Healthy subjects
Conditions
Sponsors
Trans Genic Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Healthy Japanese males and females aged of 20-64 years 2)Subjects with BMI >=25.0 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 have been diagnosed with dyslipidemia,high blood pressure,or diabetes or are taking medication 3)Subjects who received medication treatment or surgery due to serious illness or injury within 1 month from the start of this study(excluding those prescribed for temporary symptoms such as colds,pollen,etc.) 4)Subjects who regularly use"Foods for Specified Health Uses","Foods with Functional Claims",or nutritional supplements 5)Possible pregnancy,pregnancy,and lactation during the study 6)Heavy drinkers of alcohol(average daily amount of 40g or more),excessive smokers(more than 21 cigarettes/day) 7)Subjects who have experienced feel bad mood or worsening of physical condition by blood collection 8)Subjects with systolic blood pressure less than 90mmHg 9)Subjects who donated 200mL or more of blood within 1month from the start of the study or subjects who plan to do so during the study period 10)Subjects who have been diagnosed with chronic constipation 11)Shift workers or late-night workers whose work schedule exceeds 0:00 AM 12)Subjects who plan business trip or trip on average more than 10days per month(excluding Obon vacation and New Year's holidays) 13)Subjects who may have allergy symptoms to any of the ingredients contained in the test food 14)Subjects who are already participating in other clinical trials,those who plan to participate during this study period,and those within one month after the completion of the trial in which they participated
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 (measured value and amount of change) | — |
Countries
Japan
Contacts
Public ContactToyotada Ashino
Trans Genic Inc. Clinical Research Department
Outcome results
None listed