metabolic dysfunction-associated fatty liver diseas
Conditions
Interventions
Intervention Group:Oral Guanzhuosan capsule fermented tea based on unified lifestyle guidance
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–70 years, voluntarily participating in this study and signing the informed consent form; 2. Meet the diagnostic criteria for metabolism-related fatty liver disease, namely: (1) Imaging evidence suggesting hepatic steatosis: transient elastography (FibroScan) indicates hepatic steatosis, and the controlled attenuation parameter (CAP) >= 248 dB/m; (2) Accompanied by at least one metabolic abnormality indicator, including but not limited to: 1) Overweight or obesity (BMI >= 24 kg/m^2); 2) Waist circumference: male >= 90 cm, female >= 85 cm; 3) Abnormal blood glucose: fasting blood glucose >= 6.1 mmol/L, or 2-hour post-load blood glucose >= 7.8 mmol/L, or a history of type 2 diabetes; 4) Dyslipidemia: fasting plasma triglycerides >= 1.7 mmol/L (>= 150 mg/dl) or currently receiving lipid-lowering treatment; high-density lipoprotein: male = 130/85 mmHg or currently receiving antihypertensive treatment. 3. Good liver function compensation and able to cooperate with follow-up and related examinations.
Exclusion criteria
Exclusion criteria: 1. Women with alcohol consumption >140 grams/week, men with alcohol consumption >210 grams/week; 2. Indications of a high likelihood of advanced liver fibrosis, such as LSM >12 kPa; already confirmed diagnosis of cirrhosis, portal hypertension, or liver function decompensation; 3. Chronic liver diseases caused by other definite etiologies, including but not limited to viral hepatitis, autoimmune liver diseases, drug-induced liver injury, genetic metabolic liver diseases, etc.; 4. Severe concomitant conditions such as serious cardiovascular or cerebrovascular diseases or renal insufficiency; 5. Pregnant or breastfeeding women; 6. Newly initiated or adjusted medications or supplements within the past 3 months that may significantly affect body weight/hepatic lipid metabolism; 7. Other situations deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Controlled Attenuation Paramete; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lifestyle Intervention Adherence;Adherence to Fermented Tea Intervention;Body Fat Percentage;Visceral fat index;body mass index;Uric acid;Adverse Events;Fasting Blood Glucose;Total Cholesterol;High-Density Lipoprotein Cholesterol;Blood Urea Nitrogen;Triglyceride;Waist circumference;Serum Creatinine;aspartate aminotransferase;Body weight;eGFR;alanine aminotransferase;Low-Density Lipoprotein Cholesterol;?-Glutamyl Transpeptidase; | — |
Countries
China
Contacts
Public ContactJunyu Bian
Shanghai Public Health Clinical Center
Outcome results
None listed