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Dietary Supplement

Soluble Fibre Supplement for Fatty Liver Disease (FIND Trial)

Phase 1

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

Awards & highlights

FIND Trial 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.Check my eligibility

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.See study design

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.

FIND Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in hepatic fat content.

Secondary outcome measures

Change in BMI

Body Weight Changes

Change in glycemic control, or insulin resistance.

+4 more

Other outcome measures

Changes in molecular profiling of gut microbiome

FIND 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).

Do I qualify?Apply below to find out

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Who is running the clinical trial?

McMaster UniversityLead Sponsor

884 Previous Clinical Trials

2,598,256 Total Patients Enrolled

1 Trials studying Non-alcoholic Fatty Liver Disease

60 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,454 Total Patients Enrolled

11 Trials studying Non-alcoholic Fatty Liver Disease

755 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Nikhil Pai, MDPrincipal InvestigatorMcMaster University

1 Previous Clinical Trials

20 Total Patients Enrolled

Media Library

Fructo-oligosaccharide enriched inulin supplement (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05480696 — Phase 1

Non-alcoholic Fatty Liver Disease Research Study Groups: Oligofructose Inulin Supplementation, Maltodextrin Supplementation

Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Fructo-oligosaccharide enriched inulin supplement Highlights & Side Effects. Trial Name: NCT05480696 — Phase 1

Fructo-oligosaccharide enriched inulin supplement (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05480696 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are adults of any age allowed to participate in this research?

"In order to be admitted into this trial, applicants must fall between the age range of 8 and 17."

Answered by AI

Has Oligofructose Inulin Supplementation been granted authorization by the FDA?

"Our internal evaluation at Power gave Oligofructose Inulin Supplementation a score of 1 due to its limited prior success in clinical trials, and the lack of data supporting safety."

Answered by AI

Is enrollment for this experimentation open at the present moment?

"Affirmative. According to the clinicaltrials.gov database, this research is still open for recruitment; it was first uploaded on September 9th 2022 before being modified on March 13th 2023. Sixty participants are needed from a single site."

Answered by AI

Do I qualify to take part in this clinical investigation?

"This investigation is looking for pediatric patients, aged between 8 and 17 years with non-alcoholic fatty liver disease to join the study. The team hopes to enrol 60 participants in total."

Answered by AI

How many individuals are being enrolled in this investigation?

"Affirmative. Clinicaltrials.gov data reveals that this research, which was first posted on September 9th 2022, is actively seeking participants. 60 people need to be enrolled from a single location for the trial to commence."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Soluble Fibre Supplementation in NAFLD

2022. "Soluble Fibre Supplementation in NAFLD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05480696.

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