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Plant Sterols and Plant Stanols and Liver Inflammation

Primary Purpose

Non-Alcoholic Fatty Liver Disease

Status

Unknown status

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Plant sterol-enriched margarine

Plant stanol-enriched margarine

Control margarine

About this trial

This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring Plant sterols, Plant stanols, Liver inflammation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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
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

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 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)

Sites / Locations

Maastricht University Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Plant sterol-enriched margarine

Plant stanol-enriched margarine

Control margarine

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Biopsy-proven liver inflammation

NASH histology

Secondary Outcome Measures

Hyperinsulinemic-euglycemic clamp

Insulin sensitivity

Liver fat

Liver fat measured by magnetic resonance spectroscopy (MRS)

Full Information

NCT ID

NCT03627819

First Posted

July 18, 2018

Last Updated

August 23, 2018

Sponsor

Maastricht University Medical Center

Collaborators

Unilever R&D, Raisio Group, BASF

1. Study Identification

Unique Protocol Identification Number

NCT03627819

Brief Title

Plant Sterols and Plant Stanols and Liver Inflammation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 4, 2018 (Actual)

Primary Completion Date

October 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maastricht University Medical Center

Collaborators

Unilever R&D, Raisio Group, BASF

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Alcoholic Fatty Liver Disease

Keywords

Plant sterols, Plant stanols, Liver inflammation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Plant sterol-enriched margarine

Arm Type

Active Comparator

Arm Description

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

Arm Title

Plant stanol-enriched margarine

Arm Type

Active Comparator

Arm Description

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

Arm Title

Control margarine

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Plant sterol-enriched margarine

Intervention Description

Margarine enriched with plant sterol esters

Intervention Type

Dietary Supplement

Intervention Name(s)

Plant stanol-enriched margarine

Intervention Description

Margarine enriched with plant stanol esters

Intervention Type

Dietary Supplement

Intervention Name(s)

Control margarine

Intervention Description

Margarine without any addition

Primary Outcome Measure Information:

Title

Biopsy-proven liver inflammation

Description

NASH histology

Time Frame

1 year intervention

Secondary Outcome Measure Information:

Title

Hyperinsulinemic-euglycemic clamp

Description

Insulin sensitivity

Time Frame

1 year intervention

Title

Liver fat

Description

Liver fat measured by magnetic resonance spectroscopy (MRS)

Time Frame

1 year intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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 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 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sabine Baumgartner, Dr.

Phone

043-3881305

sabine.baumgartner@maastrichtuniversity.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jogchum Plat, Prof.

Organizational Affiliation

Maastricht University Medical Centre

Official's Role

Study Chair

Facility Information:

Facility Name

Maastricht University Medical Centre

City

Maastricht

State/Province

Limburg

ZIP/Postal Code

6229 ER

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sabine Baumgartner, Dr.

Phone

+31 (0)43 3881305

sabine.baumgartner@maastrichtuniversity.nl

12. IPD Sharing Statement

Plan to Share IPD

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Plant Sterols and Plant Stanols and Liver Inflammation

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