Soluble Fibre Supplementation in NAFLD
Non-alcoholic Fatty Liver Disease | Hepatic Steatosis | Non Alcoholic SteatohepatitisThe 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.
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Participation Requirements
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Sex:
ALL -
Eligible Ages:
8 to 17
Participation Criteria
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
Study Location
McMaster University Medical Center
McMaster University Medical CenterHamilton, Ontario
Canada
Contact Study Team
- Study Sponsored By
- McMaster University
- Participants Required
- More Information
- Study ID:
NCT05480696