JPRN-UMIN000044543已完成未知
Safety Evaluation for Excessive Ingestion of Coffee-Derived Chlorogenic Acids: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study - Safety Evaluation for Excessive Ingestion of Coffee-Derived Chlorogenic Acids
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 65years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Subjects who are under physician's advice, treatment and/or medication for dyslipidemia and/or diabetes. 2. Subjects with familial hypercholesterolemia. 3. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal disease, and/or affected with infectious diseases requiring reports to the authorities. 4. Subjects with major surgical history relevant to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 5. Subjects with unusually high and/or low blood pressure, abnormal physical data and/or abnormal hematological data. 6. Subjects with severe anemia. 7. Pre- or post-menopausal women complaining of obvious physical changes. 8. Subjects who are at risk of having allergic reactions to drugs, foods especially based on coffee, milk, egg, wheat, shrimp, soybean, chicken, and/or pork. 9. Subjects with lactose intolerance. 10. Subjects who regularly take medicines, functional foods, and/or supplements which would affect lipid metabolism. 11. Subjects who regularly take medicines, functional foods and/or supplements which would affect glucose metabolism. 12. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 13. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks, or blood components within 2 weeks, prior to the current study. 14. Pregnant or lactating women or women who expect to be pregnant during this study. 15. Subjects who currently participate in other clinical trials, or participate within the last 4 weeks prior to the study. 16. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
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