JPRN-UMIN000045361已完成Unknown
A study for evaluating the safety of the intake of a test food. - A study for evaluating the safety of the intake of a test food.
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 48
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) Those who regularly use foods (including foods for specified health uses) that contain a lot of dietary fiber materials (indigestible dextrin, polydextrose, indigestible glucan, etc.) (2) Those who regularly use medicines, health foods, foods for specified health uses, or functional foods that may affect bowel movements. (3) Those who are in the habit of consuming a large amount of foods that are thought to affect bowel movements (foods rich in dietary fiber and lactic acid bacteria) (4) Persons who are visiting a hospital and using medication for a bowel movement-related disease or who are regularly using over-the-counter laxatives at the time of research participation. (5) Those with a history or current condition of drug or alcohol dependence. (6) Persons with serious diseases such as diabetes, liver disease, renal disease, cardiac disease, or those with pre-existing diseases. (7) Persons at risk of developing allergies related to the research. (8) Those with a disease under treatment or with a history of serious disease that required medication. (9) Persons whose anthropometric, physical, and clinical values are significantly out of the reference range before the start of intake. (10) Those who have participated in other clinical research within one month prior to obtaining consent to participate in this study, or those who plan to participate in other clinical research after obtaining consent to participate in this. (11) Those who are pregnant or plan to become pregnant or breastfeed during the study period. (12) Those who are judged to be unsuitable as subjects based on the answers to the lifestyle questionnaire. (13) Any other person who is judged as inappropriate as a subject by the Chief Medical Officer.
研究者
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