Leverontsteking fatty liver Liver inflammation
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - be able to give written informed consent - diagnosed with liver inflammation by a liver biopsy
Exclusion criteria
Exclusion criteria: - age below 18 years or over 75 years - females who are pregnant, breast feeding or who may wish to become pregnant during the study - a significant acute or chronic coexisting illness such as cardiovascular disease, chronic kidney disease, gastrointestinal disorder, endocrinological disorder, immunological disorder, cancer or any condition which contraindicates, in the investigators judgement, entry to the study - a severe medical conditions that might interfere with the study such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel disease and rheumatoid arthritis - use of diuretics or insulin therapy - use of anticoagulants - history of illicit drug use - consumption of more than the recommended alcohol guidelines i.e. >21 alcohol units/week for males and >14 units/week for females - consumption of plant sterol or plant stanol enriched products 1 month before the start of the study (wash-in period) - use of an investigational product in another biomedical study within the previous month - contraindications for MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameter in this study is biopsy proven liver inflammation. | — |
Secondary
| Measure | Time frame |
|---|---|
| - liver inflammation via plasma markers - liver inflammation via MRS - liver inflammation via volatile organic compounds - liver fat via MRS - liver fibrosis via de FibroScan - insulin sensitivity via a hyperinsulinemic-euglycemic clamp - lipid metabolism - glucose metabolism | — |
Countries
Netherlands