Plant Stanols and Liver Inflammation in Overweight and Obese Children

NCT ID: NCT04783116

Last Updated: 2021-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2022-12-31

Brief Summary

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.

Conditions

Non-Alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; NAFLD; NASH; NASH - Nonalcoholic Steatohepatitis; Childhood Obesity; Childhood Overweight; Pediatric Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Plant stanols (3g/day)

Consumption of plant stanol chews

Group Type: EXPERIMENTAL

Plant stanols (3g/day)

Intervention Type: DIETARY_SUPPLEMENT

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.

Control

Consumption of placebo chews (without plant stanols)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Benecol (Raisio Nutrition Ltd., Raisio, Finland)

Eligibility Criteria

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).

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Maastricht University Medical Center

Maastricht, , Netherlands

Countries

Netherlands

Central Contacts

Anita CE Vreugdenhil, MD, PhD

Role: CONTACT

a.vreugdenhil@mumc.nl

0031433875284

Judith W Lubrecht, MD

Role: CONTACT

judith.lubrecht@mumc.nl

0031433875284

Facility Contacts

Anita CE Vreugdenhil, MD, PhD

Role: primary

a.vreugdenhil@mumc.nl

0031433875284

Judith W Lubrecht, MD

Role: backup

judith.lubrecht@mumc.nl

0031433875284

Other Identifiers

NL73527.000.20

Identifier Type: -

Identifier Source: org_study_id