A Study of the effects of a test-food on gut microenvironment
- Conditions
- Healthy male/female adults
- Registration Number
- JPRN-UMIN000045648
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 16
Not provided
(1) Subjects who take steadily (not less than three times a week) in the health-specific/functional/supplementary/health foods, yogurts or lactic acid beverages, which might affect the test results (intestinal regulation and immune maintenance). (2) Subjects who have taken affecting medicines (allergic/gut/laxative/antibiotic regulation) except eye/nose drops, within the last month before the hospital visiting (0 W at the first stage). (3) Subjects who will vaccinate within the last three weeks before the hospital visiting (0 W at the first stage) and during this study. (4) Subjects who had undergone appendectomy. (5) Subjects who have received the affecting surgery (e.g. colonoscopy, removal of gallstones and/or gall bladder, or gastric bypass surgery) within half a year before obtaining the consent. (6) Subjects who will change their life style and dietary habit during this study. (7) Subjects with extremely irregular dietary habits. (8) Subjects who take excessive alcohol. (9) Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases. (10) Pregnant, possibly pregnant, or lactating women. (11) Subjects having drug and/or food allergy. (12) Subjects who are now under another clinical test with some kind of medicine and/or health food, or took part in that within four weeks before this study, or will participate in that after giving informed consent to take part in this study. Subjects - - (13) who donated their blood components or blood (0.2 L) within the last month, (14) who donated his blood (0.4 L) within the last 3 months, (15) who donated her blood (0.4 L) within the last 4 months, (16) being collected in total of his blood (1.2 L) within the last 12 months and in this study, (17) being collected in total of her blood (0.8 L) within the last 12 months and in this study - - . (18) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intestinal flora (next generation-targeted amplicon sequencing analysis)
- Secondary Outcome Measures
Name Time Method 1. Defecation status (the number of days, frequency, quantity, property, color, fecal odor, feeling of incomplete evacuation, abdominal pain) 2. In stool: short chain fatty acids, ammonia, spoiled products, pH, water, and IgA 3. In blood: NK-cell activity, highly sensitive CRP, IL-6, and TNF-alpha 4. In saliva: cortisol and alpha-amylase 5. Constipation assessment scale-mid term 6. MOS 36-Item Short-Form Health Survey version2 (acute version)