Actively Recruiting

Phase Not Applicable
Age: 12Years - 18Years
All Genders
NCT05528471

Fructose and Liver Diseases in Youth: Help Them FLY

Led by University of Alberta · Updated on 2024-10-09

70

Participants Needed

1

Research Sites

504 weeks

Total Duration

On this page

Sponsors

U

University of Alberta

Lead Sponsor

A

Alberta Health services

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

Fructose and Liver Diseases in Youth: Help Them FLY

Who Can Participate

Age: 12Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Obese boys and girls aged 12 to 18 years (Tanner Stage III-V) with clinically diagnosed non-alcoholic fatty liver disease (NAFLD)
Not Eligible

You will not qualify if you...

  • History of primary liver diseases causing steatohepatitis such as Wilson disease, metabolic disorders, or viral hepatitis
  • Diagnosis of Type 2 Diabetes or use of insulin
  • Use of medications causing liver fat buildup (methotrexate, corticosteroids, valproic acid, statins)
  • Evidence of bridging liver fibrosis
  • Significant history of smoking or alcohol use
  • Participation in an active weight loss program or prior bariatric surgery for obesity
  • Presence of a cardiac pacemaker or metal pins (contraindications for MRI/MRS)
  • Pregnancy or known pregnancy in females of childbearing potential
  • Significant developmental delay or serious health conditions preventing participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Clinical Research Unit, University of Alberta

Edmonton, Alberta, Canada, T6G 0K2

Actively Recruiting

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Research Team

D

Diana R Mager, PhD RD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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