Healthy and overweight Japanese adult 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: Tablet containing sugars (high dose) Dose and Administration: Take 1 tablet, three times per day before each meal with water * If you forget to take the tablet,
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy subjects 2. Japanese adult subjects 3. Subjects who are between 23 kg/m2 or more and less than 30 kg/m2 in BMI 4. Subjects who are judged as eligible to participate in the study by the physician 5. Meeting the 1st to 4th criteria requirements, subjects whose visceral fat area, assessed by X-ray CT, are relatively large with less than 100 cm2, or more than 100 cm2
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 excessive exercise 5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 6. Subjects who are currently taking medications (including herbal medicines) and supplements 7. Subjects who are an allergic reaction to medications and/or products that contain the study ingredients 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 ineligibility to participate in the study based on the evaluation of the principal 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. Body water 9. Muscle mass 10. Abdominal circumference 11. Basal metabolic rate 12. Waist circumference 13. Hip circumference 14. Abdominal obesity ratio 15. Subjective symptoms (the Likert scale) *1-3 Assess these by X-ray CT of the umbilical region *1, 2 Compare the measured values at screening (before consumption) and at 12 weeks after consumption and calculate the amount of change *3 Compare the measured values between screening (before consumption) and 12 weeks after consumption *4-15 Compare the measured values at screening (before consumption) and at 4, 8, and 12 weeks after consumption and calculate the amount of change | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed