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Plant Sterols and Plant Stanols and Liver Inflammation

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ClinicalTrials.gov Identifier: NCT03627819
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : August 27, 2018
Sponsor:
Collaborators:
Unilever R&D
Raisio Group
BASF
Information provided by (Responsible Party):
Maastricht University Medical Center

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.


Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Dietary Supplement: Plant sterol-enriched margarine Dietary Supplement: Plant stanol-enriched margarine Dietary Supplement: Control margarine Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Triple (Participant, Investigator, Outcomes 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.
Primary Purpose: Treatment
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
Actual Study Start Date : May 4, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Active Comparator: Plant sterol-enriched margarine
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
Margarine enriched with plant sterol esters

Active Comparator: Plant stanol-enriched margarine
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
Margarine enriched with plant stanol esters

Placebo Comparator: Control margarine
Intake of 20 gram margarine without any addition, every day for 1 year
Dietary Supplement: Control margarine
Margarine without any addition




Primary Outcome Measures :
  1. Biopsy-proven liver inflammation [ Time Frame: 1 year intervention ]
    NASH histology


Secondary Outcome Measures :
  1. Hyperinsulinemic-euglycemic clamp [ Time Frame: 1 year intervention ]
    Insulin sensitivity

  2. Liver fat [ Time Frame: 1 year intervention ]
    Liver fat measured by magnetic resonance spectroscopy (MRS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Be able to give written informed consent
  2. 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.
  3. No presence of cirrhosis as diagnosed by the liver biopsy or by the FibroScan
  4. Aged between 18 and 75 years
  5. Body Mass Index (BMI) <40 kg/m2
  6. Willingness to consume 20 grams of margarine on a daily basis for a period of 12 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 investigators 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. Use of anti-coagulants
  7. History of illicit drug use
  8. Consume more than the recommended alcohol guidelines i.e. >21 alcohol units/week for males and >14 units/week for females
  9. 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)
  10. Use of an investigational product in another biomedical study within the previous month
  11. Contraindications for magnetic resonance imaging (MRI)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627819


Contacts
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Contact: Sabine Baumgartner, Dr. 043-3881305 sabine.baumgartner@maastrichtuniversity.nl

Locations
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Netherlands
Maastricht University Medical Centre Recruiting
Maastricht, Limburg, Netherlands, 6229 ER
Contact: Sabine Baumgartner, Dr.    +31 (0)43 3881305    sabine.baumgartner@maastrichtuniversity.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Unilever R&D
Raisio Group
BASF
Investigators
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Study Chair: Jogchum Plat, Prof. Maastricht University Medical Centre

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03627819     History of Changes
Other Study ID Numbers: NASH Pilot Study
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Maastricht University Medical Center:
Plant sterols
Plant stanols
Liver inflammation

Additional relevant MeSH terms:
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Inflammation
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Hepatitis
Pathologic Processes
Digestive System Diseases