Healthy male/female adults
Conditions
Interventions
Consumption of the test drink (2 bottles, 200 mL) after breakfast, once a day.
Consumption of the placebo drink (2 bottles, 200 mL) after breakfast, once a day.
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 give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: (1) Subjects being under the restriction of meal with dieting (losing some weight by exercises and meal-controlling), and/or are planning to go on a diet. (2) Subjects taking steadily (over 3 times a week) in the following affecting foods (related to anti-obesity and lipid metabolism); health-specific, functional, supplementary, health foods, vitamin tablet and nutrient. (3) Subjects who have any difficulty in refraining from taking steadily in affecting medicines (e.g., anti-obesity and lipid metabolism). (4) Subjects who have taken affecting medicines (antibiotics) within the last month before the test-drink intakes, and planning to take those medicines. (5) Subjects with not less than 25.0 kg/m2 of BMI and not less than 100 cm2 of abdominal fat area, at the screening test. (6) Subjects with excessive alcohol intake. (7) Subjects with current and/or previous medical history of serious diseases in heart, liver, kidney and/or digestive organs. (8) Pregnant, lactating women, and possibly pregnant ones. (9) Subjects with drug and/or food allergy. (10) Subjects being under other clinical tests with some kind of medicine/food, or partook in those within four weeks before this study, or planning to join those after the consent. (11) Subjects who donated over 0.2 L of their blood and/or blood components within a month to this study. (12) Males who donated their whole blood (0.4 L) within the last three months to this study. (13) Females who donated their whole blood (0.4 L) within the last four months to this study. (14) Males who will be collected in total of their blood (1.2 L) within the last twelve months, after adding the blood amounts planning to be sampled in this study. (15) Females who will be collected in total of their blood (0.8 L) within the last twelve months, after adding the blood amounts planning to be sampled in this study. (16) Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visceral fat area (X-ray computerized tomography) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Abdominal total fat area (X-ray computerized tomography) 2. Abdominal subcutaneous fat area (X-ray computerized tomography) 3. Abdominal circumference 4. Body weight, and body-mass index 5. Body fat percentage (impedance method), and body fat quantity (impedance method) 6. Blood pressure, and heart rate 7. Blood-adipocytokine test (adiponectin) 8. Gut microbiota (amplicon sequencing analysis) 9. The Profile of Mood States Second Edition (Japanese short ver.) | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed