Non-alcoholic Fatty Liver Disease Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Este é um ensaio clínico randomizado, duplo-cego e controlado por placebo. Setenta e dois participantes que atendem aos critérios de elegibilidade serão alocados em três grupos de intervenção paralelo
Sponsors
Universidade Federal do Rio de Janeiro
Universidade Federal do Rio de Janeiro
Eligibility
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: Age between 19 and 80 years; diagnosis of metabolic dysfunction-associated steatotic liver disease by abdominal ultrasound and/or liver biopsy within the 24 months prior to the intervention
Exclusion criteria
Exclusion criteria: Hepatitis with detectable viral load; fever or sites of infection; cancer (with or without chemotherapy and radiotherapy); inflammatory diseases of the gastrointestinal tract; transplant, trauma, surgery, or hospitalization within the last 30 days; use of steroids, non-steroidal anti-inflammatory drugs, immunomodulatory agents, or antibiotics; use of omega-3 fatty acid supplements in the 3 months prior to the study; pregnancy and lactation; alcohol intake exceeding 20 grams/day for women and 30 grams/day for men
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study aims to evaluate the percentage change in liver stiffness, expressed in kilopascals (kPa), in patients with non-alcoholic fatty liver disease (NAFLD) after 180 days of intervention, considering three treatment arms: supplementation with eicosapentaenoic acid (EPA)-rich fish oil, supplementation with docosahexaenoic acid (DHA)-rich fish oil, and placebo with olive oil. Liver stiffness will be measured by transient elastography (FibroScan®) at baseline and after 180 days of intervention. The primary outcome will be determined by the percentage change in liver stiffness relative to baseline. A favorable response will be considered a reduction of at least 10% in liver stiffness relative to baseline. The absolute change in kilopascals (kPa) will also be analyzed, and a minimum reduction of 0.70 kilopascals (kPa) after 6 months of intervention will be considered a favorable response | — |
Secondary
| Measure | Time frame |
|---|---|
| Alterations in serum biomarkers of hepatic fibrogenesis are expected, assessed through variations in serum Pro-C3 concentrations and the Enhanced Liver Fibrosis (ELF) score;Changes in the fatty acid composition of erythrocytes, determined by gas chromatography, are expected to be observed in order to evaluate adhesion, incorporation, and biological response to supplementation with omega-3 fatty acids;The study aims to evaluate changes in systemic inflammation markers, quantified using specific immunological methods;The aim is to evaluate changes in oxidative stress markers, quantified by specific biochemical and/or immunological methods;Changes in microRNA (miRNA) expression—determined via reverse transcription followed by quantitative PCR (RT-qPCR) in biological samples collected before and after the intervention—are expected to be observed;Changes in gene expression of Sirtuin 1 (SIRT1) and Sirtuin 3 (SIRT3) are expected to be observed in peripheral blood mononuclear cells (PBMCs), determined by reverse transcription followed by quantitative PCR (RT-qPCR) | — |
Countries
BR
Contacts
Public ContactWilza Peres
Universidade Federal do Rio de Janeiro
Outcome results
None listed