Validation study of the effects on gut microenvironment by test-beverage intakes
- Conditions
- Healthy male/female adults
- Registration Number
- JPRN-UMIN000050001
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 120
Not provided
Subjects - - (1) who take in affecting health-specific/functional/supplementary/health foods, lactic acid drinks (including yogurt drinks), or bifidobacterial beverages, over twice a week, (2) who take in yogurt, over 3 times a week, (3) who take in oligosaccharide and dietary fiber, over twice a week, (4) not having a habit of drinking milk, over once a week, (5) who have taken affecting medicines (gut/digestive/constipation/laxative regulation), over once a week, (6) having loose stools, owing to milk or cold beverage ingestion, (7) having a tendency to repeat constipation and diarrhea, (8) having a tendency to increase a defecation frequency by continuous intakes of water (0.1 L), (9) having constipation and diarrhea, owing to a menstruation, (10) with over 30.0 kg/m2 of BMI, (11) with frequency in going out, below twice a week, (12) with heavy smoking and excessive alcohol, (13) who have been on antibiotics after the pre-test to the hospital visiting (0 W), (14) planning to go on a long or trip abroad after the pre-test and during this study, (15) with extremely irregular eating habits / life rhythm, (16) having medical history of severe cardiac, hepatic, renal or digestive diseases, (17) with pregnancy, possibly one, or lactating, (18) having drug and food allergy (especially to milk and soybean), (19) being under another clinical test with medicine or health food, or partook in that within the past 4 weeks, or will partake in that after the consent, (20) who donated their blood components or blood (0.2 L) within the last month, (21) who donated his blood (0.4 L) within the past 3 months, (22) who donated her blood (0.4 L) within the past 4 months, (23) being collected in total of his blood (1.2 L) within the past 12 months and in this study, (24) being collected in total of her blood (0.8 L) within the past 12 months and in this study, (25) determined as ineligible for participation, judging from the principal/sub investigator - - .
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intestinal flora
- Secondary Outcome Measures
Name Time Method 1. Physical and chemical analysis of stool and urine samples 2. Questionnaire about defecation status and health-related Quality of Life