Recruiting

Fructose & Liver

Sponsor:

University of Alberta

Code:

NCT05528471

Conditions

Non-alcoholic Fatty Liver Disease

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

Dietary intervention

Study Details

Brief 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

Study ID

NCT05528471

Start date

Apr 30, 2015

Status verified date

Oct, 2024

Completion date

Dec 30, 2024

Anticipated

Primary completion date

Dec 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention group

Iso-caloric and low fructose /low HFCS diet (\~5% of total energy intake (TEI); HFCS max: 10-15% of total fructose intake) (n=35)

no intervention: Control group

Iso-caloric with higher fructose diet (\~10% of TEI; HFCS max 20-30% of total fructose intake) (n=35)

Interventions

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.

Primary outcome measure

  • Change in 31P spectra from abdominal MRI scans in response to dietary intervention. [ Time Frame: Change from baseline to 3 months ]

Central Contacts and Locations

Central contacts

Diana R Mager, PhD RD

780-492-7687mager@ualberta.ca

Locations

Clinical Research Unit, University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 0K2

Principal Investigator:

Diana R Mager, PhD RD

More Information

Sponsor

University of Alberta

Last update posted

Oct 9, 2024

Last verified

Oct, 2024

Keywords

  • Non-alcoholic fatty liver disease
  • Fructose
  • Hepatic energetics
  • Hepatic fat fraction
  • Adolescents

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2024-10-09.