Effect of a fibre supplement on children with fatty liver disease
Official title: The Efficacy of Soluble Fibre Supplementation for the Treatment of Pediatric Non-alcoholic Fatty Liver Disease (NAFLD)
Run by McMaster University · NCT05480696 · Data updated 2026-11-12
This study is testing whether a fiber supplement can help children aged 8-17 with fatty liver disease improve their liver health over six months.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 8 Years to 17 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | McMaster University Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Status | Recruiting |
| Started | September 9, 2022 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | November 12, 2024 |
| Trial ID | NCT05480696 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 8-17 with obesity and clinical evidence of NAFLD.
✕Probably not a fit
Patients with diabetes, other liver diseases, or contraindications to MRI will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The FIND study investigates the impact of a nutritional mixed fibre supplement, oligofructose and inulin (OF+INU), on children aged 8-17 diagnosed with non-alcoholic fatty liver disease (NAFLD). This randomized, double-blind, placebo-controlled trial will enroll participants who will receive either the fibre supplement or a placebo for six months. Participants will undergo various assessments, including MRI measurements of liver fat and stiffness, blood tests, and dietary evaluations to monitor the effects of the intervention. The study aims to enhance compliance through regular check-ins and reminders.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive dietary intervention to improve liver health in children with NAFLD.
How similar studies have gone: While similar approaches have been explored, this specific intervention with OF+INU in children with NAFLD is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
McMaster University Medical Center
Hamilton, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Nikhil Pai, MD — McMaster University
- Study coordinator: Paige AL Cheveldayoff, BSC
- Email: cheveldp@mcmaster.ca
- Phone: 3063611281
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.