JPRN-UMIN000044511已完成未知
Evaluation of changes in gut environment and biological barrier parameters by test-food intake - Evaluation of changes in gut environment and biological barrier parameters by test-food intake
CPCC Company Limited0 个研究点目标入组 30 人开始时间: 2021年6月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 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 40years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1)Subjects who have a plan or who have taken medication which would affect the trial result (e.g. drugs for anti-allergic, intestinal disorder, and laxative) after pre-inspection 1. (2)Subjects who have a plan or who have taken antibiotics within 3 months prior to the trial. (3)Subjects who are regularly consuming food for specified health uses (FOSHU), food with function claims, supplement and/or health foods which would affects the trial results for more than 3 days a week. (4)Subjects who have removed tonsils and/or appendix. (5)Subjects whose roomer is planning to join this trial. (6)Subjects who have received the surgery which would affect the trial result (e.g. colonoscopy, removal of gallstones and/or gall bladder, or gastric bypass surgery) within half a year before obtaining the consent. (7)Pregnant, possibly pregnant, or lactating women. (8)Subjects who have current medical history/anamnesis of severe cardiac, hepatic, renal or digestive diseases. (9)Subjects who take excessive alcohol. (10)Subjects who would encounter a dramatic change in their living environment (e.g. relocation, job-changing). (11)Subjects with irregular dietary habits or lifestyle (e.g. alternative work schedule, graveyard shift). (12)Subjects who are allergic to drugs or foods. (13)Subjects who are participating or have been participated to other clinical tests with specific medicine/food within the last 4 weeks before this trial, or planning to join those after giving informed consent. (14-16)Subjects who donated their blood components and/or whole blood prior to the pre-inspection as follows; - any subjects: 200 mL within a month - males: 400 mL within the last 3 months - females: 400 mL within the last 4 months. (17-18)Subjects whose collected blood volume within the last 12 months would reach to following criteria after adding the blood collection in this study; - males: 1,200 mL - females: 800 mL (19)Others who have been determined ineligible by principal/sub investigator.
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