Effects of consumption of the test food on the visceral fat
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000045007
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 44
Not provided
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," "Foods with Function Claims," or other functional food/beverage in daily use 5. Subjects who are currently taking medications (including herbal medicines) and supplements (especially antidiabetic agent, antihypertensive, and immunosuppressant) 6. Subjects who are allergic to medications and/or the test-food-related products 7. Subjects who are pregnant, lactation, or planning to become pregnant 8. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 9. Subjects who are judged as ineligible to participate in the study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The measured values of abdominal visceral fat area at 12 weeks after consumption (12w)
- Secondary Outcome Measures
Name Time Method 1. The measured values of abdominal visceral fat area at six weeks after consumption (6w) 2. The amount of change of abdominal visceral fat area between screening (before consumption; Scr) and 6w or 12w 3. The measured values and amount of change from Scr in each of the following items at 6w and 12w: abdominal subcutaneous fat area, total abdominal fat area, Chalder Fatigue (CF) score, body weight, body mass index (BMI), abdominal circumference, waist circumference, body fat percentage, fat mass, lean body mass, muscle mass, lactic acid, pyruvic acid, and lactate-to-pyruvate ratio 4. The measured values and amount of change from Scr of growth and differentiation factor 15 (GDF15) at 6w and 12w 5. The each question items of Chalder Fatigue Scale (CFS) at 6w and 12w