Non-alcoholic Fatty-liver Disease Clinical Trial
Official title:
Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis
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.
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
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)