Healthy volunteer
Conditions
Sponsors
Maruzen Pharmaceuticals Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese Males and females aged of 20-64 years 2. Subjects with BMI 25-29.9 kg/m2 3. Subjects who can visit on schedule days 4. Subjects who recognize the object and contents of the study and submit the written informed consent
Exclusion criteria
Exclusion criteria: 1. Subjects who are under treatment or have a history of severe illness in the heart, liver, kidney, digestive organs or other organs 2. Subjects who are under treatment or have a history of dyslipidemia, high blood pressure, or diabetes 3. Subjects who are under treatment that may affect weight 4. Subjects who have significant weight change within 3 months of the start of the study 5. Subjects who participated in weight loss programs, etc. within 3 months of the start of the study 6. Subjects who received medication treatment or surgery due to serious illness or injury within 1 month from the start of this study 7. Subjects who underwent surgery due to illness or injury within 6 months of the start of the study, and subjects who underwent obesity surgery within 1 year 8. Subjects who regularly use health foods and supplements affecting the study 9. Possible pregnancy, pregnancy, and lactation 10. Heavy drinkers 11. Subjects who feel bad mood by blood collect 12. Subjects who donated 200 mL or more of blood within 1 month from the start of the study or subjects who plan to do so during the study period 13. Subjects who have some metal inside the body 14. Shift worker 15. Subjects who plan business trip or trip for 10 days or more a month 16. Subjects who have allergy related to the test foods 17. Subjects who have thyroid stimulating hormone of 10 mIU/L or more, creatinine of 1.5 mg/dL or more, and AST or ALT of more than 3 times the upper limit of clinical laboratory standard value. 18. Subjects already participating in other clinical trials 19. Subjects who are ineligible due to physician's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| body fat mass (DEXA) | — |
Secondary
| Measure | Time frame |
|---|---|
| lean mass/body fat percentage/bone mineral density(DEXA), waist circumference, hip circumference, W/H ratio, body weight, BMI, soft Lean mass/body fat mass/body fat percentage/segmental lean mass/extracellular water ratio/basal metabolic expenditure(Impedance method), total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, glucose, HbA1c | — |
Countries
Japan
Contacts
Public ContactTomoya Yuhki
New drug research center, Inc. Clinical Research Dept.
Outcome results
None listed