A confirmation test of Intestine regulating effects by ingesting test foods
- Conditions
- ot applicable
- Registration Number
- JPRN-UMIN000039471
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 56
Not provided
(1) Subjects who are given continuous treatment by taking medicines. (2) Subjects who use medicines, food for specified health use, functional foods, health foods and supplements more than 3 days a week, those possibly have improving effect of defecation and/or loose stool. (3) Subjects who eat food products containing relatively large amount of yogurt, lactic bacteria beverages and dietary fiber more than 3 days a week. (4) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. (5) Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ) containing history of surgical operations. (6) Subjects who excessive alcohol intake. (7) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. (8) Subjects who have previous medical history of drug and/or food allergy (especially to milk and/or to shellfish). (9) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. (10) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (11) Subjects who donated over 400mL blood and/or blood components within the last three months to the current study. (12) Females who donated over 400mL blood and/or blood components within the last four months to the current study. (13) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (14) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve months are adding to the planned sampling amounts of this study. (15) Others who have been determined ineligible by principal investigator or sub-investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method * Defecation situation (number of defecation, days of defecation, Bristol Stool Scale score) * Intestinal microbiota (T-RFLP method)
- Secondary Outcome Measures
Name Time Method * Defecation situations (odor of stool, color of stool, exhilaration of defecation, abdominal symptoms) * GSRS questionnaire * Fecal organic acids * Fecal ammonia * Fecal decay products * Fecal properties (pH, water contents)