Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test food: Food containing lactic acid bacteria Administration: Take one tablet per day in the morning. *If you forget to take the test food, take it as soon as you remember. T
Sponsors
OSAKA SODA CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose BMI is 23 kg/m2 or more and less than 30 kg/m2 at Scr 6. Individuals whose visceral fat area are large at Scr
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) or supplements 6. Individuals who are allergic to medicines or foods related to the test product 7. Individuals who are on a diet 8. Individuals who have an exercise habit 9. Individuals who are pregnant, lactating, or planning to become pregnant during this study 10. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 11. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of the visceral fat area at 12 weeks after intervention (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount and percentage of change of the visceral fat area from screening (before intervention; Scr) to 12w 2. The measured values of total fat area, subcutaneous fat area, body weight, BMI, body fat percentage, fat mass, lean mass, muscle mass (whole body, right leg, left leg, right arm, left arm, and trunk), waist circumference, asparate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltranspeptidase (gamma-GT), total cholesterol (T-Cho), HDL-cholesterol (HDL-Cho), LDL-cholesterol (LDL-Cho), and triglyceride (TG), glucose (GLU), and hemoglobin A1c at 12w, and the amount and percentage of changes of them from Scr 3. The measured values of blood metabolites and RNA blood at 12w, and the amount and percentage of changes of them from Scr | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed