Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Tablet containing proanthocyanidins derived from Acacia Bark Administration: Take six tablets before meal with water without chewing *If you forget to take the test
Sponsors
ORTHOMEDICO Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects 5. Subjects whose BMI are 25 kg/m2 or more and less than 30 kg/m2 6. Subjects whose the visceral fat area are relatively large 7. Subjects who are judged as eligible to participate in the study by the physician
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who have severe anemia 5. Subjects who drink a large amount of alcohol or excessively smoke 6. Subjects whose life rhythms are irregular due to working a late-night shift or others 7. Subjects who intensely exercise 8. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 9. Subjects who are currently taking medications (including herbal medicines) and supplements 10. Subjects who are allergic to medicines and/or the test food related products 11. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 12. Subjects who suffer from COVID-19 13. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 14. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The abdominal visceral fat area at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The abdominal visceral fat area at four and eight weeks after consumption (4w and 8w), and at four weeks after completed consumption (a4w) 2. The abdominal total fat area, the abdominal subcutaneous fat area, body weight, body mass index (BMI), body fat percentage, fat mass, muscle mass, abdominal circumference, waist circumference, hip circumference at 4w, 8w, 12w, and a4w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed