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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 3 months
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 moreAwards & 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
1,392 Previous Clinical Trials
26,527,396 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
942 Previous Clinical Trials
434,339 Total Patients Enrolled
Diana R Mager, PhD RDPrincipal InvestigatorUniversity of Alberta
1 Previous Clinical Trials
120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Type 2 Diabetes or I am on insulin.I have a liver condition related to fat buildup, like fatty liver disease.I am currently in a weight loss program or have had bariatric surgery.I am taking medication that can affect my liver, like methotrexate or steroids.My child cannot participate in study procedures due to a significant developmental delay or other major health issue.I am not pregnant and can take a pregnancy test before the MRI.I am an obese teenager with a diagnosed liver condition.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention group
- Group 2: Control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.