The effects of plant stanol ester supplements on liver inflammation in children with overweight or obesity

Withdrawn

Conditions: leverontsteking
fatty liver
Liver inflammation

Registration Number: NL-OMON50018

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 52

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

- Have a severe medical conditions which contraindicates, in the investigators
judgement, entry to the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome parameter in this study is the change in plasma ALT<br /><br>concentration.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary study parameters:<br /><br>- Effect of plant stanol ester consumption on liver function (AST, GGT,<br /><br>bilirubin CK18) and non-invasive plasma markers of liver inflammation<br /><br>(cathepsin-D and acid phosphatase)<br /><br>- Effect of plant stanol ester consumption on degree of liver steatosis,<br /><br>assessed with HRI measurement during abdominal ultrasonography;<br /><br>- Effect of plant stanol ester consumption on degree of liver fibrosis,<br /><br>assessed with transient elastography, using a FibroScan;<br /><br>- Effect of plant stanol ester consumption on lipid and lipoprotein metabolism<br /><br>(cholesterol, triacylglycerol, (apo)lipoprotein and bile acid concentrations),<br /><br>glucose metabolism (glucose, insulin, HOMA index), non-cholesterol sterol and<br /><br>plasma inflammatory markers.<br /><br></p><br>