Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis

NCT ID: NCT03985020

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-26
• Study Completion Date: 2024-08-01

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)

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Water Intervention

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.

Group Type: ACTIVE_COMPARATOR

Water Intervention

Intervention Type: OTHER

Bottled Water

Stevia Intervention

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

Group Type: EXPERIMENTAL

Stevia Intervention

Intervention Type: OTHER

We will use commercially available stevia sweetened soft drink Zevia.

Interventions

Stevia Intervention

We will use commercially available stevia sweetened soft drink Zevia.

Intervention Type: OTHER

Water Intervention

Bottled Water

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Tania Mitsinikos

Medical Staff/USC Faculty CWR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tania Mitsinikos, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Rohit Kohli, MBBS, MS

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Locations

Children's Hospital of Los Angeles

Los Angeles, California, United States

Countries

United States

Other Identifiers

CHLA-19-00212

Identifier Type: -

Identifier Source: org_study_id