Clinical trial NCT03985020: 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
Overall status: COMPLETED
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2019-06-13
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of three possible groups.
Primary purpose: TREATMENT

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)

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.

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

Primary outcomes:
measure: Change in Alanine Transaminase (ALT)
timeFrame: Week 1 to week 8 (IU/L)
Secondary outcomes:
measure: Change in Fat percentage
timeFrame: week 1 to 8 weeks (%)
measure: Change in kPA levels
timeFrame: week 1 to 8 weeks (kPA)
measure: Change in Height
timeFrame: week 1 to 8 weeks (cm)
measure: Change in Weight
timeFrame: week 1 to 8 weeks (kg)
measure: Change in Waist Circumference
timeFrame: week 1 to 8 weeks (cm)
measure: Change in Acanthosis nigricans skin exam
timeFrame: week 1 to 8 weeks
measure: Change in Triglyceride levels
timeFrame: week 1 to 8 weeks
measure: Change in Glucose Level
timeFrame: Week 1 to week 8 (mg/dl)
measure: Change in Insulin Level
timeFrame: Week 1 to week 8 (UIU/mL)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Tania Mitsinikos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Los Angeles
name: Rohit Kohli, MBBS, MS
role: PRINCIPAL_INVESTIGATOR
References: