Healthy subjects
Conditions
Interventions
Intake of test food 1 for 12 weeks
Intake of test food 2 for 12 weeks
Intake of placebo food for 12 weeks
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 3) Subjects who can visit the study institution on schedule days 4) Subjects who recognize the object and content of the study and have given their consent in writing before the study begins
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 this study 5) Possible pregnancy, pregnancy, and lactation 6) Heavy drinkers, excessive smokers 7) Subjects who have experienced feel bad mood by blood collection 8) Subjects with systolic blood pressure less than 90 mmHg 9) Subjects who donated 200 mL or more of blood within 1 month from the start of this study or those who plan to do so during this study 10) Subjects who have been diagnosed with chronic constipation 11) Shift workers or late-night workers 12) Subjects who plan business trip or trip on average more than 10 days per month 13) Subjects who may have allergy to the ingredients contained in the test food 14) Subjects who are participating in other clinical trials, those who plan to participate during this study, and those within 1 month after the trial in which they participated 15) Subjects whose exercise habits may change significantly, those who regularly engage in strenuous exercise and those who on a diet 16) Subjects with extremely irregular eating habits 17) 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 18) Subjects who fail to comply with the requests to subjects during the study period 19) Subjects who are ineligible due to physician's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| abdominal total fat area (amount of change) | — |
Secondary
| Measure | Time frame |
|---|---|
| abdominal total fat area (measured value), abdominal visceral fat area, abdominal subcutaneous fat area, body weight, body mass index (BMI), body fat percentage, muscle mass (overall), waist circumference, hip circumference, femoral circumference, upper arm circumference, insulin, CRP, adiponectin, leptin (measured value and amount of change) | — |
Countries
Japan
Contacts
Public ContactToyotada Ashino
New drug research center, Inc. Clinical Research Dept.
Outcome results
None listed