Non-Alcoholic Fatty Liver Disease Clinical Trial
— FINDOfficial title:
The Efficacy of Soluble Fibre Supplementation for the Treatment of Pediatric Non-alcoholic Fatty Liver Disease (NAFLD)
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | March 2027 |
Est. primary completion date | March 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | McMaster University Medical Center | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes in molecular profiling of gut microbiome | Profiling of the gut microbiome will be measured from collected stool samples | Six months | |
Primary | Change in hepatic fat content. | Hepatic fat content will be measured via MRI at baseline and 6-months using standard techniques, optimized for accuracy, precision and reproducibility of proton density fat fraction (PDFF) quantification. | Six months | |
Secondary | Change in hepatic stiffness. | Hepatic stiffness, a measure of hepatic fibrosis, will be measured via MRI using standard techniques. | Six months | |
Secondary | Change in glycemic control, or insulin resistance. | Measured using plasma glucose (fasting and + 2 hours following oral glucose load) and HbA1c from a 2-hour OGTT (1.75g/kg, up to maximum of 75g glucose administered). | Six months | |
Secondary | Change in liver enzymes (ALT, AST, GGT, or ALP) | Liver enzymes will be measured using Abbott ARCHITECT Systems | Six months | |
Secondary | Change in body fat percentage | Body fat will be measured using a DXA scanner, by research team members previously trained in DXA measurement. | Six months | |
Secondary | Change in weight | Weight will be measured using an electronic platform scale. | Six months | |
Secondary | Change in height | Height will be measured using a wall mounted stadiometer. | Six months | |
Secondary | Change in BMI | BMI will be calculated mathematically from other outcomes such as height and weight. | Six months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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