Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test food: A plant-derived food Administration: Take three tablets once per day with water immediately before snack or dinner. *If you forget to take the test food, take it as
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. Individuals aged 20 or more and less than 65 4. Healthy individuals 5. Individuals who receive a comprehensive explanation of this study, can understand it, and provide a informed consent signed by themselves 6. Individuals who have a habit of snacking (habit of taking foods containing fructose) 7. Individuals who have a high intake of fructose in the dietary survey since three days before Scr 8. Individuals whose BMI are 23 kg/m2 or more and less than 30 kg/m2 at Scr 9. Individuals whose waist circumference is large at Scr
Exclusion criteria
Exclusion criteria: Individuals (who/whose) 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. 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. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. take herb or foods with hypoglycemic effects 6. are taking medications (including herbal medicines) and supplements 7. are allergic to medicines and/or the test food related products 8. notice a weak stomach and may feel discomfort such as convergence in the stomach, particularly when taking beverages containing tannin such as green tea, black tea, or coffee 9. have irregular lifestyles (such as diet, exercise, and sleep) 10. weekly average of pure alcohol intake is more than 60 g/day 11. are pregnant, lactating, or planning to become pregnant during this trial 12. 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. have donated blood component or 200 mL whole blood within the last one month before the agreement to participate in this trial 14. have donated 400 mL whole blood within the last three month before the agreement to participate in this trial 15. are scheduling to have a total of more than 1,200 mL of blood drawn until the end of this study from the 12 months before the date of consent obtained 16. are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of waist circumference at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of waist circumference at eight weeks after consumption (8w) 2. The amount and rate of changes of waist circumference between screening (before consumption; Scr) and 8w, or 12w 3. The measured values of body weight, body mass index (BMI), body fat percentage, hip circumference, thigh circumference, lean body mass, muscle mass, fat mass, total cholesterol (T-Cho), high density lipoprotein-cholesterol (HDL-Cho), low density lipoprotein-cholesterol (LDL-Cho), and triglyceride (TG) at 8w and 12w, and the amount and rate of changes of them from Scr | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed