Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT03985020
Status:
COMPLETED
Last Update Posted:
2024-09-05
First Post:
2019-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis
Sponsor:
Children's Hospital Los Angeles
Organization:
Study Overview
Official Title:
Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: