Healthy volunteer
Conditions
Sponsors
New drug research center, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy Japanese males and females aged of 20-64 years 2) Subjects with BMI >=23.0 kg/m2 and <30.0 kg/m2 in screening test 1 3) Subjects with LDL-cholesterol <=159 mg/dL in screening test 1 4) Subjects who can visit on schedule days 5) 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 of dyslipidemia, high blood pressure, or diabetes 3) Subjects who received medication treatment or surgery due to serious illness or injury within 1 month from the start of this study 4) Subjects who regularly use health foods and supplements affecting the study 5) Possible pregnancy, pregnancy, and lactation 6) Heavy drinkers 7) Subjects who have experienced feel bad mood by blood collection 8) 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 9) Subjects who defecate less than once a week 10) Night Rotation worker 11) Subjects who plan business trip or trip for 10 days or more a month 12) Subjects who have allergy related to the test foods 13) Subjects with claustrophobia that interferes with CT scans, subjects with metal in the CT scan measurement site due to surgery, subjects with implanted medical devices such as cardiac pacemakers, implantable cardioverter defibrillators 14) Subjects already participating in other clinical trials 15) Subjects who are ineligible due to physician's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abdominal visceral fat area | — |
Secondary
| Measure | Time frame |
|---|---|
| abdominal subcutaneous fat area, abdominal total fat area, body weight, BMI, body fat percentage, waist circumference, hip circumference, W/H ratio, triceps skinfold thickness, subscapular skinfold thickness, LDL- cholesterol, HDL- cholesterol, L/H ratio, triglyceride, glucose, HbA1c. resting energy expenditure, survey | — |
Countries
Japan
Contacts
Public ContactToyotada Ashino
New drug research center, Inc. Clinical Research Dept.
Outcome results
None listed