Plant Stanols and Liver Inflammation in Overweight and Obese Children

Maastricht University Medical Centre (MUMC)

Status: Unknown

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

Treatments: Dietary Supplement: Plant stanols (3g/day); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04783116

NL73527.000.20

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

Plant stanols (3g/day)

Experimental group

Description:

Consumption of plant stanol chews

Treatment:

Dietary Supplement: Plant stanols (3g/day)

Control

Placebo Comparator group

Description:

Consumption of placebo chews (without plant stanols)

Treatment:

Dietary Supplement: Placebo