Ireland
--:--IST
Latest
Clinical Trials in Canada / NCT05480696
Recruiting Phase 2

Soluble Fibre Supplementation in NAFLD

NCT05480696 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2022-09-09
Last updated
2024-11-12

Condition(s) studied

Non-Alcoholic Fatty Liver DiseaseNon Alcoholic SteatohepatitisHepatic Steatosis

Investigational drug(s) / intervention(s)

Fructo-oligosaccharide enriched inulin supplementMaltodextrin

Fructo-oligosaccharide enriched inulin supplement: Experiment

Maltodextrin: Placebo.

Study summary

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.

Eligibility

Sex
ALL
Min age
8 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * Type 1, Type 2 diabetes mellitus (T1DM, T2DM) * Contraindications to having MRI (claustrophobia, metal implant, recent tattoo, weight \> 300lbs) * Concomitant use of other fibre supplements * Medications known to affect hepatic fat content, taken within the past year (i.e., glucocorticoids, anabolic steroids, tetracycline, anticonvulsants, antipsychotics, glucose- lowering medications) * Presence of another known cause of liver disease * Known allergy or hypersensitivity to OF-INU supplementation * Self-reported alcohol intake \>7 drinks/week or 3 drinks/day

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
McMaster University Medical Center Hamilton Ontario Recruiting

More McMaster University trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05480696 on ClinicalTrials.gov ↗ ← All trials in Canada