Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 11 - 18 |
| Updated: | 11/23/2013 |
| Start Date: | June 2009 |
| End Date: | December 2012 |
| Contact: | Nicholas Raviele, BS |
| Email: | nicholas.raviele@emory.edu |
| Phone: | 4047273189 |
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, VLDL, 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 NAFLD 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
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