Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis

  • STATUS
    Recruiting
  • End date
    Mar 1, 2023
  • participants needed
    60
  • sponsor
    Children's Hospital Los Angeles
Updated on 5 July 2022
liver disease
fatty liver
steatosis

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)

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.

Details
Condition Non-Alcoholic Fatty Liver Disease
Treatment Stevia Intervention, Water Intervention
Clinical Study IdentifierNCT03985020
SponsorChildren's Hospital Los Angeles
Last Modified on5 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age: 10-18 years
ALT > 45 IU/L (twice the normal amount)
BMI >85%
Fat >5% and kPa> 2.7

Exclusion Criteria

Physician diagnosis of a major medical illness including, but not limited to, chronic liver disease, immunodeficiency disorder, hypothalamic obesity, or a genetic cause of obesity
Familial hyperlipidemia
Positive hepatitis lab
Antibiotics within 1 month of beginning the study
Physical, mental, or cognitive issues preventing participation
Pregnancy
Smoking or drinking
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