Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
NCT Number: NCT03985020
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)
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Notify Me10 year–18 year
All sexes
Interventional
Not applicable
Los Angeles, California, 90027, United States
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
We will use commercially available stevia sweetened soft drink Zevia.
Bottled Water
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
Time frame: week 1 to 8 weeks (%)
Measured using DEXA
Time frame: week 1 to 8 weeks (kPA)
Measured using MR elastography (non-sedated study)
Time frame: week 1 to 8 weeks (cm)
Height will be measured in duplicate within .5cm.
Time frame: week 1 to 8 weeks (kg)
Measured using an electric scale.
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
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.
Time frame: week 1 to 8 weeks
measured by fasting blood sample
Time frame: Week 1 to week 8 (mg/dl)
Measured by fasting blood samples
Time frame: Week 1 to week 8 (UIU/mL)
Measured by fasting blood sample
Children's Hospital Los Angeles
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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