Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Non Alcoholic Fatty Liver Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants will be randomly assigned to one of three possible groups.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 10 years and 18 years
- Gender
- Both males and females
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 ...
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: Standard of Care Water Delivery 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.
Tracking Information
- NCT #
- NCT03985020
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Tania Mitsinikos, MD Children's Hospital Los Angeles
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