Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Drink containing beta-hydroxybutyric acid (BHB) Administration: Drink one bottle after breakfast * Daily dose should be taken within the day. If you forget to take
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician 6. Subjects whose BMI are 23 kg/m2 or more and less than 30 kg/m2 at Scr 7. Subjects whose the visceral fat area are relatively large
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 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 have exercise habits three times or more per week 8. Subjects who work late-night shifts and the erratic lifestyle (particularly dietary habits) 9. Subjects who are on excessive dietary restriction, such as not eating carbohydrates at all 10. Subjects who are on a diet 11. Subjects who are pregnant, breast-feeding, and planning to become pregnant 12. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 13. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured values of abdominal visceral fat area at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount of change of abdominal visceral fat area between screening (before consumption; Scr) and 12w 2. The measured values in each of the following items at 12w: abdominal subcutaneous fat area, total abdominal fat area, body weight, body mass index (BMI), abdominal circumference, waist circumference, body fat percentage, fat mass, lean body mass, muscle mass, total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglyceride (TG), and original questionnaires 3. The amount of change from Scr in each of the following items at 12w: abdominal subcutaneous fat area, total abdominal fat area, body weight, BMI, abdominal circumference, waist circumference, body fat percentage, fat mass, lean body mass, muscle mass, total cholesterol, HDL cholesterol, LDL cholesterol, TG | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed