Metabolic Dysfunction-Associated Fatty Liver Disease
Conditions
Interventions
Treatment group:Fucoxanthin 4mg/d
Control group:Placebo
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–75 years (inclusive); 2. Meet the diagnostic criteria for metabolic dysfunction-associated fatty liver disease (MAFLD/MASLD), with reference to the Clinical Practice Guidelines for the Management of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) jointly published by EASL/EASD/EASO in 2024; 3. Hepatic fat content >=8% as measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF) during the screening period; 4. FIB-4 index <1.3 during the screening period.
Exclusion criteria
Exclusion criteria: 1. History of substantial alcohol consumption within the past 3 months (weekly ethanol intake >=210 g for males and >=140 g for females); 2. Body weight fluctuation >=5% within the past 3 months; 3. History of fatty liver disease caused by other conditions, including chronic viral hepatitis, Wilson disease, autoimmune hepatitis, and other etiologies; 4. Use of medications known to cause fatty liver disease or agents with potential hepatoprotective or weight-reducing effects within 3 months prior to screening; 5. Unstable endocrine disorders affecting body weight and hepatic function, such as thyroid diseases; 6. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >3× upper limit of normal (ULN) at screening; 7. Renal impairment with estimated glomerular filtration rate (eGFR) 9.0%); 11. Known hypersensitivity to fucoxanthin or any excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Magnetic resonance imaging proton density fat fraction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver Serum Marker;Controlled attenuation parameter;Resting Metabolic Rate;Lean Body Mass;Body Fat Mass;Body Fat Percentage;Alanine aminotransferase;Aspartate aminotransferase;Total Cholesterol;Triglycerides;High-Density Lipoprotein Cholesterol (HDL-C);Low-Density Lipoprotein Cholesterol (LDL-C);Fasting Plasma Glucose;Fasting Insulin;FIB-4 index;Homeostatic Model Assessment of Insulin Resistance;TNF-a;IL-6;High sensitivity C-reactive protein,hs-CRP;Weight;Waist circumference; | — |
Countries
China
Contacts
Public ContactGuo Lixin
Beijing hospital
Outcome results
None listed