Non-Alcoholic Fatty Liver Disease
Conditions
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.
Interventions
OTHERStevia Intervention
We will use commercially available stevia sweetened soft drink Zevia.
OTHERWater Intervention
Bottled Water
Sponsors
Children's Hospital Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly assigned to one of three possible groups.
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 Weight | week 1 to 8 weeks (kg) | Measured using an electric scale. |
| 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 Fat percentage | week 1 to 8 weeks (%) | Measured using DEXA |
| Change in Triglyceride levels | week 1 to 8 weeks | measured by fasting blood sample |
| 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 |
| 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. |
Countries
United States
Outcome results
None listed