Soluble Fibre Supplementation in NAFLD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fructo-oligosaccharide enriched inulin supplement, Maltodextrin.
- Who it may be relevant to
- Registry conditions: Non-Alcoholic Fatty Liver Disease, Non Alcoholic Steatohepatitis, Hepatic Steatosis. Basic parameters: 8 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Efficacy of Soluble Fibre Supplementation for the Treatment of Pediatric Non-alcoholic Fatty Liver Disease (NAFLD)
Overview
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
Interventions
- Dietary supplement Fructo-oligosaccharide enriched inulin supplement
Experiment - Other Maltodextrin
Placebo.
Primary outcome measures
- Change in hepatic fat content. [Time frame: Six months]
Secondary outcome measures (7)
- Change in hepatic stiffness. [Time frame: Six months]
- Change in glycemic control, or insulin resistance. [Time frame: Six months]
- Change in liver enzymes (ALT, AST, GGT, or ALP) [Time frame: Six months]
- Change in body fat percentage [Time frame: Six months]
- Change in weight [Time frame: Six months]
- Change in height [Time frame: Six months]
- Change in BMI [Time frame: Six 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- McMaster University Medical Center — Hamilton
Identifiers
NCT: NCT05480696 · 14888 · 471270