Plant Stanols and Liver Inflammation in Overweight and Obese Children

March 2, 2021 updated by: Maastricht University Medical Center

The Effects of Plant Stanol Ester Supplements on Liver Inflammation in Overweight and Obese Children

Obesity is associated with a variety of co-morbidities. Children with obesity are more likely to have risk factors associated with cardiovascular diseases (CVD) and CVD risk markers (e.g. hypertension, elevated serum cholesterol, and type 2 diabetes mellitus), but also with organ specific pathologies such as a non-alcoholic fatty liver disease (NAFLD). A recent meta-analysis has shown that the prevalence of NAFLD in obese pediatric populations is approximately 35%, compared to approximately 8% in general pediatric population, making it a very important health threat in these populations. Successful pharmacological interventions to treat or prevent NASH are not yet available and so far only weight loss has clear benefits. However, it is well known that sustained weight-loss is difficult to achieve on the longer-term. The investigators recently demonstrated in mice that plant sterol and stanol ester consumption inhibited the development of liver inflammation. Moreover, Javanmardi et al. recently demonstrated in a population of adult NAFLD patients, that plasma concentrations of Alanine Transaminase (ALT) were reduced after daily plant sterol consumption (1.6 g/d) for 6 weeks. In this study, the investigators propose to evaluate the effect of consuming soft chews enriched with plant stanol esters (3 grams/day) on ALT concentrations in children with overweight or (morbid) obesity who are at risk of developing NAFLD, in a randomized, placebo-controlled, double blinded study with an intervention period and follow-up period of 6 months. 52 overweight and obese children with elevated ALT concentrations (>39 U/L for boys and >33 U/L for girls) will be included. All children will be randomly allocated to consume control or plant stanol ester enriched soft chews on a daily basis for a period of 6 months. After 12 months there will be an additional blood sample to evaluate whether the 6 months intervention is still effective.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University Medical Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Judith W Lubrecht, MD
        • Sub-Investigator:
          • Sabine Baumgartner, PhD
        • Sub-Investigator:
          • Johanna Kreutz, MD
        • Principal Investigator:
          • Anita CE Vreugdenhil, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participation in lifestyle intervention, provided by the Centre for Overweight Adolescent and Children Healthcare (COACH), at the Department of Pediatrics at the Maastricht University Medical Center (MUMC+).
  • Age between 4-18 years old
  • Plasma ALT concentrations above 39 U/L for boys and above 33 U/L for girls.
  • Willingness to consume 6 soft chews on a daily basis, for a period of 6 months.

Exclusion Criteria:

  • Presence of a severe medical condition, which contraindicates, in the investigators judgement, entry to the study.
  • No signed informed consent by relevant parties (parents of children aged below 12 years, parents and or children aged between 12 and 16 years, or children aged 16 years and older).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Plant stanols (3g/day)
Consumption of plant stanol chews
Dietary supplement: Plant stanols (3g/day)
Oral consumption of 6 plant stanol enriched chews per day for 6 months (total dosage is 3g/day). Chews are consumed with main meals: two with breakfast, two with lunch and two with dinner.
Other Names:
  • Benecol (Raisio Nutrition Ltd., Raisio, Finland)
Placebo Comparator: Control
Consumption of placebo chews (without plant stanols)
Dietary supplement: Placebo
Oral consumption of 6 placebo chews per day for 6 months. Chews are consumed with main meals: two with breakfast, two with lunch and two with dinner.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in plasma ALT concentration at 6 and 12 months.
Time Frame: Baseline, 6 months and 12 months
Plasma ALT (Alanine Aminotransferase) concentration is a laboratory parameter, measured in blood, reflecting possible presence of NAFLD. Concentrations below 26 U/L for boys, and below 22 U/L for girls, are considered normal. Concentrations above 39 U/L for boys, and above 33 U/L are considered to reflect presence of NAFLD.
Baseline, 6 months and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in plasma AST and plasma CK-18 concentration at 6 and 12 months.
Time Frame: Baseline, 6 months and 12 months
Aspartate Aminotransferase (AST) and cytokeratin-18 (CK-18) are laboratory parameters, measured in the participants blood in U/L, reflecting liver health.
Baseline, 6 months and 12 months
Change in liver inflammation parameters at 6 and 12 months.
Time Frame: Baseline, 6 months and 12 months
Cathepsin-D and acid phosphatase are laboratory parameters, measured in mg/L in the participants blood, reflecting liver inflammation.
Baseline, 6 months and 12 months
Change in lipid metabolism parameters at 6 and 12 months.
Time Frame: Baseline, 6 months and 12 months
Serum total cholesterol, HDL cholesterol, triacylglycerol (TAG) with correction for free glycerol and non-esterified fatty acids (NEFA) are laboratory parameters, measured in mmol/L in the participants blood, reflecting their lipid metabolism.
Baseline, 6 months and 12 months
Change in lipid protein metabolism parameters at 6 and 12 months.
Time Frame: Baseline, 6 months and 12 months
ApoA1 and apoB100 plasma concentrations are laboratory parameters, measured in g/L in the participants blood, reflective of the lipoprotein metabolism.
Baseline, 6 months and 12 months
Change in plasma glucose concentration at 6 and 12 months.
Time Frame: Baseline, 6 months and 12 months
Fasting glucose is a laboratory parameter, measured in mmol/L in the participants blood, reflecting glucose metabolism.
Baseline, 6 months and 12 months
Change in plasma insulin concentration at 6 and 12 months.
Time Frame: Baseline, 6 months and 12 months
Fasting insulin concentrations is a laboratory parameters, measured in mU/L in the participants blood, reflecting glucose metabolism.
Baseline, 6 months and 12 months
Change in insulin sensitivity at 6 and 12 months.
Time Frame: Baseline, 6 months and 12 months
Insulin sensitivity will be calculated using the HOMA-IR formula (homeostatis model) which is (fasting glucose*fasting insulin) /22,5. As HOMA-IR is a ratio, it does not have a unit.
Baseline, 6 months and 12 months
Change in non-cholesterol sterol and oxy(phyto)sterol concentrations at 6 and 12 months.
Time Frame: Baseline, 6 months and 12 months
A panel of non-cholesterol sterols, as surrogate markers for cholesterol absorption and synthesis will be measured in the participants blood.
Baseline, 6 months and 12 months
Change in plasma inflammatory markers at 6 and 12 months.
Time Frame: Baseline, 6 months and 12 months
Plasma concentrations of CRP and high sensitivity CRP will be measured in mg/L in the participants blood, to assess presence of low-grade inflammation in the body.
Baseline, 6 months and 12 months
Change in ultrasonographic hepatorenal index (HRI) at 6 and 12 months.
Time Frame: Baseline, 6 months and 12 months
HRI is measured during a conventional ultrasound of the liver, in which three close-up images of the liver and right kidney are made by a physician-researcher. HRI is calculated from these images by a pediatric radiologist, as the ratio of the hepatic brightness and the renal brightness (HRI = echogenicity of the liver/echogenicity of the kidney). The average of the three images is taken as the definite HRI, as a reflection of hepatic fat content.
Baseline, 6 months and 12 months
Change in continuous Controlled Attenuation Parameter (CAP) at 6 and 12 months.
Time Frame: Baseline, 6 months and 12 months
CAP is measured during a vibration controlled transient elastography of the liver, which is performed with a Fibroscan by a physician-researcher. The value is a reflection of hepatic fat content.
Baseline, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL73527.000.20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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