Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Capsules containing 10-hydroxy-cis-12-octadecenoic acid (HYA) Administration: Take three capsules (HYA 100 mg/capsule) three times a day before each meal with water.
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 than 30 kg/m2 at screening 7. Subjects whose the visceral fat area is relatively high at screening
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 who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 5. Subjects who currently taking medications (including herbal medicines) and supplements. 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who could have allergic to gelatin 8. Subjects who are judged to be inappropriate as subjects based on their responses to the lifestyle questionnaire. 9. Subjects who are pregnant, lactation, or planning to become pregnant 10. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 11. 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 four and eight weeks after consumption (4w, 8w) 2. The amount of change of abdominal visceral fat area between screening (before consumption; Scr) and 4w, 8w, or 12w 3. The measured values of abdominal subcutaneous fat area, total abdominal fat area, body weight, body mass index (BMI), abdominal circumference, waist circumference, body fat percentage, fat mass, lean body mass, muscle mass, Glucagon-like peptide-1, peptide YY, and insulin at 4w, 8w, and 12w 4. The amount of change of abdominal subcutaneous fat area, total abdominal fat area, body weight, body mass index (BMI), abdominal circumference, waist circumference, body fat percentage, fat mass, lean body mass, muscle mass, Glucagon-like peptide-1, peptide YY, and insulin between Scr and 4w, 8w, and 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed