Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis

Children's Hospital Los Angeles

Status: Completed

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Other: Stevia Intervention; Other: Water Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03985020

CHLA-19-00212

Details and patient eligibility

About

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)

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Standard of Care

No Intervention group

Description:

The control group will receive standard of care dietary advice for their solid food and beverage intake.

Water Intervention

Active Comparator group

Description:

We will order and deliver bottled water to the homes of subjects in the treatment group. We will provide each participant with a weekly supply of about 36 16.9 fl oz single-serving containers. We will instruct subjects to notify us by calling a dedicated telephone line on occasions when a delivery is expected but not received so that the problem can be corrected expeditiously.

Treatment:

Other: Water Intervention

Stevia Intervention

Experimental group

Description:

We will order and deliver a commercially-available stevia-sweetened soft drink Zevia (Los Angeles, CA) to each participant in the treatment group. We will provide each participant with a weekly supply of 24 12 fl oz single-serving containers. Zevia will be provided in an assortment of flavors for the first week, then catered to the preference of the participant for the remainder of the study. We will instruct subjects to notify us by calling a dedicated telephone line on occasions when a delivery is expected but not received so that the problem can be corrected expeditiously. Participants will also be asked to keep track of how many containers they consume using a sticker chart, and we will also phone parents weekly to verify the sticker charts

Treatment:

Other: Stevia Intervention