The verification study of the anti-obesity effect in healthy Japanese adults: a double-blind randomized, parallel-group, controlled trial
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000022085
- Lead Sponsor
- ORTHOMEDICO, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Currently taking medicines (include herbal medicines), and/or supplements 4. Allergic to medicines or foods related to the test food of this trial 5. Pregnant, lactating, or planning to get pregnant during the trial period 6. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial 7. Judged unsuitable for participating in this trial by physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Total fat area 2. Subcutaneous fat area 3. Visceral fat area *Measuring point: at 0 week, 4 weeks, 8 weeks and 12 weeks after ingestion
- Secondary Outcome Measures
Name Time Method Weight Body Mass Index (BMI) Body fat percentage Waist Circumference Adiponectin Total cholesterol HDL cholesterol LDL cholesterol Triglyceride Free fatty acid Questionnaire (Likert scale) *Measuring point: at 0 week, 4 weeks, 8 weeks and 12 weeks after ingestion