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: Capsules containing malted rice Dose: Take 2 capsules per day Administration: Take 2 capsules with water or warm water after breakfast * If you forget to take c
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. Within the subjects who met the 1st and 2nd inclusion criteria, subjects whose visceral fat area of umbilicus cross section are relatively large
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, endometriosis, uterine myoma, and mental disorders 2. 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 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 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. Serum adiponectin level 5. Serum total cholesterol level 6. Serum HDL-cholesterol level 7. Serum LDL-cholesterol level 8. Serum neutral fat (TG: triglyceride) level 9. Serum glucose level 10. Height 11. Body weight 12. Body mass index 13. Body fat percentage 14. Body temperature 15. Abdominal circumference 16. Muscle mass 17. Basal metabolic rate 18. Subjective symptoms (A questionnaire) *1-9, 11-18 Assess these tests at screening (before consumption) and at 12 weeks after consumption *10 Measure the height only at screening (before consumption) *1-2 Assess these by X-ray CT. Measure the fat area of umbilicus cross section and calculate the amount of change between screening (before consumption) and 12 weeks after consumption. *3 Assess the measured value of the fat area in a cross section of the umbilical region by X-ray CT. *4-9, 11-17 Measure the items and calculate the amount of change between screening (before consumption) and 12 weeks after consumption. *18 Assess symptoms by the Likert scale. Each item is assessed with a six-point grading scale from 1 (strongly disagree) to 6 (strongly agree). The smaller number indicates better condition. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed