Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test product: Test Food
Duration: 12 weeks Test product: Placebo
Sponsors
UNIAL Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals with a BMI >= 23 kg/m2 and < 30 kg/m2 at screening 6. Individuals with a large abdominal visceral fat area at screening
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are 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. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) or supplements 6. Individuals who are allergic to medicines or foods related to the test product, particularly those with iodine allergy 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 9. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Measured value of visceral fat area at 12 weeks after intervention (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Measured values of total fat area, subcutaneous fat area, body fat percentage, and waist circumference at 12w 2. Measured values of total cholesterol (T-Cho), HDL-cholesterol (HDL-Cho), LDL-cholesterol (LDL-Cho), triglycerides (TG), glucose (GLU), and hemoglobin A1c (HbA1c: NGSP) at 12w 3. Individuals who experienced adverse events 4. Individuals whose urinalysis or peripheral blood test values were outside the reference range after intervention, despite being within the reference range at screening 5. Physical measurements, urinalysis, and peripheral blood test | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed