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Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis

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ClinicalTrials.gov Identifier: NCT03985020
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Tania Mitsinikos, Children's Hospital Los Angeles

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)

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Other: Stevia Intervention Other: Water Intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to one of three possible groups.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis
Estimated Study Start Date : September 8, 2019
Estimated Primary Completion Date : September 8, 2020
Estimated Study Completion Date : December 8, 2020


Arm Intervention/treatment
No Intervention: Standard of Care
The control group will receive standard of care dietary advice for their solid food and beverage intake.
Active Comparator: 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.
Other: Water Intervention
Bottled Water

Experimental: 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
Other: Stevia Intervention
We will use commercially available stevia sweetened soft drink Zevia.




Primary Outcome Measures :
  1. Change in 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 Outcome Measures :
  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



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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985020


Contacts
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Contact: Dalia Salazar 323-361-1920 dasalazar@chla.usc.edu

Sponsors and Collaborators
Children's Hospital Los Angeles
Investigators
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Principal Investigator: Tania Mitsinikos, MD Children's Hospital Los Angeles

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Responsible Party: Tania Mitsinikos, Medical Staff/USC Faculty CWR, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT03985020     History of Changes
Other Study ID Numbers: 19-00212
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases