Nonalcoholic fatty liver disease
Conditions
Interventions
Intervention Group:Lycopene was administered orally at a dose of 40mg daily for 12 weeks
Control Group:One pill of the same color dosage form placebo was given orally once a day for 12 weeks
Sponsors
Medical College of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this trial and follow the study protocol, and sign the informed consent form; 2. Aged between 18-65 years; 3. MRI-PDFF>=5%, while excluding excessive alcohol consumption (more than 210g of alcohol per week for men and more than 140g for women), malnutrition, hepatolenticular degeneration and other causes that may lead to fatty liver disease.
Exclusion criteria
Exclusion criteria: 1. Viral hepatitis, autoimmune liver disease, drug-induced liver disease and other causes that may lead to fatty liver; 2. Have serious complications: such as cirrhosis, liver failure, etc.; 3. Severe cardiovascular disease: such as unstable angina, severe heart failure, etc.; 4. Pregnant or lactating women; 5. Long-term use of drugs that may affect the liver: such as long-term use of steroids or other drugs that may affect the liver; 6. Have participated in interventional clinical studies within 3 months or 5 half-lives of study treatment (whichever is longer) before screening; 7. Allergy to the study drug or its components; 8. Those with mental abnormalities or language disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proton Density Fat Fraction(PDFF); | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum triglycerides;Serum cholesterol;AST;ALT;Percentage of body fat;BMI;Waist circumference;FFA;TBA; | — |
Countries
China
Contacts
Public ContactSun Yongye
Medical College of Qingdao University
Outcome results
None listed