MedTrace Logo

Fructose and Liver Diseases in Youth: Help Them FLY

NCT05528471 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-10-09

No results posted yet for this study

Summary

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.

Conditions

  • Non-alcoholic Fatty Liver Disease

Interventions

OTHER

Dietary intervention

To compare an iso-caloric, low fructose diet (\~5% of total energy intake (TEI); HFCS max: 10-15% of total fructose intake) to an iso-caloric, higher fructose diet (\~10% of TEI; HFCS max 20-30% of total fructose intake) in adolescents with NAFLD. The 10% higher fructose diet is part of standard of care and is NOT the intervention.

Sponsors & Collaborators

  • Alberta Health services

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University of Alberta

    lead OTHER

Principal Investigators

  • Diana R Mager, PhD RD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2024-12-30
Completion
2024-12-30

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05528471 on ClinicalTrials.gov