Male/female adults
Conditions
Interventions
Consumption of the test food (10 capsules a day) with water/lukewarm water to the subjects for four weeks.
Consumption of the placebo food (10 capsules a day) with water/lukewarm water to the subjects
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Male/female subjects ranging in age from 20 to 64, at informed consent. 2 Subjects ranging in defection frequency from not less than three times to no more than five times a week. 3 Subjects who can give informed consent to participate in this research, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: Subjects 1 who take steadily (not less than 3 times a week) in the health-specific/ functional/supplementary/health foods, yogurts or lactic acid bacteria beverages, which might affect the test results (intestinal regulation and immune maintenance). 2 who have taken affecting medicines (e.g., allergic/antibiotic/gut/laxative regulation) except eye/nose drops, within the last month before the hospital visiting (0 W at the first stage). 3 who will vaccinate within after the time point of pre-test, and before the hospital visiting (4 W at the second stage) during this research. 4 who had undergone appendectomy. 5 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 who take excessive alcohol. 7 with extremely irregular dietary habits. 8 who will change their life style, dietary habit, and living environment (e.g., move, transfer) during this research. 9 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 research, or will participate in that after giving informed consent to take part in this research. 10 whose roomer is planning to partake in this research. 11 who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases. 12 pregnant, possibly pregnant, or lactating women. 13 having drug and/or food allergy. 14 who donated their blood components or blood (0.2 L) within the last month, 15 who donated his blood (0.4 L) within the last 3 months, 16 who donated her blood (0.4 L) within the last 4 months, 17 being collected in total of his blood (1.2 L) within the last 12 months and in this research, 18 being collected in total of her blood (0.8 L) within the last 12 months and in this research 19 who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
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. Physicochemical tests in feces (short chain fatty acids, ammonia, spoiled products, pH, water, and IgA) 3. Immunological tests in blood (NK-cell activity) 4. Constipation assessment scale-mid term 5. Clinical examination values | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed