Effects of consumption of the test food on waist circumference (abdominal circumference) in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
- Conditions
- Healthy Japanese
- Registration Number
- JPRN-UMIN000052666
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 100
Not provided
Individuals (who/whose) 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. take herb or foods with hypoglycemic effects 6. are taking medications (including herbal medicines) and supplements 7. are allergic to medicines and/or the test food related products 8. notice a weak stomach and may feel discomfort such as convergence in the stomach, particularly when taking beverages containing tannin such as green tea, black tea, or coffee 9. have irregular lifestyles (such as diet, exercise, and sleep) 10. weekly average of pure alcohol intake is more than 60 g/day 11. are pregnant, lactating, or planning to become pregnant during this trial 12. 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 13. have donated blood component or 200 mL whole blood within the last one month before the agreement to participate in this trial 14. have donated 400 mL whole blood within the last three month before the agreement to participate in this trial 15. are scheduling to have a total of more than 1,200 mL of blood drawn until the end of this study from the 12 months before the date of consent obtained 16. are judged as ineligible to participate in this study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The measured value of waist circumference at 12 weeks after consumption (12w)
- Secondary Outcome Measures
Name Time Method 1. The measured value of waist circumference at eight weeks after consumption (8w) 2. The amount and rate of changes of waist circumference between screening (before consumption; Scr) and 8w, or 12w 3. The measured values of body weight, body mass index (BMI), body fat percentage, hip circumference, thigh circumference, lean body mass, muscle mass, fat mass, total cholesterol (T-Cho), high density lipoprotein-cholesterol (HDL-Cho), low density lipoprotein-cholesterol (LDL-Cho), and triglyceride (TG) at 8w and 12w, and the amount and rate of changes of them from Scr