Plant Sterols and Plant Stanols and Liver Inflammation

Phase

N/A

Condition

Inflammation

Hepatitis

Liver Disease

Treatment

N/A

Clinical Study ID

NCT03627819

NASH Pilot Study

Ages 18-75
All Genders
Accepts Healthy Volunteers

Study Summary

As the prevalence of obesity is reaching epidemic proportions, the prevalence of non-alcoholic fatty liver disease (NAFLD), including non-alcoholic steatohepatitis (NASH), increases concomitantly and becomes a major global health hazard. Successful pharmacological interventions to treat or prevent NASH are not available and so far only weight loss has clear benefits, but sustained weight-loss is difficult to achieve on the longer-term. We recently demonstrated in mice that plant sterol and stanol ester consumption inhibited the development of liver inflammation, which needs to be validated in humans in a translational approach. In the current proposed pilot study, the effect of consuming plant sterol or plant stanol esters on biopsy proven liver inflammation will be investigated in NAFLD patients.

The objective is to assess the effect of consuming plant sterol or plant stanol esters (3 grams/day) for 12 months on biopsy proven liver inflammation in NAFLD patients.

This study is a randomized, placebo-controlled, double blinded pilot study with a run-period of 2 weeks, an intervention period of 12 months and a wash-out period of 1 month.

The study population consists of 15 patients with biopsy-proven liver inflammation, aged 18-75 years.

All subjects will start a run-in period of two weeks during which they consume daily 20 grams of control margarine after which they will be randomly allocated to consume 20 grams control margarine or plant sterol or plant stanol enriched margarine on a daily basis for a period of 12 months. The primary outcome parameter in this study is biopsy proven liver inflammation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Be able to give written informed consent
Diagnosed with liver inflammation by a liver biopsy <12 months prior to start of thestudy. All patients with biopsies older than 2 months must have a stable weight andbiochemical liver test results. A certified, experienced pathologist will assess thepresence of liver inflammation.
No presence of cirrhosis as diagnosed by the liver biopsy or by the FibroScan
Aged 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 12months

Exclusion

Exclusion Criteria:

Are less than 18 years of age or over 75 years of age
Females who are pregnant, breast feeding or who may wish to become pregnant during thestudy
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 theinvestigators judgement, entry to the study
Severe medical conditions that might interfere with the study such as epilepsy,asthma, chronic obstructive pulmonary disease, inflammatory bowel disease andrheumatoid arthritis
Use of diuretics or insulin therapy
Use of anti-coagulants
History of illicit drug use
Consume more than the recommended alcohol guidelines i.e. >21 alcohol units/week formales and >14 units/week for females
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)
Use of an investigational product in another biomedical study within the previousmonth
Contraindications for magnetic resonance imaging (MRI)

Study Design

May 04, 2018

December 31, 2019

Study Description