Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis
NCT ID: NCT01188083
Last Updated: 2013-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2009-06-30
2012-11-30
Brief Summary
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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
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
QUADRUPLE
Study Groups
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Fructose Drink
Subject will drink 3-8oz drinks per day for 4 weeks
Fructose Drink
Fructose Based beverage 8 oz
Glucose Drink
Subject will drink 3-8oz drinks per day for 4 weeks
Glucose Drink
Glucose Based beverage 8 oz per drink x 3 per day x 4 weeks
Interventions
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Fructose Drink
Fructose Based beverage 8 oz
Glucose Drink
Glucose Based beverage 8 oz per drink x 3 per day x 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
11 Years
18 Years
ALL
No
Sponsors
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Emory University
OTHER
Responsible Party
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Miriam Vos, MD
Principal Investigator
Principal Investigators
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Miriam Vos, Md
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory Children's Center
Atlanta, Georgia, United States
Countries
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References
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Holzberg JR, Jin R, Le NA, Ziegler TR, Brunt EM, McClain CJ, Konomi JV, Arteel GE, Vos MB. Plasminogen Activator Inhibitor-1 Predicts Quantity of Hepatic Steatosis Independent of Insulin Resistance and Body Weight. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):819-23. doi: 10.1097/MPG.0000000000001096.
Other Identifiers
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Emory-Vos-SweetBev
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00007471
Identifier Type: -
Identifier Source: org_study_id