Healthy volunteer
Conditions
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Healthy Japanese males and females aged 20 to 39 years-old 2)Participants with a BMI >=23 and < 30 in screening test 3)Participants who are judged to take a lot of fat according to the FFQg in the preliminary investigation 4)Participants who have received sufficient explanation of the purpose and content of the study, have the ability to consent, voluntarily applied to participate in the study based on good understanding, and have agreed to participate in the study in writing
Exclusion criteria
Exclusion criteria: 1)Participants who are under treatment of severe illness in the liver, kidney, digestive organs, heart, respiratory, endocrine, thyroid, adrenal, or other metabolic 2)Participants who are implanted with a cardiac pacemaker or a defibrillator 3)Participants who are implanted with metal in the CT scan measurement area 4)Claustrophobic 5)Participants who have food allergies 6)Participants who have gastrointestinal diseases or a history of gastrointestinal surgery that affects digestion and absorption (excluding appendicitis) 7)Participants who have a history or current condition of drug or alcohol dependence 8)Smorkers 9)Participants using medications that may affect obesity, hyperglycemia, hyperlipidemia, or lipid metabolism 10)Participants who cannot refrain from consuming health foods or supplements that may affect obesity, hyperglycemia, hyperlipidemia, or lipid metabolism during the study period 11)Participants who regularly use intestinal regulator or laxatives(excluding who can stop using in the study period ) 12)Participants who cannot abstain from alcohol from the day before each test until the end of the test 13)Participants who drink more than approximately 40 g/day of pure alcohol on four or more days a week 14)Participants who are judged to be muscular in the screening test 15)Participants who are ineligible due to physician's judgment in the screening test 16)Participants who are judged to have chronic constipation in the preliminary investigation 17)Participants who have donated more than 200 mL of blood and/or component blood within one month or more than 400 mL within three months of consent in this study 18)Participants who feel bad mood by blood collect 19) Participants who have extremely irregular eating habits or are shift workers or night workers. 20)Pregnancy, lactation and possible pregnancy 21)Participants already or possible participating in other clinical trials 22)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, waist circumference/hip circumference, total cholesterol, LDL- cholesterol, HDL- cholesterol, triglyceride, glucose, HbA1c | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Clinical Trial Management department
Outcome results
None listed