Plant Sterols and Plant Stanols and Liver Inflammation

NCT03627819 | Unknown

• 1 other identifier: NASH Pilot Study
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Plant sterols; Plant stanols; Liver inflammation

Outcome Measures

Primary Outcomes (1)

• Biopsy-proven liver inflammation

  NASH histology

  1 year intervention

Secondary Outcomes (2)

• Hyperinsulinemic-euglycemic clamp

  1 year intervention

• Liver fat

  1 year intervention

Study Arms (3)

Plant sterol-enriched margarine

ACTIVE COMPARATOR

Intake of 20 gram margarine with added plant sterol esters, providing 3 gram plant sterols per day for 1 year

Dietary Supplement: Plant sterol-enriched margarine

Plant stanol-enriched margarine

ACTIVE COMPARATOR

Intake of 20 gram margarine with added plant stanol esters, 3 gram plant stanols per day for 1 year

Dietary Supplement: Plant stanol-enriched margarine

Control margarine

PLACEBO COMPARATOR

Intake of 20 gram margarine without any addition, every day for 1 year

Dietary Supplement: Control margarine

Interventions

Plant sterol-enriched margarine DIETARY_SUPPLEMENT

Margarine enriched with plant sterol esters

Plant sterol-enriched margarine

Plant stanol-enriched margarine DIETARY_SUPPLEMENT

Margarine enriched with plant stanol esters

Plant stanol-enriched margarine

Control margarine DIETARY_SUPPLEMENT

Margarine without any addition

Control margarine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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 12 months

You may not qualify if:

• 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 the study
• 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 investigators 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 and rheumatoid 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 for males 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 previous month
• Contraindications for magnetic resonance imaging (MRI)

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Unilever R&D: collaborator
• Raisio Group: collaborator
• BASF: collaborator

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, 6229 ER, Netherlands

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Hepatitis

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Jogchum Plat, Prof.

  Maastricht University Medical Centre

  STUDY CHAIR

Central Study Contacts

Sabine Baumgartner, Dr.

CONTACT

043-3881305; sabine.baumgartner@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The margarine is provided in white but colour-coded tubs and it is not known to the participant and the researcher which colour coded margarine is placebo, plant sterol or stanol ester margarine.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 13, 2018
• Study Start: May 4, 2018
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 27, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)