Healthy volunteers
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Regular user of alcohol (more than 5 days per week) 2) Visceral fat area not lower than 100 cm2
Exclusion criteria
Exclusion criteria: 1) Taking medicines or receiving health guidance for hypertension, diabetes, and/or hyperlipidemia 2) Taking drugs or functional food that may affect the trial 3) Participation in any clinical trial within 90 days of the commencement of the trial 4) In pregnancy or nursing a child 5) Cardiac, renal, and/or hepatic dysfunction 6) History of severe disease and/or major surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visceral fat area at baseline, 8, 12 and 16 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Body weight, body fat percentage, and waist circumference at baseline, 8, 12 and 16 weeks. | — |
Countries
Japan
Contacts
Hiroshima University, Institute of Biomedical & Health Sciences Project Research Center for Clinical Trial and Preventive Medicine