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薬理と治療
Abstract
Objective A randomized double-blind placebo-controlled study for 12 weeks was conducted on 46 subjects to evaluate the safety of the food containing olive and grape seed polyphenols in the case of long︱term intake in healthy adults. Methods The subjects(23 males and 23 females; mean age, 39.9±9.3 years old)were randomly divided into two groups, one is test group and the other is placebo group. The test group ingested daily 4 capsules of test food including 50 mg of olive extract containing 6 mg of hydroxytyrosol and 75 mg of grape seed oligomeric proanthocyanidins for 12 weeks. On the other hand, the placebo group ingested the same amount of placebo food for the same duration. The incidence and severity of side effects or adverse events were monitored during the study period. Results No adverse event attributed to the test food was found in the study. The incidence of adverse events were 29.2% or 20.8% in the placebo or test food group respectively, which was no statistically significant difference. No clinically significant changes in the vital signs, blood parameters and urine parameters were observed during the study period. Conclusions Thus, these results indicated the safety of the food containing olive and grape seed polyphenols in the case of long-term intake.
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