Plant Stanols and Liver Inflammation in Overweight and Obese Children

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

Interventions

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.

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.

Sponsors & Collaborators

• Maastricht University Medical Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-15

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• Netherlands

Study Locations