Tests a mixed fibre supplement for fatty liver disease in children
Tests a fibre supplement in children with fatty liver disease, compared with maltodextrin.
Plain-language title generated from the registry record
Registry title: Soluble Fibre Supplementation in NAFLD
Key facts
- Where
- Hamilton, CanadaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 8 and 17 years old?
Source: NCT05480696, who can take part
Where in Canada
- McMaster University Medical CenterHamilton, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- McMaster University
- Trial code
- NCT05480696
- Record updated
- 12 November 2024
- Original description
The FIND study will look at the effect of a nutritional mixed fibre supplement, oligofructose and inulin (OF+INU), on children with non-alcoholic fatty liver disease. In this randomized, double- blind controlled trial, subjects will be given a supplement, in the form of oral pills, and will have bloodwork performed, their diets analyzed, and liver fat measured at several timepoints. Liver fat will be measured by using a specialized MRI device located at St. Joseph's Hospital. Subjects will be recruited from the Children's Exercise and Nutrition Clinic.Read full original descriptionShow less
The Efficacy of Soluble Fibre Supplementation for the Treatment of Pediatric Non-alcoholic Fatty Liver Disease (NAFLD)
The FIND study will look at the effect of a nutritional mixed fibre supplement, oligofructose and inulin (OF+INU), on children with non-alcoholic fatty liver disease. In this randomized, double- blind controlled trial, subjects will be given a supplement, in the form of oral pills, and will have bloodwork performed, their diets analyzed, and liver fat measured at several timepoints. Liver fat will be measured by using a specialized MRI device located at St. Joseph's Hospital. Subjects will be recruited from the Children's Exercise and Nutrition Clinic.
Inclusion: Children ages 8-17 years; Diagnosed with obesity (BMI ≥2 standard deviations above WHO reference median); Enrolled in GHWM Clinic; Clinical evidence of NAFLD (elevation of ALT, greater than 2x upper-limit-of-normal (ULN) [ALT>80 IU/L for 8-17 years of age], and hepatic steatosis measured as part of clinic enrolment).
Exclusion: Contraindications to having MRI (claustrophobia, metal implant, recent tattoo, weight > 300lbs); Concomitant use of other fibre supplements; Type 1, Type 2 diabetes mellitus (T1DM, T2DM); Presence of another known cause of liver disease; Known allergy or hypersensitivity to OF-INU supplementation; Medications known to affect hepatic fat content, taken within the past year (i.e., glucocorticoids, anabolic steroids, tetracycline, anticonvulsants, antipsychotics, glucose- lowering medications); Self-reported alcohol intake >7 drinks/week or 3 drinks/day.