Healthy individuals (Intended indications and effects: Inhibition of visceral fat accumulation)
Conditions
Interventions
Test food: Fermented ginger extract powder
Duration: 12 weeks
Administration: Take one capsule per day in the morning.
Test food: Dextrin
Duration: 12 weeks
Administration: Take one capsule per day i
Sponsors
Takara Tsuyoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Individuals aged 18 to 64 4. Healthy individuals 5. Individuals whose BMI is 25 kg/m^2 or more and less than 30 kg/m^2 6. Individuals whose visceral fat area is relatively large among study participants at screening (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 or undergoing weight loss 8. Individuals who are exercising for diet, weight loss, or muscle building 9. Individuals who exercise at least three times a week 10. Individuals whose lifestyles (particularly dietary habits) are irregular due to working a late-night shift or others 11. Individuals who usually drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} 12. Individuals who are pregnant, lactating, or planning to become pregnant during this study 13. 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 14. 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 visceral fat area at 12 weeks after intervention (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The change and percentage change from Scr of visceral fat area at 12w 2. The measured values of total fat area and subcutaneous fat area at 12w, along with their changes and percentage changes from Scr 3. The measured values of body weight, body mass index, body fat percentage, muscle mass, waist circumference, systolic blood pressure, diastolic blood pressure, total cholesterol (T-Cho), HDL-cholesterol (HDL-Cho), LDL-cholesterol (LDL-Cho), triglycerides (TG), uric acid (UA), aspartate aminotransferase (AST/GOT), alanine aminotransferase (ALT/GPT), gamma-glutamyl transpeptidase (gamma-GT/gamma-GTP), and hemoglobin A1c (HbA1c: NGSP) at 12w, along with their changes and percentage changes from Scr | — |
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc.
Outcome results
None listed