JPRN-UMIN000030323已完成未知
Safety Evaluation for Excessive Ingestion of Nanoparticulated Brown Rice Germ Extract. - Safety of Excessive Ingestion of Nanoparticulated Brown Rice Germ Extract.
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 obese, hyperlipidemia and diabetes. 2.Subjects with familial hypercholesterolemia. 3.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, 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 and/or abnormal hematological data. 6.Subjects with severe anemia. 7.Pre- or post-menopausal women complaining obvious physical changes. 8.Subjects who are at risk of having allergic reactions to drugs or foods, especially gramineae. 9.Subjects who regularly take medicine, functional foods, and/or supplements which would affect BW and BFP. 10.Subjects who regularly take medicine, functional foods, and/or supplements which would affect blood lipid levels. 11.Subjects who regularly take medicine, functional foods and/or supplements which would affect glucose metabolism. 12.Heavy smokers, alcohol addicts or subjects with the eating disordered lifestyle. 13.Subjects who donated either 400ml whole blood within 16 weeks (women) /12 weeks (men) or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to the current study. 14.Pregnant or lactating women or women expect to be pregnant during this study. 15.Subjects who currently participate in other clinical trials or participated within the last 4 weeks prior to the current study. 16.Any other medical and/ or health reasons unfavorable to participation into the current study judged by the principal investigator.
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