A verification study of influence on defecation by consumption of the polydextrose-containing food for adult male and female with constipation tendency
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000025944
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 90
Not provided
(1)Subjects who are diagnosed as a strong constipation by a doctor. (2)Subjects who are diagnosed with diabetes (including boundary type) by a doctor. (3)Subjects who regularly use medical drugs and/or supplements that have bowel movement improving effect. (4)Pregnant or expected pregnant women, or lactating women. (5)Subjects who have previous and/or current medical history of serious disease in heart, liver, kidney and/or digestive trucks. (6)Subjects who excessive alcohol intake. (7)Subjects who have extremely irregular life rhythm, and subjects who have midnight work or irregular shift work. (8)Subjects who have previous medical history of drug and/or food allergy. (9)Subjects who are participating the other clinical tests of medicines or foods. Subjects who participated other clinical tests of medicines or foods within 4-weeks prior to the current study. Subjects who are planning to participate in other clinical tests of medicines or foods after agreeing with participating in this study. (10)Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (11)Males who donated over 400mL blood within the last three month to the current study. (12) Females who donated over 400mL blood within the last four month to the current study. (13) Males who will be collected over 1200mL blood, 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, when the sampling amounts within the last twelve month 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 umber of defecation (days of defecation)
- Secondary Outcome Measures
Name Time Method *Feces property (amount, shape, color, smell, sensation after defecation) *Intestinal microflora *Physicochemical analysis of feces ( fecal organic acid, fecal decay products)