Healthy male/female adults
Conditions
Interventions
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy male/female subjects ranging in age from 20 to 64, at informed consent. (2) Subjects who can take one meal of the test food per day. (3) Subjects who can receive the test foods once a week (4) Subjects who defecate three to five times a week. (5) Subjects who can give informed consent, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: Subjects- (1) regularly taking affecting (intestinal regulation) food for specified health use, functional foods, health foods (including supplements), yogurt, or lactic acid bacteria beverages not less than 3 times a week. (2) taking or will take in affecting medicines (antibiotic/gut/laxative regulation) within the last month before the advance inspection and during this study. (3) planning to vaccinate from advance inspection to the end of this study. (4) with history of appendix removal. (5) who have received the affecting surgery (e.g. colonoscopy, removal of gallstones an d/or gall bladder, or gastric bypass surgery) within half a year before the consent. (6) with excessive alcohol intake. (7) with extremely irregular dietary habits. (8) restricting their mealtimes to no more than once a day (not less than once a week), within the last month. (9) planning to change their life style, dietary habit and Living environment (relocation, transfer). (10) being under other clinical test of medicine and/or health food, or join within the last 4 weeks, or will join after the consent. (11) whose housemate is planning to join this study. (12) with previous/current medical history of serious diseases (severe cardiac, hepatic, renal or digestive diseases, etc). (13) with pregnancy, possibly one, or lactating. (14) with drug/food (especially wheat, eggs, or milk) allergy. (15) who donated their blood components or blood (0.2 L) within the last month. (16) who donated his blood (0.4 L) within the last 3 months. (17) who donated her blood (0.4 L) within the last 4 months. (18) being collected in total of his blood (1.2 L) within the last 12 months and in this study. (19) being collected in total of her blood (0.8 L) within the last 12 months and in this study. (20) being determined as ineligible for participation, judging from the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intestinal flora (next generation-targeted amplicon sequencing analysis) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 and water 3. In saliva: cortisol, cortisol corrected by protein, alpha-amylase, and alpha-amylase corrected by protein 4. In blood: miRNA 5. Constipation assessment scale-mid term 6. Visual Analog Scale (stress, fatigue, the feeling at waking up this morning, concentration) 7. Clinical test value | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed