Non-alcoholic fatty liver disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Diagnosis of steatosis on transient elastography, conventional ultrasound, magnetic resonance imaging, computed tomography , or by liver biopsy, or identified as steatotic subject by fatty liver index (FLI) algorithm which is based on waist circumference, body mass index, and levels of triglyceride and γ- glutamyltransferase. - 18-70 years of age - BMI
Exclusion criteria
Exclusion criteria: - Acute illness or current evidence of acute or chronic inflammatory or infective diseases - Abusive alcohol use (> 21 IU/week for men, > 14 IU/week for women) - Diagnosed liver cirrhosis and/or hepatocellular carcinoma - Diagnosed cardiorespiratory, neurological or musculoskeletal disease - Diagnosed insulin or GLP-1 agonist treated type 2 diabetes or type 1 diabetes - Hepatitis B and/or C or auto-immune hepatitis - Wilsons disease/ alpha-1-antitripsine deficiency - Hemochromatosis - Untreated hypothyroidism - Lipoatrophy - Bleeding disorder or anti-coagulant use which cannot be temporarily discontinued - Not able or willing to undergo MRI (for example claustrophobia, ICD, pacemaker) - Diagnosed depression or any mental illness rendering the patients unable to understand the nature, scope and possible sequences of the study - Any participation in regular exercise and/or diet program more than 2 times per week in the 3 months prior to recruitment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - NAFL disease progression compared between baseline and after 12 weeks intervention, evaluated by liver biopsy and MRI/MRS scan. This is based on analysis between baseline and endpoint. - Hepatic, muscle and adipose tissue histology and gene expression (evaluated by RNA-sequencing) that is affected by exercise intervention. This is based on liver, muscle and adipose tissue biopsy at baseline and endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Fecal microbial composition variation, evaluated by metagenomic sequencing. This is based on fecal sample at baseline, midway, and endpoint. - Metabolite quantification of plasma and urine samples. This is based on urine samples at baseline and endpoint, and blood samples at baseline, midway and endpoint. | — |
Countries
Netherlands