RECRUITINGPhase 2INTERVENTIONAL
Soluble Fibre Supplementation in NAFLD
The Efficacy of Soluble Fibre Supplementation for the Treatment of Pediatric Non-alcoholic Fatty Liver Disease (NAFLD)
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