Soluble Fibre Supplementation in NAFLD

Sponsor
McMaster University
Study ID
NCT05480696
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Hepatic Steatosis
  • Non Alcoholic Steatohepatitis
  • Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

Sex
ALL
Age
8 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Fructo-oligosaccharide enriched inulin supplement — DIETARY_SUPPLEMENT
    Experiment
  • Maltodextrin — OTHER
    Placebo.

Study Details

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.

Key Dates

First listed
Jul 29, 2022
Start date
Sep 9, 2022
Status verified
Nov 2024
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Change in hepatic fat content. [ Time Frame: Six months ]

Central Contacts

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