NCT03985020

Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Children's Hospital Los Angeles · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

In order to determine whether rebaudioside consumption can be used as a treatment for adolescents with Non-alcoholic Fatty Liver Disease (NAFLD) by demonstrating a decrease in alanine aminotransferase (ALT) levels participants will be randomized to receive one of three 8-week liquid diet interventions: 1. Standard of care 2. Water delivery 3. Water with Rebaudioside (stevia natural sweetener)

Detailed description

Rationale: Current treatment strategies for Nonalcoholic fatty liver disease, NAFLD, have focused on lifestyle management through a combination of diet and exercise but there are no recommendations for dietary changes that have been proven superior to others. Preliminary data showing an improvement in liver enzymes and fibrosis in mice has demonstrated a novel use of rebaudioside, the non-caloric sweetener (NCS) Stevia leaf's extract, potentially identifying this NCS as a therapeutic intervention where currently there are no targeted treatments. Intervention: All participants will receive standard of care for diet and nutrition. Additionally, participants will be randomized to one of four 8-week liquid diet interventions: 1. Standard of Care 2. Water Delivery 3. Water with Rebaudioside (Stevia Natural Sweetener) Objectives and Purpose: To determine whether rebaudioside consumption can be used as a treatment for adolescents with NAFLD by demonstrating a decrease in ALT levels.

Conditions

• Non-Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
OTHER	Stevia Intervention	We will use commercially available stevia sweetened soft drink Zevia.
OTHER	Water Intervention	Bottled Water

Timeline

• Start date: 2019-07-26
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2019-06-13
• Last updated: 2024-09-05

Locations

1 site across 1 country: United States