Soluble Fibre Supplementation in NAFLD
Recruiting · NCT05480696 · Interventional (participants receive a specific treatment) · Lead sponsor: McMaster University
View the official record on ClinicalTrials.gov →Interventions studied
Fructo-oligosaccharide enriched inulin supplementMaltodextrin
What this trial is about
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.
Who can take part
Age range
8 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- McMaster University Medical Center - Hamilton, Ontario, Canada