Soluble Fibre Supplementation in NAFLD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age8-17
SponsorMcMaster University
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 groupsSponsors and collaborators
Source ClinicalTrials.gov