Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis

Not Applicable

Completed

• Conditions: Non-alcoholic Fatty-liver Disease
• Interventions: Dietary Supplement: Fructose Drink; Dietary Supplement: Glucose Drink

• Registration Number: NCT01188083
• Lead Sponsor: Emory University

Brief Summary

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.

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-08-23
• Study First Posted: 2010-08-25
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-20
• Last Update Posted: 2013-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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).

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fructose Drink	Fructose Drink	Subject will drink 3-8oz drinks per day for 4 weeks
Glucose Drink	Glucose Drink	Subject will drink 3-8oz drinks per day for 4 weeks

Primary Outcome Measures

Name	Time	Method
Hepatic Fat	2 & 4 Weeks

Secondary Outcome Measures

Name	Time	Method
Plasma Triglycerides	2 & 4 Weeks

Trial Locations

Locations (1)

Emory Children's Center; 🇺🇸 Atlanta, Georgia, United States