Soluble Fibre Supplement for Fatty Liver Disease (FIND Trial)

Phase 2

Recruiting

Led By Nikhil Pai, MD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six months

Summary

This trial will investigate if a supplement can help reduce liver fat in children with fatty liver disease. Subjects will get pills, have bloodwork & diet monitored, and have liver fat measured via MRI.

Who is the study for?

This trial is for children aged 8-17 with obesity and non-alcoholic fatty liver disease (NAFLD), evidenced by elevated ALT levels and hepatic steatosis. They must be enrolled in the GHWM Clinic without diabetes, other liver diseases, or contraindications to MRI. Those using other fibre supplements or with allergies to OF-INU supplementation are excluded.

What is being tested?

The FIND study tests if a mixed fibre supplement (oligofructose + inulin) can improve liver health in kids with NAFLD. Participants will randomly receive either this supplement or a placebo (Maltodextrin), have their diet analyzed, bloodwork done, and liver fat measured via MRI at St. Joseph's Hospital.

What are the potential side effects?

Potential side effects of the fibre supplement may include digestive discomfort such as bloating, gas, cramps, or diarrhea due to increased fiber intake. Allergic reactions could occur but are expected to be rare.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ six months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~six months

This trial's timeline: 3 weeks for screening, Varies for treatment, and six months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in hepatic fat content.

Secondary study objectives

Change in BMI

Body Weight Changes

Change in glycemic control, or insulin resistance.

+4 more

Other study objectives

Changes in molecular profiling of gut microbiome

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Oligofructose Inulin SupplementationExperimental Treatment1 Intervention

The intervention group will receive a daily fibre supplementation of (fructo-oligosaccharide enriched inulin, 4g twice daily; Orafti®Synergy1, BENEO), a tasteless white powder contained within a tear-able, partitioned 4g sachet, sprinkled and dissolved in 125 mL of water.

Group II: Maltodextrin SupplementationPlacebo Group1 Intervention

The control group will receive a daily supplementation of carbohydrate placebo (isocaloric maltodextrin), identical in colour, packaging, preparation, and dose (4g, twice daily; C\*Dry MD™,Cargill).

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