A verification study of anti-obesity effects of the test food
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000036765
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 11
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 receive hormonal therapy 5. Subjects who are planning to undergo a surgical operation within two weeks from the date of finish of the intervention period 6. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 7. Subjects who have habits of excessive exercise 8. Subjects who are currently taking medications (including herbal medicines) and supplements. Particularly taking an antidiabetic drug in daily. 9. Subjects who are allergic to medicines and/or the test food related products 10. Subjects who are pregnant, lactation, or planning to become pregnant 11. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period 12. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The visceral fat area * Assess these by X-ray CT in a cross section of the umbilical region. * Assess the measured value at screening (before consumption) and at 8 weeks after consumption or calculate the amount of change.
- Secondary Outcome Measures
Name Time Method 1. Total fat area 2. Subcutaneous fat area 3. Blood adiponectin level 4. Blood triglyceride level 5. Body weight 6. Body mass index 7. Body fat percentage 8. Abdominal circumference 9. Subjective symptoms (the Likert scale) *1, 2 Assess these by X-ray CT in a cross section of the umbilical region. *1-9 Assess the measured value at screening (before consumption) and at 4 and 8 weeks after consumption or calculate the amount of change.