Healthy Japanese subjects
Conditions
Interventions
Duration: 8 weeks Test food: Test food A Administration: Take 4 capsules, once per day at any time during the day. *Daily dose must be taken within the day.
Duration: 8 weeks Test food: Placebo
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy adults 2. Japanese subjects between >=23 kg/m2 and <30 kg/m2 in body mass index (BMI) 3. Subjects who are judged as ineligible to participate in the study by the physician 4. Subjects who have relatively large abdominal circumference at screening 5. Subjects who are between >=23 kg/m2 and <25 kg/m2 in BMI or between >=25 kg/m2 and <30 kg/m2 in BMI with <85 cm for men and <90cm for women in the abdominal circumference at screening
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, obesity or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 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 allergic to citrus fruits. 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 participate another trial during this trial 10. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abdominal circumference *Assess the measured value at screening (before consumption) and at 4 and 8 weeks after consumption or calculate the amount of change. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Body weight 2. Body fat percentage 3. Muscle mass 4. Lean body mass 5. Upper arm circumference diameter 6. Thigh circumference diameter 7. Hip circumference diameter 8. Body mass index 9. Waist-to-hip ratio 10. Subjective symptoms (The Likert scale method) *1-9 Assess the measured value at screening (before consumption) and at 4 and 8 weeks after consumption or calculate the amount of change. *10 Assess the measured value at screening (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