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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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 3 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in 31P spectra from abdominal MRI scans in response to dietary intervention.
Secondary study objectives
Change in cardio-metabolic risk factors in response to the dietary intervention
Body Weight Changes
Liver
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,388 Previous Clinical Trials
26,518,003 Total Patients Enrolled
11 Trials studying Non-alcoholic Fatty Liver Disease
745 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Alberta Health servicesOTHER
163 Previous Clinical Trials
652,588 Total Patients Enrolled
University of AlbertaLead Sponsor
940 Previous Clinical Trials
433,973 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
~1 spots leftby Dec 2024
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