) were enrolled in a randomized double-blind placebo-controlled study. Subjects were randomly assigned to the test food group(250 mg of olive extract containing 30 mg of hydroxytyrosol, 375 mg of grape seed oligomeric proanthocyanidins)or the placebo group and ingested daily for 4 weeks. The incidence and severity of side effects or adverse events were monitored during the study period. Results No side effect was observed in both groups. Adverse events were observed in 8.7% of the subjects in the test food group and 29.2% in the placebo group. No clinically significant changes were observed in laboratory testing(blood biochemistry, hematology, and urinalysis) as well as in physical measurements in both groups throughout the intervention. Conclusions Daily ingestion of excessive amounts of the food rich in olive and grape seed polyphenols for 4 weeks was safe in humans.
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