JPRN-UMIN000028319已完成未知
Safety Evaluation for Excessive Ingestion of Food Containing Pinitol - Safety of Excessive Ingestion of Food Containing Pinitol
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 64
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 diabetes. 2. Subjects whose HbA1c is >=6.5% 3. Subjects whose FBG is >=126 mg/dl. 4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 5. Subjects with major surgical history relevant to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 6. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 7. Subjects with severe anemia. 8. Pre- or post-menopausal women complaining obvious physical changes. 9. Subjects who are at risk of having allergic reactions to drugs or foods based on especially leguminous plants including soybeans, and ice plants, yeasts, gelatin and milk. 10. Subjects who regularly take medicine, functional foods and/or supplements (containing dietary fiber such as indigestible dextrin, polyphenol, etc.) which would affect glucose metabolism. 11. Heavy smokers, alcohol addicts or subjects with the eating disordered lifestyle. 12. 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. 13. Pregnant or lactating women or women expect to be pregnant during this study. 14. Subjects who currently participate in other clinical trials or participated within the last 4 weeks prior to the current study. 15. Any other medical and/ or health reasons unfavorable to participation into the current study judged by the principal investigator.
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