Japanese subjects between 23 kg/m2 or more and less than 30 kg/m2 in BMI
Conditions
Interventions
Duration: 8 weeks Test material: Test food A Dose: Take 3 tablets per day Administration: Take the tablet with a glass of water before each meal * If you forget to take the tablet, take it as so
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese adult subjects between 23 kg/m2 or more and less than 30 kg/m2 in BMI 2. Subjects who are judged as eligible to participate in the study by the physician 3. Subjects who are between 23 kg/m2 or more and less than 25 kg/m2 in BMI or between 25 kg/m2 or more and less than 30 kg/m2 in BMI with less than 100 cm2 in the visceral fat area at screening 4. Within the subjects who met the 2nd and 3rd inclusion criteria, subjects who are relatively high levels of blood glucose at screening
Exclusion criteria
Exclusion criteria: 1. A medical history of malignant tumor, heart failure or myocardial infarction 2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 4. Subjects who have exercise habits more than 3 times per week 5. Subjects who are 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 are pregnant, lactation, or planning to become pregnant 8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 9. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The visceral fat area of umbilicus cross section * Assessed the fat area by X-ray CT * Calculate the amount of change between before consumption and 8 weeks after consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total fat area 2. Subcutaneous fat area 3. Visceral fat area 4. Serum adiponectin 5. Serum total cholesterol 6. Serum HDL cholesterol 7. Serum LDL cholesterol 8. Serum neutral fat (TG: triglyceride) 9. Serum glucose 10. Serum levels of glyceraldehyde-derived advanced glycation end-products 11. Plasma amyloid beta 12. Serum epidermal growth factor 13. Body weight 14. Body mass index 15. Body fat percentage 16. Abdominal circumference 17. Subjective symptoms *1-3 Assessed these by X-ray CT *17 Assessed these symptoms by the Likert scale *1-3 Measure the fat area of umbilicus cross section and calculate the amount of change between before consumption and 8 weeks after consumption. Visceral fat area value will be only measured. *1-17 Assess these tests at screening and examination before consumption and at 4 and 8 weeks after consumption | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed