NCT05480696RecruitingPhase 2
Soluble Fibre Supplementation in NAFLD
The Efficacy of Soluble Fibre Supplementation for the Treatment of Pediatric Non-alcoholic Fatty Liver Disease (NAFLD)
Source: ClinicalTrials.gov · Last updated 12 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 22 Jul 2022
- Start date
- 9 Sept 2022
- Primary completion date
- Mar 2027
- Lead sponsor
- McMaster University
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05480696
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 9 Sept 2022 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to having MRI (claustrophobia, metal implant, recent tattoo, weight \> 300lbs)
- Concomitant use of other fibre supplements
Other illness
- Type 1, Type 2 diabetes mellitus (T1DM, T2DM)
- Presence of another known cause of liver disease
- Known allergy or hypersensitivity to OF-INU supplementation
Lab values
- Medications known to affect hepatic fat content, taken within the past year (i.e., glucocorticoids, anabolic steroids, tetracycline, anticonvulsants, antipsychotics, glucose- lowering medications)
Other
- Self-reported alcohol intake \>7 drinks/week or 3 drinks/day
Who the study is looking for
- 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).
Age in the registry: 8 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McMaster University Medical Center Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.