K76.0
Conditions
Interventions
Group 1: After following a two week run-in phase, subjects will be given omega 3 supplements (4g p.o. contained in 1 tablet daily) for 4 weeks.
Sponsors
Saarland University Medical Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with non-alcoholic fatty liver disease 2. Patients with the PNPLA3-Genotype (p.148MM and p.I148II)
Exclusion criteria
Exclusion criteria: •Known infection with viral hepatitis, HIV or cholestatic liver diseases (e.g. PBC, PSC). •Presence of Diabetes Mellitus Type 2 (HbA1c = 7.5% (= 58 mmol/mol) •Presence of Alcoholic Fatty Liver Disease with a weekly alcohol consumption of > 21 drinks (> 30 g alcohol/Day) in men and >14 drinks (> 20 g alcohol/Day) in women (2) •Presence of liver cirrhosis based on liver stiffness measurement (transient elastography = 13kPa FibroScan®,Echosens, Paris, France) •Medications known to increase fatty liver (e.g. Amiodarone, Methotrexat) or to affect carbohydrate or lipid metabolism? •Pregnancy •Pacemaker •Vegetarians or vegans
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in hepatic steatosis, as assessed using controlled attentuation parameter (CAP) after 4 weeks of oral omega-3 supplementation | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes to the following paramters after 4 weeks of oral omega 3 supplementation: •Blood lipid profile (Total cholesterol, LDL-C, HDL-C, triglycerides) •Liver function tests (e.g. AST, ALT, GGT, AP, Bilirubin, Albumin) •Inflammatory markers •Fasting plasma glucose, insulin and HbA1c •Liver stiffness measurement (LSM) | — |
Countries
Germany
Contacts
Public ContactCaroline Stokes
Saarland University Medical Center
Outcome results
None listed