Healthy volunteer
Conditions
Sponsors
Maruzen Pharmaceuticals Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese males and females aged of 20-54 years 2) Participants whose BMI >=23.0 kg/m2 and <30.0 kg/m2 3) Participants who take a lot of fat 4) Participants who can visit on schedule days 5) Participants who recognize the object and contents of the study and submit the written informed consent
Exclusion criteria
Exclusion criteria: 1) Participants who are under treatment or have a history of severe illness in the heart, liver, kidney, digestive organs or other organs 2) Participants who have been diagnosed or taking medication with dyslipidemia, high blood pressure, or diabetes 3) Participants who received medication treatment or surgery due to serious illness or injury within 1 month prior to the start of the study 4) Participants who regularly use health foods and supplements affecting the study 5) Participants who may have difficulties during CT scanning (e.g. claustrophobia, metal in the vicinity of imaging, implanted medical devices in the body) 6) Possible pregnancy, pregnancy and lactation 7) Heavy drinker (over 40g alcohol/day) 8) Smokers 9) Participants who feel bad mood by blood collect 10) Participants who donated 200 mL or more of blood within 1 month prior to the start of the study or participants who plan to do so during the study period 11) Participants who have been diagnosed with chronic constipation 12) Late-night Shift worker 13) Participants who plan business trip or trip on average more than 10 days per month (excluding Obon vacation and New Year's holidays) 14) Participants who have allergy related to the test foods 15) Participants already participating in other clinical trials 16) Participants 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, waist circumference, hip circumference, W/H ratio, total cholesterol, LDL- cholesterol, HDL- cholesterol, triglyceride, glucose, HbA1c | — |
Countries
Japan
Contacts
Public ContactToyotada Ashino
Trans Genic Inc. Clinical Research Department
Outcome results
None listed