Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis

Children's Hospital Los Angeles20 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Alcoholic Fatty Liver Disease

Interventions

Stevia InterventionOTHER

We will use commercially available stevia sweetened soft drink Zevia.

Water InterventionOTHER

Bottled Water

Eligibility

Sex: ALLMin age: 10 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital of Los Angeles

Los Angeles, California, United States

Outcomes

Primary Outcomes

Change in Alanine Transaminase (ALT)

A fasting blood sample will be taken at baseline and week 8 and assess change over time in all 3 groups

Time frame: Week 1 to week 8 (IU/L)

Secondary Outcomes

Change in Fat percentage

Measured using DEXA

Time frame: week 1 to 8 weeks (%)

Change in kPA levels

Measured using MR elastography (non-sedated study)

Time frame: week 1 to 8 weeks (kPA)

Change in Height

Height will be measured in duplicate within .5cm.

Time frame: week 1 to 8 weeks (cm)

Change in Weight

Measured using an electric scale.

Time frame: week 1 to 8 weeks (kg)

Change in Waist Circumference

Hip-to-waist ratio will be calculated using a measuring tape that does not stretch, measuring twice at hip-level and twice at waist-level and averaging the results

Time frame: week 1 to 8 weeks (cm)

Change in Acanthosis nigricans skin exam

An Acanthosis Nigricans (AN) skin exam will be performed at each visit. Acanthosis Nigricans is an indicator for disorders of insulin resistance.

Time frame: week 1 to 8 weeks

Change in Triglyceride levels

measured by fasting blood sample

Time frame: week 1 to 8 weeks

Data from ClinicalTrials.gov

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