Non-alcoholic Fatty-liver Disease
Conditions
Keywords
NASH, non-alcoholic fatty-liver disease, Hispanic, overweight
Brief summary
Primary Objectives: 1. To determine whether a 4 week reduction in dietary fructose intake improves hepatic steatosis in overweight children who have a baseline high fructose consumption and hepatic steatosis. 2. To determine if a 4 week reduction of dietary fructose improves fasting plasma triglycerides, free fatty acids, very low-density lipoprotein, insulin and glucose as well as post-prandial levels in response to a high fructose meal. 3. To determine if a 4 week reduction of dietary fructose improves markers of oxidative stress. Study Design: A blinded randomized study comparing glucose beverages to isocaloric fructose beverages administered over 4 weeks.
Detailed description
Planned Sample Size: Phase 1) 96 subjects Phase 2) 40 subjects Patient Population: Overweight Hispanic children with non-alcoholic fatty-liver disease age 11 to 18 years who are stable and not taking any chronic medication with no recent acute illnesses. Definitions: * BMI \>95th %tile for age and gender * Self-identified as Hispanic/Latino * Baseline hepatic fat fraction \> 10% (Have nonalcoholic fatty liver disease) * Sweetened beverage intake of at least 24 ounces/day
Interventions
DIETARY_SUPPLEMENTFructose Drink
Fructose Based beverage 8 oz
DIETARY_SUPPLEMENTGlucose Drink
Glucose Based beverage 8 oz per drink x 3 per day x 4 weeks
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* BMI \> 85th %tile * Self identified as Hispanic * Age 11-18 years * Baseline hepatic fat fraction \>8% * Self reported sugar beverage intake of at least 24 oz (equivalent to 3 sugar sweetened drinks per day).
Exclusion criteria
* Currently attempting weight gain or weight loss * Cirrhosis visible on baseline MRI * Renal insufficiency found on screening labs (creatinine \> 2) * Recent acute illness within past 4 weeks (defined by fever \> 100.4ºF) * Pregnancy * Chronic illness requiring medication including diabetes * Fasting glucose \>120 on screening labs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepatic Fat | 2 & 4 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Plasma Triglycerides | 2 & 4 Weeks |
Countries
United States
Outcome results
None listed