Clinical trial NCT05480696: Soluble Fibre Supplementation in NAFLD
Official title: The Efficacy of Soluble Fibre Supplementation for the Treatment of Pediatric Non-alcoholic Fatty Liver Disease (NAFLD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-Alcoholic Fatty Liver Disease
Non Alcoholic Steatohepatitis
Hepatic Steatosis
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants will be randomly allocated (1:1) to the OF+INU supplementation (intervention) or placebo group in a concealed fashion using REDCap databases, generated by a computer algorithm in permuted blocks of 2 and 4, to avoid imbalances. Study investigators and participants will be blinded to group allocation.
Primary purpose: TREATMENT

Brief 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.

Detailed description: The FIND (Fibre in Non-Alcoholic Fatty Liver Disease) study will be a single-centre, randomized, double-blind placebo-controlled trial comparing the effects of 6 months of mixed oligofructose and inulin (OF+INU) supplementation vs placebo on hepatic fat content, hepatic stiffness, metabolic outcomes, and body composition in children ages 8-17 years old.

Assessments such as MRI measurements of hepatic fat and hepatic stiffness, anthropometry and pubertal status questionnaires, and other investigations such as body composition via dual energy X-ray absorptiometry (DXA), fasting lipids, liver enzymes, blood glucose and oral-glucose tolerance (OGTT) tests will be performed; and randomization will be conducted via REDCap software.

Eighty participants will be enrolled for baseline evaluation in order to randomize sixty participants for the intervention phase (i.e. thirty participants per study group). Participants will consume one packet (4g) of OF+INU or placebo (Maltodextrin) daily. If tolerated, this will increase to one packet twice daily. Several strategies will be implemented to increase compliance, including text message reminders (daily for first week, then weekly), study calls to assess compliance and tolerability, and check-ins with participants at each clinic visit. These interactions will allow the study team to assess challenges and offer prompt support. Compliance will be assessed at each study visit by counting empty and unused sachets. Treatment with OF+INU or placebo will occur for 6 months, with study visits being conducted at baseline evaluation, 3 months and 6 months

Eligibility criteria: 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

Primary outcomes:
measure: Change in hepatic fat content.
timeFrame: Six months
Secondary outcomes:
measure: Change in hepatic stiffness.
timeFrame: Six months
measure: Change in glycemic control, or insulin resistance.
timeFrame: Six months
measure: Change in liver enzymes (ALT, AST, GGT, or ALP)
timeFrame: Six months
measure: Change in body fat percentage
timeFrame: Six months
measure: Change in weight
timeFrame: Six months
measure: Change in height
timeFrame: Six months
measure: Change in BMI
timeFrame: Six months
Other outcomes:
measure: Changes in molecular profiling of gut microbiome
timeFrame: Six months
Locations:
city: Hamilton
country: Canada
facility: McMaster University Medical Center
state: Ontario
Study officials:
affiliation: McMaster University
name: Nikhil Pai, MD
role: PRINCIPAL_INVESTIGATOR
References: