The Efficacy of Soluble Fibre Supplementation for the Treatment of Pediatric Non-alcoholic Fatty Liver Disease (NAFLD)

Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 17
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Canada
McMaster University Medical Center
RECRUITING
Hamilton
Contact Information
Primary
Paige AL Cheveldayoff, BSC
cheveldp@mcmaster.ca
3063611281
Backup
Nikhil Pai, MD
pain@mcmaster.ca
2892082457
Time Frame
Start Date: 2022-09-09
Estimated Completion Date: 2027-03
Participants
Target number of participants: 60
Treatments
Experimental: Oligofructose Inulin Supplementation
The intervention group will receive a daily fibre supplementation of (fructo-oligosaccharide enriched inulin, 4g twice daily; Orafti®Synergy1, BENEO), a tasteless white powder contained within a tear-able, partitioned 4g sachet, sprinkled and dissolved in 125 mL of water.
Sham_comparator: Maltodextrin Supplementation
The control group will receive a daily supplementation of carbohydrate placebo (isocaloric maltodextrin), identical in colour, packaging, preparation, and dose (4g, twice daily; C\*Dry MD™,Cargill).
Related Therapeutic Areas
Sponsors
Leads: McMaster University

This content was sourced from clinicaltrials.gov