Japanese subjects between 23 kg/m2 or more and less than 30 kg/m2 in body mass index (BMI)
Conditions
Interventions
Duration: 12 weeks Test material: Active capsule Dose and Administration: Take one capsule per day after breakfast with water or lukewarm water * If you forget to take the capsule, take it as so
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese adult subjects 2. Subjects who are between 23 kg/m2 or more and less than 30 kg/m2 in BMI 3. Subjects who are judged as eligible to participate in the study by the physician 4. Within the subjects who met the 1st to 3rd inclusion criteria, subjects whose visceral fat area assessed by X-ray CT are relatively large
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 5. Subjects who excessive exercise 6. Subjects who are currently taking medications (including herbal medicines) and supplements 7. Subjects who could have any allergens in raw materials of the test food (soybean and gelatin), or possible to have serious allergic reactions to other foods and/or medicines 8. Subjects who are pregnant, lactation, or planning to become pregnant 9. 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 enroll in anther clinical trial during trial period 10. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The visceral fat area in a cross section of the umbilical region * Assess the fat area by X-ray CT * Calculate the amount of change between screening (before consumption) and 12 weeks after consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total fat area 2. Subcutaneous fat area 3. Visceral fat area 4. Body weight 5. Body mass index 6. Body fat percentage 7. Lean body mass 8. Muscle mass 9. Abdominal circumference 10. Basal metabolic rate 11. Abdominal obesity ratio *1-3 Assess these by X-ray CT *1-11 Conduct these at screening (before consumption) and 4, 8, and 12 weeks after consumption. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed