NCT05037890

Brief Summary

This study is a randomized, placebo-controlled, double blinded pilot study to assess the effect of consuming plant sterol or plant stanol esters (3 grams/day) for 6 months on ALT concentrations in subjects with elevated ALT concentrations, i.e. who are at risk to develop NASH.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 8, 2021

Status Verified

August 1, 2021

Enrollment Period

2.9 years

First QC Date

August 31, 2021

Last Update Submit

August 31, 2021

Conditions

NASH - Nonalcoholic Steatohepatitis

Keywords

Liver inflammationPlant sterolsPlant stanols

Outcome Measures

Primary Outcomes (1)

  • Liver inflammation

    ALT levels

    6 months

Secondary Outcomes (1)

  • Glucose metabolism

    6 months

Study Arms (3)

Plant sterol enriched margarine

ACTIVE COMPARATOR

20 grams plant sterol enriched margarine on a daily basis for a period of 6 months.

Dietary Supplement: Margarine

Plant stanol enriched margarine

ACTIVE COMPARATOR

20 grams plant stanol enriched margarine on a daily basis for a period of 6 months.

Dietary Supplement: Margarine

Control margarine

PLACEBO COMPARATOR

20 grams control margarine on a daily basis for a period of 6 months.

Dietary Supplement: Margarine

Interventions

MargarineDIETARY_SUPPLEMENT

Intake of margarine

Control margarinePlant stanol enriched margarinePlant sterol enriched margarine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be able to give written informed consent
  • Elevated ALT concentrations (\>50 U/L for men and \>40 U/L for women)
  • Metabolic syndrome according to the NCEP ATP III definition (Grundy 2005)
  • Aged between 18 and 75 years
  • Willingness to consume 20 grams of margarine provided by us on a daily basis for a period of 6 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 investigator's 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, 6229 ER, Netherlands

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseHepatitis

Interventions

Margarine

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary FatsFatsLipidsDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Sabine Baumgartner, Dr

CONTACT

+31 433881305sabine.baumgartner@maastrichtuniversity.nl

Jogchum Plat, Prof

CONTACT

+31 433881309j.plat!@maastrichtuniversity.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Colour-coded margarin tubs
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized, placebo-controlled, double blinded study with a run-period of 2 weeks, an intervention period of 6 months and a wash-out period of 1 month.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 8, 2021

Study Start

February 20, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

September 8, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)