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Soluble Fibre Supplementation in NAFLD

RECRUITINGPhase 2Sponsored by McMaster University
Actively Recruiting
PhasePhase 2
SponsorMcMaster University
Started2022-09-09
Est. completion2027-03
Eligibility
Age8 Years – 17 Years
Healthy vol.Accepted

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

Age: 8 Years – 17 YearsHealthy volunteers accepted
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

Conditions4

Hepatic SteatosisLiver DiseaseNon Alcoholic Fatty Liver DiseaseNon-Alcoholic Steatohepatitis

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