Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Capsule containing olive-leaf extract Administration: Take one capsule per day * Daily dose should be taken within the day. If you forget to take the test food, take
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. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician 6. Subjects whose BMI are 23 kg/m2 or more and less then 30 kg/m2 at Scr 7. Subjects whose the visceral fat area are 80 cm2 or more at Scr 8. Men must be randomly selected at least 36 and no more than 40 amoung subjects
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. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," "Foods with Function Claims," or other functional food/beverage in daily use 5. Subjects who are currently taking medications (including herbal medicines) and supplements (especially antidiabetic agent, antihypertensive, and immunosuppressant) 6. Subjects who are allergic to medications and/or the test-food-related products 7. Subjects who are pregnant, lactation, or planning to become pregnant 8. 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 9. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured values of abdominal visceral fat area at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of abdominal visceral fat area at six weeks after consumption (6w) 2. The amount of change of abdominal visceral fat area between screening (before consumption; Scr) and 6w or 12w 3. The measured values and amount of change from Scr in each of the following items at 6w and 12w: abdominal subcutaneous fat area, total abdominal fat area, Chalder Fatigue (CF) score, body weight, body mass index (BMI), abdominal circumference, waist circumference, body fat percentage, fat mass, lean body mass, muscle mass, lactic acid, pyruvic acid, and lactate-to-pyruvate ratio 4. The measured values and amount of change from Scr of growth and differentiation factor 15 (GDF15) at 6w and 12w 5. The each question items of Chalder Fatigue Scale (CFS) at 6w and 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed