leverontsteking fatty liver Liver inflammation
Conditions
Interventions
All children will be randomly allocated to consume control or plant stanol
ester enriched soft chews on a daily basis for a period of 6
months. After 12 months there will be an additional blood sampl
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: - Participation in the COACH lifestyle intervention - Aged below 18 years - Be able to give written informed consent - ALT concentrations more than 1.5 times the upper limit of normal (>39 U/L for boys and >33 U/L for girls) - Willingness to consume 6 soft-chews (2 at breakfast, 2 at lunch and 2 at diner) on a daily basis for a period of 6 months
Exclusion criteria
Exclusion criteria: - Have a severe medical conditions which contraindicates, in the investigators judgement, entry to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameter in this study is the change in plasma ALT concentration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary study parameters: - Effect of plant stanol ester consumption on liver function (AST, GGT, bilirubin CK18) and non-invasive plasma markers of liver inflammation (cathepsin-D and acid phosphatase) - Effect of plant stanol ester consumption on degree of liver steatosis, assessed with HRI measurement during abdominal ultrasonography; - Effect of plant stanol ester consumption on degree of liver fibrosis, assessed with transient elastography, using a FibroScan; - Effect of plant stanol ester consumption on lipid and lipoprotein metabolism (cholesterol, triacylglycerol, (apo)lipoprotein and bile acid concentrations), glucose metabolism (glucose, insulin, HOMA index), non-cholesterol sterol and plasma inflammatory markers. | — |
Countries
Netherlands
Outcome results
None listed