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Low-Fructose Diet for Fatty Liver Disease in Youth (FLY Trial)

N/A
Recruiting
Led By Diana R Mager, PhD RD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Obese boys and girls aged 12-18 years (Tanner Stage: III-V) with clinically diagnosed NAFLD
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 3 months
Awards & highlights

FLY Trial Summary

This trial will compare how two different diets (high vs low in high fructose corn syrup or HFCS) may affect how much fat gets deposited in the liver and whether or not a lower diet in HFCS can help decrease liver damage in adolescents with non-alcoholic fatty liver disease (NAFLD).

Who is the study for?
This trial is for obese boys and girls aged 12-18 with diagnosed non-alcoholic fatty liver disease (NAFLD). They shouldn't have other liver diseases, be on certain medications like corticosteroids or methotrexate, have a history of significant smoking or alcohol use, be pregnant, have type 2 diabetes or insulin use, severe fibrosis in the liver, metal implants incompatible with MRI scans, or any condition that prevents participation in study procedures.Check my eligibility
What is being tested?
The 'Help Them FLY' trial is testing how two different diets affect fat storage in the liver of adolescents with NAFLD. One diet has high levels of high fructose corn syrup (HFCS), while the other has low HFCS. The goal is to see if a low-HFCS diet can reduce liver damage without weight loss.See study design
What are the potential side effects?
Since this is a dietary intervention focusing on reducing high fructose corn syrup intake rather than medication or surgery, side effects are minimal but may include changes in bowel habits due to dietary adjustments.

FLY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am an obese teenager with a diagnosed liver condition.

FLY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 3 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 31P spectra from abdominal MRI scans in response to dietary intervention.
Secondary outcome measures
Change in cardio-metabolic risk factors in response to the dietary intervention
Body Weight Changes
Liver
+2 more

FLY Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment1 Intervention
Iso-caloric and low fructose /low HFCS diet (~5% of total energy intake (TEI); HFCS max: 10-15% of total fructose intake) (n=35)
Group II: Control groupActive Control1 Intervention
Iso-caloric with higher fructose diet (~10% of TEI; HFCS max 20-30% of total fructose intake) (n=35)

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,340 Previous Clinical Trials
26,452,628 Total Patients Enrolled
11 Trials studying Non-alcoholic Fatty Liver Disease
745 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Alberta Health servicesOTHER
157 Previous Clinical Trials
649,474 Total Patients Enrolled
University of AlbertaLead Sponsor
886 Previous Clinical Trials
384,708 Total Patients Enrolled

Media Library

HFCS-restricted Diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05528471 — N/A
Non-alcoholic Fatty Liver Disease Research Study Groups: Intervention group, Control group
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: HFCS-restricted Diet Highlights & Side Effects. Trial Name: NCT05528471 — N/A
HFCS-restricted Diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05528471 — N/A

Frequently Asked Questions

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

How many participants have been accepted in to this research project?

"Affirmative. According to clinicaltrials.gov, this experiment commenced recruitment on April 30th 2015 and is still actively recruiting participants; the most recent version was updated on September 2nd 2022. The research needs 70 people from a single facility."

Answered by AI

Could I potentially qualify to take part in this exploration?

"This research project is enrolling 70 individuals between 12 and 18 years old, who have been clinically diagnosed with nonalcoholic steatohepatitis. Furthermore, candidates must be classified as obese through the Tanner Stage III-V criteria."

Answered by AI

Does this research encompass individuals aged thirty and above?

"In order to be considered for this trial, participants must fit the age criteria of 12-18 years. 33 trials are available specifically for those under 18 while 319 have been constructed with individuals above 65 in mind."

Answered by AI

Is enrollment for this investigative trial open at present?

"This clinical trial is currently seeking to enroll participants. The initial posting of the study was on April 30th 2015 and it has been most recently updated as of September 2nd 2022, according to data hosted by clinicaltrials.gov."

Answered by AI

Who else is applying?

What state do they live in?
California
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
0
What site did they apply to?
Clinical Research Unit, University of Alberta

Why did patients apply to this trial?

I HAD PRIOR HEP C treatments. Want to help scientific inquiry. So accidentally come out and maybe help someone.
PatientReceived 2+ prior treatments
I never been it was funny before I would like to know more about my neighbor and now I can help someone else.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Fructose and Liver Diseases in Youth: Help Them FLY
2015. "Fructose and Liver Diseases in Youth: Help Them FLY". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05528471.
All > Nonalcoholic Fatty Liver Disease > Nash
~1 spots leftby Jun 2024
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