Healthy male/female adults
Conditions
Interventions
Consumption of the test food-1 twice a day for 12 weeks.
Consumption of the test food-2 twice a day for 12 weeks.
Consumption of the placebo food twice a day for 12 weeks.
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 ranging in BMI from not less than 23.0 to less than 30.0 kg/m2. (3) Subjects who can take the test foods for meals twice a day. (4) Subjects who can receive the test foods twice 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) with dieting (exercise, meal-control), or going on, (2) taking in affecting foods (obesity/gut/ immuno-regulation, not less than 3 times a week, (3) with excessive alcohol intake, (4) who have taken affecting medicines (allergic/gut/laxative/obesity/antibiotic regulation) within the last month before the test-food intakes, (5) with history of appendix removal, (6) who have received affecting surgeries (colonoscopy, gallstones/gall bladder removal, gastric bypass) within half a year before the consent, (7) planning to change their present life style and dietary habit, (8) with extremely irregular dietary habit, (9) with the roomer planning to participate in this study, (10) restricting their mealtimes to no more than once a day (not less than once a week), within the last month, (11) with medical history of serious diseases, (12) with a continuous medical treatment, (13) with not less than 6.5 % HbA1c, (14) with not less than 126 mg/dL of hungry blood-sugar level, (15) with not less than 25.0 kg/m2 of BMI and not less than 100 cm2 of abdominal fat area, (16) with pregnancy, possibly one, or lactating, (17) with drug/food allergy (wheat, egg, milk), (18) being under the other clinical tests (medicine or health food), or took part in those within the last 4 weeks, or will join those after the consent, (19) who donated their blood components or blood (0.2 L) within the last month, (20) who donated his blood (0.4 L) within the last 3 months, (21) who donated her blood (0.4 L) within the last 4 months, (22) being collected in total of his blood (1.2 L) within the last 12 months and in this study, (23) being collected in total of her blood (0.8 L) within the last 12 months and in this study, (24) being determined as ineligible by the principal/sub investigator - - .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visceral fat area (impedance method) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Abdominal total fat area (impedance method) 2. Abdominal subcutaneous fat area (impedance method) 3. Abdominal circumference 4. Body weight 5. Body-mass index 6. Body fat percentage (impedance method) 7. Body fat quantity (impedance method) 8. Blood pressure 9. Adiponectin 10. Gut microbiota (amplicon sequencing analysis) 11. Short chain fatty acids and IgA in feces 12. Total cholesterol, low density lipoprotein-cholesterol, high density lipoprotein-cholesterol, glucose | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed