Clinical trial NCT04783116: Plant Stanols and Liver Inflammation in Overweight and Obese Children
Official title: The Effects of Plant Stanol Ester Supplements on Liver Inflammation in Overweight and Obese Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Non-alcoholic Steatohepatitis
NAFLD
NASH
NASH - Nonalcoholic Steatohepatitis
Childhood Obesity
Childhood Overweight
Pediatric Obesity
Keywords: Non-alcoholic Fatty Liver Disease
NAFLD
NASH
Non-alcoholic Steatohepatitis
Liver inflammation
Overweight
Obesity
Adolescents
Children
Lifestyle
Combined lifestyle intervention
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 52
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Change in plasma ALT concentration at 6 and 12 months.
timeFrame: Baseline, 6 months and 12 months
Secondary outcomes:
measure: Change in plasma AST and plasma CK-18 concentration at 6 and 12 months.
timeFrame: Baseline, 6 months and 12 months
measure: Change in liver inflammation parameters at 6 and 12 months.
timeFrame: Baseline, 6 months and 12 months
measure: Change in lipid metabolism parameters at 6 and 12 months.
timeFrame: Baseline, 6 months and 12 months
measure: Change in lipid protein metabolism parameters at 6 and 12 months.
timeFrame: Baseline, 6 months and 12 months
measure: Change in plasma glucose concentration at 6 and 12 months.
timeFrame: Baseline, 6 months and 12 months
measure: Change in plasma insulin concentration at 6 and 12 months.
timeFrame: Baseline, 6 months and 12 months
measure: Change in insulin sensitivity at 6 and 12 months.
timeFrame: Baseline, 6 months and 12 months
measure: Change in non-cholesterol sterol and oxy(phyto)sterol concentrations at 6 and 12 months.
timeFrame: Baseline, 6 months and 12 months
measure: Change in plasma inflammatory markers at 6 and 12 months.
timeFrame: Baseline, 6 months and 12 months
measure: Change in ultrasonographic hepatorenal index (HRI) at 6 and 12 months.
timeFrame: Baseline, 6 months and 12 months
measure: Change in continuous Controlled Attenuation Parameter (CAP) at 6 and 12 months.
timeFrame: Baseline, 6 months and 12 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
References: