Validation study on body fat-reducing effects by a long-term test-drink ingestio
- Conditions
- Healthy male/female adults
- Registration Number
- JPRN-UMIN000049522
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visceral fat area (X-ray computerized tomography)
- Secondary Outcome Measures
Name Time Method 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.)