Interventional study
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Overweight/obesity, BMI (kg/m2) >=28; 2) Subjects meet the NAFLD diagnostic criteria in the Guidelines for the Prevention and Treatment of Nonalcoholic Fatty Liver Diseases (Updated 2018); 3) Aged 18 to 70 years old.
Exclusion criteria
Exclusion criteria: 1) (female only) Estrogen therapy or steroid therapy is used currently or once (within 6 months prior to study); corticosteroids for oral or parenteral injections; 2) (limited to female) is currently in pregnancy or lactation; 3) Chronic liver disease caused by chronic viral hepatitis and other causes (such as autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, hereditary hemochromatosis, Wilson's disease, a1-antitrypsin deficiency Disease, celiac disease; 4) Decompensation of cirrhosis; 5) Diseases that require protein intake control; 6) Patients with severe liver and kidney function diseases (the alanine aminotransferase and serum creatinine indicators exceed the normal range set by the hospital by 1.5 times); 7) Anemia; 8) Severe gastrointestinal diseases affecting food digestion and absorption (such as severe diarrhea, constipation, severe gastrointestinal inflammation, active gastrointestinal ulcer, acute cholecystitis/cholecystectomy, etc.); severe diarrhea refers to watery stools 3 times or more per day And lasts for 3 days or more, severe constipation refers to 2 or less bowel movements per week, accompanied by difficulty in defecation; gastrointestinal resection in the past year (except appendicitis, hernia surgery); 9) Drugs or surgery that are undergoing weight loss in the past three months or currently; 10) Diabetic patients; 11) Severe cardiovascular and cerebrovascular disease or stage III hypertension; 12) Secondary obesity caused by endocrine, genetic, metabolic and central nervous system diseases. It is judged by a professional doctor whether it is hypothalamic obesity, pituitary obesity, hypothyroid dysfunction, obesity caused by Cushing's syndrome, and hypogonadism; 13) History of previous malignant tumors; 14) History of infectious diseases such as hepatitis B big three positive, active tuberculosis, AIDS; 15) Anyone with mental illness and recall disorder, epilepsy or anti-epileptic treatment, antidepressants; 16) Use drugs that affect body weight (such as anti-arthritis drugs, receptor blockers, diuretics, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| liver function;Blood lipid;Liver ultrasound;Insulin resistance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body composition; | — |
Countries
China
Contacts
Shanghai Changhai Hospital