Patients with non-alcoholic fatty liver disease (NAFLD)/metabolically associated fatty liver disease (MAFLD) and patients with mild cirrhosis
Conditions
Interventions
Control group:Equal-dose placebo (food with the same appearance and taste as the experimental group)
Intervention group:IL-27 receptor-related food and medicine with the same origin (rich in IL-27 receptor small molecule agonists) combined with specific probiotics for intervention
Sponsors
The First People's Hospital of Qinzhou
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.No gender restriction, age >= 18 years old, = 18 years old and <= 70 years old); 2.BMI 25-40 kg/m^2; 3.Diagnosed as NAFLD/MAFLD through ultrasound/MRI/biopsy; 4.Mild abnormal liver function (ALT 1-3 times the upper limit of normal);
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. ECG findings suggesting possible undiagnosed cardiac disease requiring further evaluation (e.g., significant conduction abnormalities, arrhythmias); 3. Prior definite diagnosis of cardiac disease (coronary artery disease, rheumatic heart disease, cardiomyopathy, heart failure) or cerebrovascular disease (intracerebral hemorrhage, cerebral infarction); 4. Prior chronic kidney disease (chronic glomerulonephritis, chronic renal insufficiency, systemic diseases involving the kidneys); diabetic nephropathy; creatinine level >1.5 times the upper limit of normal (local laboratory); 5. Acute gouty arthritis attack; or patients with more than 3 attacks per year; 6. Hypertensive patients with systolic blood pressure >180 mmHg and/or diastolic blood pressure >=100 mmHg (excluding those well-controlled on antihypertensive medication); 7. Thyroid disease currently under treatment (particularly hyperthyroidism or hypothyroidism); 8. Malignant tumor; 9. Severe peptic ulcer and frequent gastroesophageal reflux; 10. Patients with acute pancreatitis within 1 month of onset or recurrent chronic pancreatitis; 11. Patients with frequent hypoglycemic episodes; 12. Psychiatric disorders (e.g., depression, bipolar disorder, binge eating disorder); 13. Post-surgical recovery not yet complete; 14. Other causes of liver disease (active hepatitis B/C, alcoholic hepatitis without abstinence); 15. Severe complications (HCC, renal insufficiency, portal vein thrombosis); 16. Concurrent use of immunosuppressants or contraindications to trial drugs; 17. Currently participating in other interventional trials; 18. Unable to communicate with health management specialists via internet or phone; 19. For any severe or acute disease not covered above, or any condition that cannot be clearly assessed, relevant medical records must be provided for evaluation by the expert panel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver fiber hardness, dynamic changes of intestinal flora and long-term safety indicators;Biochemical indicators Fasting plasma glucose (FPG), fasting insulin (FINS), glycated hemoglobin (HbA1c), blood routine (white blood cells, red blood cells, platelets, hemoglobin), liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct bilirubin, indirect bilirubin), renal function (urea nitrogen, creatinine, urine acid, cystatin) C) Blood lipids (total cholesterol TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotei;Physical parameters: BMI; Waist-to-hip ratio Height; Weight; Waist circumference Hip circumference Blood pressure; Heart rate; | — |
Countries
China
Contacts
Public ContactLu Yongguang
The First People's Hospital of Qinzhou
Outcome results
None listed