Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test product: Test food (Dose-1)
Duration: 12 weeks Test product: Test food (Dose-2)
Duration: 12 weeks Test product: Placebo
Sponsors
J-OIL MILLS, Inc.
Chiba University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose BMI is 23 kg/m2 or more and less than 30 kg/m2 at Scr 6. Individuals whose visceral fat area by X-ray CT scan is relatively large at Scr
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 cannot regularly take three meals (breakfast, lunch, and dinner) a day 5. Individuals who take dairy products such as milk or cheese at least four times a week 6. Individuals who are restricting their diet or exercising for the purpose of dieting 7. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 8. Individuals who are taking or using medications (including herbal medicines) or supplements 9. Individuals who are allergic to medicines or foods related to the test product, particularly those who are allergic to gelatin 10. Individuals who are pregnant, lactating, or planning to become pregnant during this study 11. 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 12. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of visceral fat area at 12 weeks after intervention (12w) [Dose-1 group vs. placebo group] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount of change from screening (Scr) of visceral fat area at 12w [Dose-1 group vs. placebo group] 2. The measured values and amount of changes from Scr of total fat area and subcutaneous fat area at 12w [Dose-1 group vs. placebo group] 3. The measured values and amount of changes from Scr of total fat area, visceral fat area, and subcutaneous fat area at 12w [Dose-2 group vs. placebo group] 4. The measured values and amount of changes from Scr of body weight, body mass index (BMI), body fat percentage, muscle mass, grip strength (dominant hand and not-dominant hand), total cholesterol (T-Cho), low density lipoprotein-cholesterol (LDL-Cho), high density lipoprotein-cholesterol (HDL-Cho), and triglyceride (TG) at 12w [Dose-1 group vs. placebo group and Dose-2 group vs. placebo group] 5. Individuals who experienced adverse events 6. Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at Scr 7. Anthropometric measurement, urinalysis, and peripheral blood test | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed