Soluble Fibre Supplementation in NAFLD

ConditionsNon-Alcoholic Fatty Liver Disease Non Alcoholic Steatohepatitis Hepatic Steatosis

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age8-17

SponsorMcMaster University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

Fructo-oligosaccharide enriched inulin supplement
Dietary supplement
Experiment
Maltodextrin
Other intervention
Placebo.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Oligofructose Inulin SupplementationExperimental treatment 1 intervention

Group B: Maltodextrin SupplementationSham comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Six months

Secondary outcomes

Change in hepatic stiffness.

Hepatic stiffness, a measure of hepatic fibrosis, will be measured via MRI using standard techniques.

Time frame

Six months

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).

Time frame

Six months

Change in liver enzymes (ALT, AST, GGT, or ALP)

Liver enzymes will be measured using Abbott ARCHITECT Systems

Time frame

Six months

Change in body fat percentage

Body fat will be measured using a DXA scanner, by research team members previously trained in DXA measurement.

Time frame

Six months

Other outcomes

Changes in molecular profiling of gut microbiome

Profiling of the gut microbiome will be measured from collected stool samples

Time frame

Six months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

McMaster University

Lead sponsor

Source ClinicalTrials.gov

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