JPRN-UMIN000047853已完成未知
Effect of Daily Ingestion of the Bifidobacterium and Dietary Fiber on Improving Vascular Endothelial Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study - Beneficial Effect of the Bifidobacterium and Dietary Fiber on Improving Vascular Endothelial Function.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 60
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
- 40years-old 至 65years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Subjects with difficulty measuring flow- mediated dilation. 2. Subjects who are under physician's advice, treatment, and/or medication for hypertension, dyslipidemia and/or diabetes. 3. Subjects who have a history of bronchial disease (ex. asthma, tuberculosis, pleurisy). 4. Subjects with implantable electronic medical devices. 5. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 6. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 7. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 8. Subjects with severe anemia. 9. Pre- or post-menopausal women complaining of obvious physical changes. 10. Subjects who are at risk of having allergic reactions to drugs or foods especially based on milk. 11. Subjects who used antibiotics within 12 wks, prior to this study. 12. Subjects who regularly use gastrointestinal drugs. 13. Subjects who cannot abstain from taking yoghurt, lactic acid bacteria drink, functional foods which would affect bowl movement during this study. 14. Smokers, alcohol addicts or subjects with disordered lifestyle. 15. Subjects who donated either 400 ml whole blood within 16 wks (women), 12 wks (men), 200 ml whole blood within 4 wks, or blood components within 2 wks, prior to this study. 16. Pregnant or lactating women or women who expect to be pregnant during this study. 17. Subjects who currently participate in other clinical trials, or participated within the last 4 wks prior to this study. 18. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
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