JPRN-UMIN000041187已完成未知
Effect of Daily Ingestion of the Dietary Fiber made from Rice Bran on Bowel Movements and Improving Minor Ailments: An Open-Label, Uncontrolled Pilot Study - Effect of Daily Ingestion of the Dietary Fiber made from Rice Bran on Bowel Movements and Improving Minor Ailments
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
- 30years-old 至 65years-old（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •1.Subjects with a clinical history of gastrointestinal cancer or currently under treatment or anti-tumor medication. 2.Subjects with gastrointestinal disorders such as inflammatory bowel syndrome, irritable bowel syndrome, etc. 3.Subjects who have used as needed or continued to use antibiotics within 3 months prior to screening test. 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 the 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 of obvious physical changes. 9.Subjects who are at risk of having allergic reactions to drugs or cedar pollen or foods especially based on soybean, pork, gelatin, egg, wheat, milk and apple. 10.Subjects who regularly take drugs, functional foods and/or supplements which potentially affect bowel movements. 11.Subjects who cannot abstain from taking any of health-oriented foods during the study period. 12.Subjects who cannot abstain from taking too much of oligosaccharide, dietary fiber, yoghurt, lactic acid bacteria beverage, natto during the study period. 13.Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 14.Subjects who donated either 400 ml whole blood within 16 weeks or 200 ml whole blood within 4 weeks or blood components within 2 weeks prior to the screening tests. 15.Pregnant or lactating women or women expect to be pregnant during this study. 16.Subjects who currently participate in other clinical trials or participated within the last 4 weeks prior to the current study. 17.Any other medical and/ or health reasons unfavorable to participation into the current study judged by the principal investigator.
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