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健常な成人男女を対象としたクロセチンの過剰摂取安全性試験―ランダム化二重盲検プラセボ対照並行群間比較試験―
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JPY
Abstract
Objective Crocetin, a kind of carotenoid, is a yellow pigment composition found in Gardenia fruits. The purpose of this study was to evaluate the safety of excessive intake of crocetin in healthy adult volunteers. Methods This study was a randomized, double-blind, placebo-controlled, parallel-group comparison trial. In total, 32 volunteers were randomly divided into two groups to consume either five crocetin(37.5 mg╱day)or five placebo capsules per day for four consecutive weeks. The safety of crocetin intake was evaluated by analyzing physical measurements, blood biochemistry, hematology, and urine. Results Safety evaluations of excessive intake of crocetin for four consecutive weeks revealed several significant differences; however, the changes were sporadic. Moreover, blood biochemistry analyses and hematological tests showed small changes that were within the normal range, and these were considered clinically insignificant and unrelated to treatments. Hence, no adverse changes related to crocetin intake in any volunteers were observed. Conclusion Excessive intake of crocetin (37.5 mg╱day)for four weeks was safe under the conditions of this study.
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