Healthy individuals
Conditions
Interventions
Duration: 12 weeks Test food: Tablet containing plant extract Administration: Chew and take one tablet per day with water as needed *If you forget to take the test food, take it as soon as you re
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 and women 3. Adults 4. Healthy individuals 5. Individuals whose BMI is 25 kg/m2 or more and less than 30 kg/m2
Exclusion criteria
Exclusion criteria: 1. Individuals who have a history or current history of serious diseases of the heart, liver, kidneys, digestive organs, etc. 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals 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", "Foods with Functional Claims", or nutritional supplements 5. Individuals who are taking medications (including herbal medicines) and supplements 6. Individuals with allergies to medicines and/or the test food related products 7. Individuals who are heavy smokers (smoking 21 or more cigarettes per day) 8. Individuals who consume excessive alcohol (average daily amount of 40 g or more) 9. Individuals who are shift workers 10. Individuals who have plan for work transfer, long-term business trips, or travel during this study 11. Individuals whose eating habit is irregular 12. Individuals who are on a diet 13. Individuals who are exercising for diet or muscle building 14. Individuals whose exercise habits may change significantly during this study 15. Individuals who are diagnosed with chronic constipation 16. Individuals who are pregnant, lactating, or planning to become pregnant during this study 17. 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 18. 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 consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount of change from before consumption of abdominal visceral fat area at 12w 2. The measured values and the amount of changes from before consumption of abdominal total fat area and abdominal subcutaneous fat area at 12w 3. The measured values and the amount of changes from before consumption of abdominal total fat area, abdominal visceral fat area, and abdominal subcutaneous fat area at 8 weeks after consumption (8w) 4. The measured values of body weight, body mass index (BMI), body fat percentage, fat mass, lean body mass, muscle mass, waist circumference, and Calorie and Nutrition Diary (CAND) at 4 weeks after consumption (4w), 8w, and 12w 5. The amount of changes from before consumption of body weight, BMI, body fat percentage, fat mass, lean body mass, muscle mass, waist circumference, and CAND at 4w, 8w, and 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed