Fructose and Liver Diseases in Youth: Help Them FLY
Recruiting · NCT05528471 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Alberta
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Obesity has been increasing all over the world. This has lead to a significant increase of a liver disease in children called non-alcoholic fatty liver disease (NAFLD). NAFLD is a liver disease that ranges from excess fat being stored in the liver to an inflamed and fatty liver with fibrosis to cirrhosis. NAFLD is thought to be caused by changes in energy, fat and carbohydrate metabolism induced by diets high in in processed foods. Sugary (especially high fructose corn syrup or HFCS) and fatty foods in processed foods have been shown to produce more insulin resistance, a factor that is thought to cause a fatty liver. Currently the main treatment for NAFLD is weight loss. However, it unknown the best way to achieve this. The investigator has shown previously that adolescents with NAFLD eat a lot of fatty and sugary foods, and that when they decrease the amount of foods they eat that contain HFCS, experience some improvements in insulin resistance and liver dysfunction even when they don't lose weight. The plan is to compare and contrast how two different diets (high vs low HFCS containing diets) 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 NAFLD.
Who can take part
Inclusion criteria
- obese boys and girls aged 12-18 years (Tanner Stage: III-V) with clinically diagnosed NAFLD
Exclusion criteria
- all patients with a history of a known primary liver disease associated with steatohepatitis (Wilson disease, various metabolic disorders, viral hepatitis) (7);
- All patients with a known primary diagnosis of Type 2 Diabetes or those on insulin;
- Patients on medications known to cause hepatic steatosis (e.g., methotrexate, corticosteroids, valproic acid, statins);
- Patients with evidence of bridging fibrosis (8); and
- Patients with a known significant history of smoking or alcohol consumption (6, 9) and
- Any patient undergoing an active weight loss program and/or who has received bariatric surgery for the treatment of obesity
- Any participant with a cardiac pacemaker or with metal pins as this is a contraindication for MRS/MRI testing
- 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
- Any child with significant developmental delay or a significant co-morbidity that precluded the ability to participate in study procedures
Where it is running
1 location listed.
- Clinical Research Unit, University of Alberta - Edmonton, Alberta, Canada