A verification study of the dose dependence with the test food on healthy and overweight humans: a randomized, double-blind, placebo-controlled, parallel-group trial
- Conditions
- Healthy and overweight Japanese adult subjects between 23 kg/m2 or more and less than 30 kg/m2 in body mass index (BMI)
- Registration Number
- JPRN-UMIN000035208
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
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 excessive exercise 5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 6. Subjects who are currently taking medications (including herbal medicines) and supplements 7. Subjects who are an allergic reaction to medications and/or products that contain the study ingredients 8. Subjects who are pregnant, lactation, or planning to become pregnant 9. 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 10. 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 in a cross section of the umbilical region * Assess the fat area by X-ray CT * Calculate the amount of change between screening (before consumption) and 12 weeks after consumption
- Secondary Outcome Measures
Name Time Method 1. Total fat area 2. Subcutaneous fat area 3. Visceral fat area 4. Body weight 5. Body mass index 6. Body fat percentage 7. Lean body mass 8. Body water 9. Muscle mass 10. Abdominal circumference 11. Basal metabolic rate 12. Waist circumference 13. Hip circumference 14. Abdominal obesity ratio 15. Subjective symptoms (the Likert scale) *1-3 Assess these by X-ray CT of the umbilical region *1, 2 Compare the measured values at screening (before consumption) and at 12 weeks after consumption and calculate the amount of change *3 Compare the measured values between screening (before consumption) and 12 weeks after consumption *4-15 Compare the measured values at screening (before consumption) and at 4, 8, and 12 weeks after consumption and calculate the amount of change