NCT01188083CompletedNot Applicable
Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Emory University
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Hepatic Fat
Study Overview
Brief Summary
Primary Objectives:
- 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.
- 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.
- 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 11 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Fructose Drink
Experimental
Subject will drink 3-8oz drinks per day for 4 weeks
Intervention: Fructose Drink (Dietary Supplement)
Glucose Drink
Experimental
Subject will drink 3-8oz drinks per day for 4 weeks
Intervention: Glucose Drink (Dietary Supplement)
Outcomes
Primary Outcomes
Hepatic Fat
Time Frame: 2 & 4 Weeks
Secondary Outcomes
- Plasma Triglycerides(2 & 4 Weeks)
Investigators
Miriam Vos, MD
Principal Investigator
Emory University
Study Sites (1)
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