Fructose and Liver Diseases in Youth: Help Them FLY

NCT05528471 | Recruiting

• 1 other identifier: Pro00049795
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in 31P spectra from abdominal MRI scans in response to dietary intervention.

  Changes in area under the curve (AUC) for 31P spectra obtained from abdominal Magnetic Resonance Scan between baseline and 3 months between individuals and between study arms. We will calculate the difference (baseline value-3 months value) for each individual to determine the change from baseline. This will be done in both groups.

  Change from baseline to 3 months

Secondary Outcomes (5)

• Change in hepatic intramyocellular surface area in response to dietary intervention.

  Change from baseline to 3 months

• Change in visceral adipose tissue (VAT cm3/ht2) and subcutaneous adipose tissue (SAT cm3/ht2) surface area in response to the dietary intervention

  Change from baseline to 3 months

• Change in markers of liver dysfunction in response to the dietary intervention

  Change from baseline to 3 months

• Change in cardio-metabolic risk factors in response to the dietary intervention

  Change from baseline to 3 months

• Change in measures of insulin resistance in response to the dietary intervention

  Change from baseline to 3 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Other: Dietary intervention

Control group

NO INTERVENTION

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

Interventions

Dietary intervention OTHER

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.

Also known as: Fructose intervention

Intervention group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• obese boys and girls aged 12-18 years (Tanner Stage: III-V) with clinically diagnosed NAFLD

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Clinical Research Unit, University of Alberta

Edmonton, Alberta, T6G 0K2, Canada

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Diana R Mager, PhD RD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana R Mager, PhD RD

CONTACT

780-492-7687; mager@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 6, 2022
• Study Start: April 30, 2015
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

CA (1)