The effects of plant sterol and plant stanol ester enriched foods on biopsy proven liver inflammation in NAFLD patients - a proof-of-concept pilot study

Recruiting

Conditions: everontsteking
fatty liver
Liver inflammation

Registration Number: NL-OMON55602

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

- be able to give written informed consent
- diagnosed with liver inflammation by a liver biopsy <12 months prior to start
of the study. All patients with biopsies older than 2 months must have a stable
weight and biochemical liver test results. A certified, experienced pathologist
will assess the presence of liver inflammation.
- no presence of cirrhosis as diagnosed by the liver biopsy or by the FibroScan
- age between 18 and 75 years
- Body Mass Index (BMI) <40 kg/m2
- willingness to consume 20 grams of margarine on a daily basis for a period of
12 months

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome parameter in this study is biopsy proven liver<br /><br>inflammation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- liver inflammation via plasma markers<br /><br>- liver inflammation via MRS<br /><br>- liver inflammation via volatile organic compounds<br /><br>- liver fat via MRS<br /><br>- liver fibrosis via de FibroScan<br /><br>- insulin sensitivity via a hyperinsulinemic-euglycemic clamp<br /><br>- lipid metabolism<br /><br>- glucose metabolism</p><br>