Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis

NCT03985020 | Completed

• 1 other identifier: CHLA-19-00212
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.Standard of care
2. 2.Water delivery
3. 3.Water with Rebaudioside (stevia natural sweetener)

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• 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

  Week 1 to week 8 (IU/L)

Secondary Outcomes (9)

• Change in Fat percentage

  week 1 to 8 weeks (%)

• Change in kPA levels

  week 1 to 8 weeks (kPA)

• Change in Height

  week 1 to 8 weeks (cm)

• Change in Weight

  week 1 to 8 weeks (kg)

• Change in Waist Circumference

  week 1 to 8 weeks (cm)

Study Arms (3)

Standard of Care

NO INTERVENTION

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

Water Intervention

ACTIVE COMPARATOR

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.

Other: Water Intervention

Stevia Intervention

EXPERIMENTAL

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

Other: Stevia Intervention

Interventions

Stevia Intervention OTHER

We will use commercially available stevia sweetened soft drink Zevia.

Stevia Intervention

Water Intervention OTHER

Bottled Water

Water Intervention

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Tania Mitsinikos, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

• Rohit Kohli, MBBS, MS

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Staff/USC Faculty CWR

Model Details: Participants will be randomly assigned to one of three possible groups.

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 13, 2019
• Study Start: July 26, 2019
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 5, 2024

Record last verified: 2024-09

Locations

US (1)