Non-Alcoholic Fatty Liver DiseaseNCT03627819
Plant Sterols and Plant Stanols and Liver Inflammation
A study testing Plant sterol-enriched margarine and Plant stanol-enriched margarine in people with Non-Alcoholic Fatty Liver Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Plant sterol-enriched margarine and Plant stanol-enriched margarine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 May 2018to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Centre
Maastricht, Limburg, 6229 ER
Sabine Baumgartner, Dr., +31 (0)43 3881305, sabine.baumgartner@maastrichtuniversity.nl
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Plant sterol-enriched margarine, Plant stanol-enriched margarine, Control margarine
- Keywords
- Plant sterols, Plant stanols, Liver inflammation
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant sterol-enriched margarineDietary supplement
Margarine enriched with plant sterol esters
Plant stanol-enriched margarineDietary supplement
Margarine enriched with plant stanol esters
Control margarineDietary supplement
Margarine without any addition
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Plant stanol-enriched margarine |
| Control margarine | Placebo comparator | Intake of 20 gram margarine without any addition, every day for 1 year Receives: Dietary Supplement: Control margarine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biopsy-proven liver inflammation
NASH histology
Measured: 1 year intervention
Secondary outcomes (2)
Hyperinsulinemic-euglycemic clamp
Insulin sensitivity
Measured: 1 year intervention
Liver fat
Liver fat measured by magnetic resonance spectroscopy (MRS)
Measured: 1 year intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start4 May 2018
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever R&D, Raisio Group, BASF
- Responsible party
- Sponsor
- Investigators
- Jogchum Plat, Prof., Study chair, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627819
- Sponsor's protocol ID
- NASH Pilot Study
- Status last verified
- Aug 2018
- First submitted
- 18 Jul 2018
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03627819
- Acronym / sponsor ID
- NASH Pilot Study
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- Plant sterols, Plant stanols, Liver inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Unilever R&D, Raisio Group, BASF
- Study start
- 4 May 2018 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Plant sterol-enriched margarine | Active comparator | Dietary Supplement: Plant sterol-enriched margarineIntake of 20 gram margarine with added plant sterol esters, providing 3 gram plant sterols per day for 1 year |
| Plant stanol-enriched margarine | Active comparator | Dietary Supplement: Plant stanol-enriched margarineIntake of 20 gram margarine with added plant stanol esters, 3 gram plant stanols per day for 1 year |
| Control margarine | Placebo comparator | Dietary Supplement: Control margarineIntake of 20 gram margarine without any addition, every day for 1 year |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant sterol-enriched margarineMargarine enriched with plant sterol esters | Dietary supplement | Plant sterol-enriched margarine |
| Plant stanol-enriched margarineMargarine enriched with plant stanol esters | Dietary supplement | Plant stanol-enriched margarine |
| Control margarineMargarine without any addition | Dietary supplement | Control margarine |
Primary outcome
Biopsy-proven liver inflammation
Time frame: 1 year intervention
NASH histology
2 secondary outcomes
Hyperinsulinemic-euglycemic clamp
Time frame: 1 year intervention
Liver fat
Time frame: 1 year intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jogchum Plat, Prof. study chair
Maastricht University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant sterol-enriched margarine and Plant stanol-enriched margarine in people with Non-Alcoholic Fatty Liver Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabine Baumgartner, Dr. (043-3881305, sabine.baumgartner@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biopsy-proven liver inflammation (time frame: 1 year intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.