Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test food: Food containing plant-derived ingredients
Duration: 12 weeks Test food: Placebo food
Sponsors
Pharma Foods International Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose BMI is 25 kg/m2 or more and less than 30 kg/m2 at Scr 6. Individuals whose abdominal visceral fat area are 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 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 and foods related to the test product 7. Individuals who consume excessive alcohol (average daily amount of 60 g or more) 8. Individuals who are on a diet or undergoing weight loss 9. Individuals who are exercising for diet, weight loss, or muscle building 10. Individuals who exercise at least three times per week 11. Individuals whose lifestyles (particularly dietary habits) are irregular due to working a late-night shift or others 12. Individuals who are on extreme diets, such as "no carbohydrates at all" 13. Individuals who are pregnant, lactating, or planning to become pregnant during this study 14. 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 15. 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 abdominal visceral fat area at 12 weeks after intervention (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount and percentage of change of abdominal visceral fat area at 12w from screening (before intervention; Scr) 2. The measured values of abdominal visceral fat area at 4 weeks after intervention (4w) and 8 weeks after intervention (8w), and the amount and percentage of changes of it from Scr 3. The measured values of total fat area, subcutaneous fat area, body weight, body mass index (BMI), body fat percentage, waist circumference (W), hip circumference (H), fat mass, lean body mass, muscle mass, W/H ratio, total cholesterol (T-Cho), high density lipoprotein-cholesterol (HDL-Cho), low density lipoprotein-cholesterol (LDL-Cho), triglyceride (TG), Glucose (GLU), and hemoglobin A1c (HbA1c) at 4w, 8w and 12w, and the amount and percentage of changes of them from Scr | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed