Healthy male/female adults
Conditions
Interventions
Ingestion of the test food to the subjects, two a day (at breakfast, lunch or dinner) for 12 weeks.
Ingestion of the placebo food to the subjects, two a day (at breakfast, lunch or dinner) for 12 week
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 who can take the test food two a day. (3) Subjects who can receive the test foods twice a week. (4) Subjects with defection frequency of no more than five times a week. (5) Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: Subjects - - (1) taking in affecting foods (e.g., L. lactis strain Plasma) over 3 times a week, (2) who have taken affecting medicines (e.g., antibiotic), within the last month before a pre-test, (3) who take affecting medicine (e.g., anti-histamine, multi-ingredient cold medication) over twice a week, (4) taking in a yogurt, probiotic beverage, dietary fiber-rich staple food (e.g., unpolished rice) over 3 times a week, (5) who had undergone appendectomy, (6) who have received the affecting surgery (e.g., colonoscopy) within half a year before the consent, (7) who will vaccinate within the last month before and during this study, (8) taking excessive alcohol, (9) with extremely irregular life rhythms (e.g., midnight work), (10) taking oral medication or medical diet, (11) being under a low-carb diet, (12) having below a meal a day (over a day a week), within the last month before a pre-test, (13) who will change their life style, dietary habit, and living environment (e.g., move) during this study, (14) being under another clinical test with a medicine or health food, or partook in that within 4 weeks before this study, or will partake in that after the consent, (15) with over 30.0 kg/m2 of BMI, (16) whose roomer is planning to partake in this study, (17) with previous/current medical history of severe cardiac, hepatic, renal or digestive diseases, (18) with pregnancy, possibly one, or lactating, (19) having drug and food allergy (wheat, egg, milk and soybean), (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 last 3 months, (22) who donated her blood (0.4 L) within the last 4 months, (23) being collected in total of his blood (1.2 L) within the last 12 months and in this study, (24) being collected in total of her blood (0.8 L) within the last 12 months and in this study, (25) who have been determined as ineligible for participation, by the principal/sub doctor - - .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total amount of short chain fatty acids in feces (total amount of acetic acid, propionic acid, and n-butyric acid) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Short chain fatty acids in feces (acetic acid, propionic acid, and n-butyric acid) 2. Intestinal flora 3. Organic acid in feces (lactic acid, succinic acid, iso-valeric acid, n-valeric acid, formic acid, iso-butyric acid) 4. Immunoglobulin-A in feces 5. Ammonia in feces 6. Spoiled products in feces 7. Water in feces 8. pH in feces 9. Activity of plasmacytoid dendritic cells (cluster of differentiation 123, blood-dendritic cell antigen 4, cluster of differentiation 86, human leukocyte antigen DR, cluster of differentiation 40, cluster of differentiation 80) in blood 10. Constipation assessment scale-mid term 11. Defecation status (the number of days, frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, fecal odor) | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed