Soluble Fibre Supplementation in NAFLD

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Non-Alcoholic Fatty Liver Disease, Non Alcoholic Steatohepatitis, Hepatic Steatosis

In brief

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.

Key facts

Study ID

NCT05480696

Run by

McMaster University

People needed

60

Starts

2022-09-09

Expected to finish

2027-03-01

Last updated by the study team

2024-11-12

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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 is running

• McMaster University Medical Center — Hamilton, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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