Dietary intervention for adolescents with non-alcoholic fatty liver disease
Dietary Fructose as a Mediator to Altered Liver Energy Metabolism and Oxidative Stress in Youth With Non-alcoholic Fatty Liver Disease: HELP THEM FLY.
This study tests if a low fructose diet can help teenagers with non-alcoholic fatty liver disease improve their liver health and metabolism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT05528471 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of a low fructose diet on adolescents diagnosed with non-alcoholic fatty liver disease (NAFLD). It aims to determine how reducing fructose intake can improve liver function and metabolic health in obese youth. Participants will follow a dietary intervention designed to lower their fructose consumption, and the effects on liver health and insulin resistance will be monitored. The study builds on previous findings that link high fructose intake to worsening liver conditions in children.
Who should consider this trial
Good fit: Ideal candidates are obese boys and girls aged 12-18 years with a clinically diagnosed case of NAFLD.
Not a fit: Patients with a history of primary liver disease, Type 2 Diabetes, or those on medications causing hepatic steatosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a dietary approach to effectively manage and improve liver health in adolescents with NAFLD.
How similar studies have performed: Previous studies have shown promising results with dietary interventions in managing NAFLD, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * obese boys and girls aged 12-18 years (Tanner Stage: III-V) with clinically diagnosed NAFLD Exclusion Criteria: 1. all patients with a history of a known primary liver disease associated with steatohepatitis (Wilson disease, various metabolic disorders, viral hepatitis) (7); 2. All patients with a known primary diagnosis of Type 2 Diabetes or those on insulin; 3. Patients on medications known to cause hepatic steatosis (e.g., methotrexate, corticosteroids, valproic acid, statins); 4. Patients with evidence of bridging fibrosis (8); and 5. Patients with a known significant history of smoking or alcohol consumption (6, 9) and 6. Any patient undergoing an active weight loss program and/or who has received bariatric surgery for the treatment of obesity 7. Any participant with a cardiac pacemaker or with metal pins as this is a contraindication for MRS/MRI testing 8. Any participant of child bearing potential who is known to be pregnant (as this is a contraindication to MRS/MRI) testing. All females of child bearing potential will be asked to undergo a routine pregnancy test (urine) prior to MRS/MRI testing. This will be conducted in the baseline study visit 9. Any child with significant developmental delay or a significant co-morbidity that precluded the ability to participate in study procedures
Where this trial is running
Edmonton, Alberta
- Clinical Research Unit, University of Alberta — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Diana R Mager, PhD RD — University of Alberta
- Study coordinator: Diana R Mager, PhD RD
- Email: mager@ualberta.ca
- Phone: 780-492-7687
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.