Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis

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

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