Healthy Japanese
Conditions
Interventions
functional food A Daily intake: 250 mg Duration: 84 days
functional food A Daily intake: 750 mg Duration: 84 days
functional food A Daily intake: 2,250 mg Duration: 84 days
functional food
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose BMI are 25 kg/m2 or more and less than 30 kg/m2 at screening (before intervention; Scr) 6. Individuals whose 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 or foods related to the test products 7. Individuals who are on a diet 8. Individuals who have an exercise habit 9. Individuals whose lifestyles (particularly dietary habits) are irregular due to working a late-night shift or others 10. Individuals who plan to have surgery during this study and within two weeks after this study 11. Individuals who are pregnant, lactating, or planning to become pregnant during this study 12. 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 another study during this study 13. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visceral fat area | — |
Secondary
| Measure | Time frame |
|---|---|
| Subcutaneous fat area, total fat area, body weight, body fat percentage, body mass index (BMI), waist circumference, fat mass, lean mass, and muscle mass | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed