Effects of consumption of the test food in healthy Japanese normal to overweight subjects: a randomized, double-blind, placebo-controlled, parallel-group trial
- Conditions
- Japanese subjects between 23 kg/m2 or more and less than 30 kg/m2 in body mass index (BMI)
- Registration Number
- JPRN-UMIN000033236
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, endometriosis, uterine myoma, and mental disorders 2. 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 3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 4. Subjects who have exercise habits more than 3 times per week 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines 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 three months before the agreement to participate in 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 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