薬理と治療

Abstract

Objectives　The purpose of this study was to evaluate the safety of six folds intake of the specified kiwifruit extract continuously for twelve weeks in healthy adult humans. Methods　We conducted a randomized double-blind placebo-controlled parallel-group study with healthy adult Japanese subjects allocated to either a specified kiwifruit extract group（47.4 ±7.9 years old, n＝12）or a placebo group （45.5±8.2 years old, n＝12）. The participants took 1800 mg/day of a specified kiwifruit extract or a placebo capsule for twelve weeks. Safety was evaluated using hematologic test, blood biochemical test, urine analysis, physical examination. Results　Statistically significant differences observed in some test parameters were considered clinically insignificant. There were no adverse events associated with six folds intake of a specified kiwifruit extract for twelve weeks. Conclusions　Our results suggest that there was no safety problem daily intake of the specified kiwifruit extract continuously. UMIN-CTR ID: UMIN000032657