The effects of plant sterol and plant stanol ester enriched foods on liver inflammation in subjects at risk to develop NASH

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

1. Be able to give written informed consent
2. Metabolic syndrome according to the NCEP ATP III definition (Grundy 2005)
3. Aged between 18 and 75 years
4. Willingness to consume 20 grams of margarine provided by us on a daily basis
for a period of 6 months

Exclusion Criteria

1. Are less than 18 years of age or over 75 years of age
2. Females who are pregnant, breast feeding or who may wish to become pregnant
during the study
3. Have 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 investigator*s judgement, entry to the study
4. Severe medical conditions that might interfere with the study such as
epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel
disease and rheumatoid arthritis
5. Use of diuretics or insulin therapy
6. History of illicit drug use
7. Consume more than the recommended alcohol guidelines i.e. >21 alcohol
units/week for males and >14 units/week for females
8. Not willing to stop the consumption of plant sterol or plant stanol enriched
products 1 month before the start of the study (wash-in period)
9. Use of an investigational product in another biomedical study within the
previous month

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>• liver function (AST, GGT, bilirubin CK18) and non-invasive plasma markers of<br /><br>liver inflammation (cathepsin-D and acid phosphatase)<br /><br>• liver inflammation assessed by non-invasive volatile organic compounds (VOCs)<br /><br>• liver fibroses assessed by the FibroScan<br /><br>• body composition assessed by the BodPod<br /><br>• microvascular function assessed by retinal images<br /><br>• lipid and lipoprotein metabolism (cholesterol, triacylglycerol,<br /><br>(apo)lipoprotein and bile acid concentrations), glucose metabolism (glucose,<br /><br>insulin, HOMA index), non-cholesterol concentrations and plasma inflammatory<br /><br>markers<br /><br><br /><br>In a subgroup (n=30):<br /><br>• liver inflammation and liver fat assessed by additional non-invasive magnetic<br /><br>resonance spectroscopy (MRS)</p><br>