Status:
UNKNOWN
Plant Stanols and Liver Inflammation in Overweight and Obese Children
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Non-Alcoholic Fatty Liver Disease
Non-alcoholic Steatohepatitis
Eligibility:
All Genders
4-18 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04783116
Start Date
March 15 2021
End Date
December 31 2022
Last Update
March 5 2021
Active Locations (1)
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1
Maastricht University Medical Center
Maastricht, Netherlands