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RECRUITINGPhase 2INTERVENTIONAL

Soluble Fibre Supplementation in NAFLD

The Efficacy of Soluble Fibre Supplementation for the Treatment of Pediatric Non-alcoholic Fatty Liver Disease (NAFLD)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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). Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIETARY_SUPPLEMENT

Fructo-oligosaccharide enriched inulin supplement

Experiment

OTHER

Maltodextrin

Placebo.

Locations (1)

McMaster University Medical Center
Hamilton, Ontario, Canada