Non-alcoholic fatty liver disease (NAFLD)
Conditions
Interventions
HuoMai peptide group:HuoMai peptide 3g, once daily, oral
Placebo group:Placebo, once daily, oral
Sponsors
Qingdao Third People's Hospital, Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this trial, adhere to the study protocol, and provide written informed consent; 2. Age between 18 and 65 years; 3. Meet the diagnostic criteria for non-alcoholic fatty liver disease (NAFLD): According to the Guidelines for the Prevention and Treatment of Metabolic Dysfunction-Associated (Non-Alcoholic) Fatty Liver Disease (2024 Edition) [1], NAFLD is diagnosed when the following criteria are fulfilled: (a) Imaging evidence of hepatic steatosis and/or liver biopsy showing >=5% macrovesicular steatosis; (b) Presence of at least one component of metabolic syndrome (see Table 1); (c) Exclusion of other causes of hepatic steatosis, including excessive alcohol consumption (defined as >210 g/week for men or >140 g/week for women), malnutrition, Wilson’s disease, and other identifiable etiologies.
Exclusion criteria
Exclusion criteria: 1. Other causes of hepatic steatosis, such as viral hepatitis, autoimmune liver disease, drug-induced liver injury, etc.; 2. Presence of severe complications, such as liver cirrhosis or liver failure; 3. Severe cardiovascular disease, including unstable angina or severe heart failure; 4. Pregnant or lactating women; 5. Long-term use of medications known to affect liver function, such as corticosteroids or other hepatotoxic agents; 6. Participation in an interventional clinical trial within the past 3 months or within 5 half-lives of the investigational product (whichever is longer) prior to screening; 7. Known allergy or hypersensitivity to the investigational drug or any of its components; 8. Presence of psychiatric disorders or language/communication impairments that may interfere with study compliance or assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver fat quantification; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood biochemical indicators;Gut microbiota; | — |
Countries
China
Contacts
Public ContactLiu Zongtao
Qingdao Third People's Hospital, Qingdao University
Outcome results
None listed