Healthy Japanese subjects
Conditions
Interventions
Duration: 8 weeks Test food: Test tablets Administration: Take 3 tablets once a day with water and 30 minutes before lunch or dinner without chewing. * If you forget to take the test food, take i
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese adult subjects who are between 25 kg/m2 or more and less than 30 kg/m2 in BMI 2. Subjects who are judged as eligible to participate in the study by the physician 3. Meeting the 1st and 2nd criteria requirements, subjects whose visceral fat area in a cross section of the umbilical region, assessed by X-ray CT, are less than 100 cm2 4. Meeting the 1st to 3rd criteria requirements, subjects whose visceral fat area in a cross section of the umbilical region, assessed by X-ray CT, are relatively large
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed