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ウィンターセイボリーエキスの長期摂取時および過剰摂取時における安全性の検証―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
Objectives To evaluate the safety of long-term intake or excessive intake of the winter savory extract. Methods Randomized double-blind placebo-controlled parallel-group studies were conducted in 40 healthy volunteers(20 males, 20 females)to evaluate the safety of long-term intake. Volunteers were randomly assigned to two groups and given 1 bottle(100 mL)╱day of the test food that either did or did not contain the winter savory extract(0.54 g╱bottle)for 12 weeks. In the excessive intake trial, 36 healthy volunteers(18 males, 18 females)were given 3 bottles of each daily for 4 weeks. Results No adverse event attributed to the test food was found in both studies and No clinically significant changes in the vital signs, body weight, BMI, blood pressure, blood parameters and urine parameters were observed during the study period. Conclusion These results indicated that the winter savory extract was safe for long-term and excessive intake. Trial registration UMIN000028316;UMIN000028315
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