JPRN-UMIN000041199已完成未知
Confirmation study about effects on intestinal microbiota and safety of dietary fiber mixture powder intake in healthy subjects - Effects of dietary fiber mixture powder on intestinal microbiota
CPCC Company Limited0 个研究点目标入组 60 人开始时间: 2021年7月26日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 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
- 20years-old 至 64years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1) Subjects who take some kind of prescribed medication, including nasal/eye drops or ointments, on the day of informed consent. (2) Subjects who have regularly used and can not stop using the following products that may affect study results from the day of informed consent until the last visit; general drugs, quasi drugs, Food for Specified Health Uses, Foods with Function Claims, health foods, dietary fiber-rich products, etc. (3) Excessive alcohol intake (more than 60 g/day as pure alcohol on average). (4) Vegetarians. (5) Subjects with extremely irregular frequency or timing of meals, and/or midnight work or irregular shift work. (6) Subjects who are under the other clinical study related to medicine/food, have taken part in those studies within four weeks or be planning to participate in after informed consent. (7) Currently pregnant, intended to become pregnant or nursing an infant. (8) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (9) Subjects with previous medical history of drug and/or food allergy. (10) Subjects with weak stomach and/or diarrhea-prone constitution. (11) Subjects who donated their blood (200 mL) and/or blood components within the last one month to this study. (12) Males who donated their blood (400 mL) within the last three months to this study. (13) Females who donated their blood (400 mL) within the last four months to this study. (14) Males who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this study. (15) Females who will be collected in total of their blood (800 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this study. (16) Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinions.
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