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モノグルコシルルチン配合緑茶の12 週間継続摂取による脂質代謝に対する有効性および安全性の評価―プラセボ対照ランダム化二重盲検並行群間比較試験―
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JPY
Abstract
Objectives We evaluated the effects and safety of green tea containing mono-glucosylrutin on lipid metabolism in this randomized, double-blind, placebo-controlled, parallel-group comparison study. Methods One hundred healthy Japanese people with a low-density lipoprotein cholesterol (LDL-C)level≥120 mg╱dL and<160 mg╱dL were randomly divided into test and placebo groups. Subjects drank test green tea(containing 65 mg mono-glucosylrutin)or placebo green tea(not containing mono-glucosylrutin)daily for 12 weeks. Physical, blood, and urinary examinations and medical interviews were conducted at weeks 0, 4, 8, and 12, and at 4 weeks after the end of the trial period. Results LDL-C did not significantly differ between the groups. However, there were differences over time for apolipoprotein(Apo)AI and the Apo B╱Apo AI ratio, and Apo AI, the Apo B╱Apo AI ratio, and the LDL-C╱high-density lipoprotein cholesterol(HDL-C)ratio improved with intake of test green tea at 4 weeks after the end of the trial. Bodyweight significantly decreased in the test group at weeks 4, 8, and 12. No abnormal changes or severe adverse events were observed with physical, blood, and urinary examinations nor reported during medical interviews during the trial. Conclusions Green tea containing mono-glucosylrutin was safe over the long term and improved apolipoprotein in lipid metabolism, the LDL-C╱HDL-C ratio, and bodyweight. (UMIN-CTR ID:000021452)
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