Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Interventions
- Other: Water InterventionOther: Stevia Intervention
- Registration Number
- NCT03985020
- Lead Sponsor
- 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)
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Age: 10-18 years
- ALT > 45 IU/L (twice the normal amount)
- BMI >85%
- Fat >5% and kPa> 2.7
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Water Intervention 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. Stevia Intervention 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
- Primary Outcome Measures
Name Time Method Change in Alanine Transaminase (ALT) 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
Name Time Method Change in Fat percentage week 1 to 8 weeks (%) Measured using DEXA
Change in Waist Circumference 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
Change in Weight week 1 to 8 weeks (kg) Measured using an electric scale.
Change in Triglyceride levels week 1 to 8 weeks measured by fasting blood sample
Change in kPA levels week 1 to 8 weeks (kPA) Measured using MR elastography (non-sedated study)
Change in Height week 1 to 8 weeks (cm) Height will be measured in duplicate within .5cm.
Change in Acanthosis nigricans skin exam 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.
Change in Glucose Level Week 1 to week 8 (mg/dl) Measured by fasting blood samples
Change in Insulin Level Week 1 to week 8 (UIU/mL) Measured by fasting blood sample
Trial Locations
- Locations (1)
Children's Hospital of Los Angeles
🇺🇸Los Angeles, California, United States