Low-Fructose Diet for Fatty Liver Disease in Youth
(FLY Trial)

Recruiting in Palo Alto (17 mi)

Overseen byDiana R Mager, PhD RD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alberta

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I am an obese teenager with a diagnosed liver condition.

Exclusion Criteria

I have Type 2 Diabetes or I am on insulin.

Patients with a known significant history of smoking or alcohol consumption

I have a liver condition related to fat buildup, like fatty liver disease.

See 6 more

Treatment Details

Interventions

HFCS-restricted Diet (Other)
High HFCS Diet (Other)

Trial OverviewThe '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.

Participant Groups

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)