Plant Stanols and Liver Inflammation in Overweight and Obese Children

NCT04783116 | Unknown DMC

• 1 other identifier: NL73527.000.20
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Keywords

Non-alcoholic Fatty Liver Disease; NAFLD; NASH; Non-alcoholic Steatohepatitis; Liver inflammation; Overweight; Obesity; Adolescents; Children; Lifestyle; Combined lifestyle intervention

Outcome Measures

Primary Outcomes (1)

• Change in plasma ALT concentration at 6 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 Outcomes (11)

• Change in plasma AST and plasma CK-18 concentration at 6 and 12 months.

  Baseline, 6 months and 12 months

• Change in liver inflammation parameters at 6 and 12 months.

  Baseline, 6 months and 12 months

• Change in lipid metabolism parameters at 6 and 12 months.

  Baseline, 6 months and 12 months

• Change in lipid protein metabolism parameters at 6 and 12 months.

  Baseline, 6 months and 12 months

• Change in plasma glucose concentration at 6 and 12 months.

  Baseline, 6 months and 12 months

Study Arms (2)

Plant stanols (3g/day)

EXPERIMENTAL

Consumption of plant stanol chews

Dietary Supplement: Plant stanols (3g/day)

Control

PLACEBO COMPARATOR

Consumption of placebo chews (without plant stanols)

Dietary Supplement: Placebo

Interventions

Plant stanols (3g/day) 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.

Also known as: Benecol (Raisio Nutrition Ltd., Raisio, Finland)

Plant stanols (3g/day)

Placebo 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.

Control

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Pediatric Obesity; Hepatitis; Overweight; Obesity

Interventions

plant stanol ester

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Anita CE Vreugdenhil, MD, PhD

CONTACT

0031433875284; a.vreugdenhil@mumc.nl

Judith W Lubrecht, MD

CONTACT

0031433875284; judith.lubrecht@mumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 5, 2021
• Study Start: March 15, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)