Health Trials

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Fructo-oligosaccharide enriched inulin supplement
  • Maltodextrin

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

1
McMaster University Medical CenterL8S4K1, HamiltonOntario, Canada

Sponsors and collaborators

McMaster University

Lead sponsor

Source ClinicalTrials.gov