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Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis

Primary Purpose

Non-Alcoholic Fatty Liver Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stevia Intervention
Water Intervention
Sponsored by
Children's Hospital Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Children's Hospital of Los AngelesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Standard of Care

Water Intervention

Stevia Intervention

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Fat percentage
Measured using DEXA
Change in kPA levels
Measured using MR elastography (non-sedated study)
Change in Height
Height will be measured in duplicate within .5cm.
Change in Weight
Measured using an electric scale.
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
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.
Change in Triglyceride levels
measured by fasting blood sample
Change in Glucose Level
Measured by fasting blood samples
Change in Insulin Level
Measured by fasting blood sample

Full Information

First Posted
June 6, 2019
Last Updated
August 29, 2023
Sponsor
Children's Hospital Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT03985020
Brief Title
Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis
Official Title
Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2019 (Actual)
Primary Completion Date
March 14, 2024 (Anticipated)
Study Completion Date
December 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: Standard of care Water delivery 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to one of three possible groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
The control group will receive standard of care dietary advice for their solid food and beverage intake.
Arm Title
Water Intervention
Arm Type
Active Comparator
Arm 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.
Arm Title
Stevia Intervention
Arm Type
Experimental
Arm 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
Intervention Type
Other
Intervention Name(s)
Stevia Intervention
Intervention Description
We will use commercially available stevia sweetened soft drink Zevia.
Intervention Type
Other
Intervention Name(s)
Water Intervention
Intervention Description
Bottled Water
Primary Outcome Measure Information:
Title
Change in ALT
Description
A fasting blood sample will be taken at baseline and week 8 and assess change over time in all 3 groups
Time Frame
Week 1 to week 8 (IU/L)
Secondary Outcome Measure Information:
Title
Change in Fat percentage
Description
Measured using DEXA
Time Frame
week 1 to 8 weeks (%)
Title
Change in kPA levels
Description
Measured using MR elastography (non-sedated study)
Time Frame
week 1 to 8 weeks (kPA)
Title
Change in Height
Description
Height will be measured in duplicate within .5cm.
Time Frame
week 1 to 8 weeks (cm)
Title
Change in Weight
Description
Measured using an electric scale.
Time Frame
week 1 to 8 weeks (kg)
Title
Change in Waist Circumference
Description
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
Time Frame
week 1 to 8 weeks (cm)
Title
Change in Acanthosis nigricans skin exam
Description
An Acanthosis Nigricans (AN) skin exam will be performed at each visit. Acanthosis Nigricans is an indicator for disorders of insulin resistance.
Time Frame
week 1 to 8 weeks
Title
Change in Triglyceride levels
Description
measured by fasting blood sample
Time Frame
week 1 to 8 weeks
Title
Change in Glucose Level
Description
Measured by fasting blood samples
Time Frame
Week 1 to week 8 (mg/dl)
Title
Change in Insulin Level
Description
Measured by fasting blood sample
Time Frame
Week 1 to week 8 (UIU/mL)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asal Gholikhani, BA
Phone
323-361-1432
Email
agholikhani@chla.usc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ronald Martinez
Phone
323-361-3402
Email
rmartinezgalan@chla.usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tania Mitsinikos, MD
Organizational Affiliation
Children's Hospital Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rohit Kohli, MBBS, MS
Organizational Affiliation
Children's Hospital Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asal Gholikhani
Phone
323-361-1432
Email
agholikhani@chla.usc.edu

12. IPD Sharing Statement

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Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis

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