Healthy volunteer
Conditions
Sponsors
Maruzen Pharmaceuticals Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Males and females aged of 20-64 years 2)Participants whose BMI 23.0-29.9 kg/m^2 3)Participants who can visit on schedule days 4)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 with, or have a past medical history of dyslipidemia, high blood pressure, or diabetes 3)Participants with a condition that may affect body weight or body fat 4)Participants who joined a weight loss program or similar initiative within three months prior to the start of the screening examination, or participants who experienced significant weight change (a change of 5 kg or more) 5)Participants who received medication treatment or surgery due to serious illness or injury within 1 month prior to the start of this study 6)Participants who regularly use health foods and supplements affecting the study 7)Participants who may have difficulties during CT scanning (e.g. claustrophobia, metal in the vicinity of imaging, implanted medical devices in the body) 8)Possible pregnancy, pregnancy and lactation 9)Heavy drinker (40g alcohol/day or more) 10)Excessive smokers (21 cigarettes/day or more) 11)Participants who feel bad mood by blood collect 12)Participants who donated 200 mL or more of blood within 1 month prior to the start of screening tests or participants who plan to do so during the study period 13)Participants who have been diagnosed with chronic constipation 14)Late-night shift worker 15)Participants who plan business trip or other travel averaging more than 10 days per month 16)Participants who have allergies related to the test foods 17)Participants already participating in other clinical trials, or who plan to participate in other clinical trials during the study period 18)Participants who are ineligible due to physician's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abdominal visceral fat area | — |
Secondary
| Measure | Time frame |
|---|---|
| Abdominal total fat area, abdominal subcutaneous fat area, body weight, BMI, body composition analysis, waist circumference, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, glucose, HbA1c, blood ketone | — |
Countries
Japan
Contacts
Public ContactToyotada Ashino
Trans Genic Inc. Clinical Research Department
Outcome results
None listed