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OpenTrials
Completed

NCT Number: NCT03985020

Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis

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)

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

About this study

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:

  • Standard of Care
  • Water Delivery
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stevia Intervention

Other

We will use commercially available stevia sweetened soft drink Zevia.

Water Intervention

Other

Bottled Water

Primary outcomes

  1. Change in Alanine Transaminase (ALT)

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

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

Secondary outcomes

  1. Change in Fat percentage

    Time frame: week 1 to 8 weeks (%)

    Measured using DEXA

  2. Change in kPA levels

    Time frame: week 1 to 8 weeks (kPA)

    Measured using MR elastography (non-sedated study)

  3. Change in Height

    Time frame: week 1 to 8 weeks (cm)

    Height will be measured in duplicate within .5cm.

  4. Change in Weight

    Time frame: week 1 to 8 weeks (kg)

    Measured using an electric scale.

  5. Change in Waist Circumference

    Time frame: week 1 to 8 weeks (cm)

    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

  6. Change in Acanthosis nigricans skin exam

    Time frame: week 1 to 8 weeks

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

  7. Change in Triglyceride levels

    Time frame: week 1 to 8 weeks

    measured by fasting blood sample

  8. Change in Glucose Level

    Time frame: Week 1 to week 8 (mg/dl)

    Measured by fasting blood samples

  9. Change in Insulin Level

    Time frame: Week 1 to week 8 (UIU/mL)

    Measured by fasting blood sample

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jun 13, 2019
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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