Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03985020
• Other study ID #: CHLA-19-00212
• Status: Recruiting
• Phase: N/A
• Start date: July 26, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2023
• Source: Children's Hospital Los Angeles
• Contact: Asal Gholikhani, BA
• Phone: 323-361-1432
• Email: agholikhani[@]chla.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Other:
• Stevia Intervention
We will use commercially available stevia sweetened soft drink Zevia.
• Water Intervention
Bottled Water

Locations

Country	Name	City	State
United States	Children's Hospital of Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Fat percentage	Measured using DEXA	week 1 to 8 weeks (%)
Secondary	Change in kPA levels	Measured using MR elastography (non-sedated study)	week 1 to 8 weeks (kPA)
Secondary	Change in Height	Height will be measured in duplicate within .5cm.	week 1 to 8 weeks (cm)
Secondary	Change in Weight	Measured using an electric scale.	week 1 to 8 weeks (kg)
Secondary	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	week 1 to 8 weeks (cm)
Secondary	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.	week 1 to 8 weeks
Secondary	Change in Triglyceride levels	measured by fasting blood sample	week 1 to 8 weeks
Secondary	Change in Glucose Level	Measured by fasting blood samples	Week 1 to week 8 (mg/dl)
Secondary	Change in Insulin Level	Measured by fasting blood sample	Week 1 to week 8 (UIU/mL)