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Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis

NCT01188083 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2013-11-21

No results posted yet for this study

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.

Conditions

  • Non-alcoholic Fatty-liver Disease

Interventions

DIETARY_SUPPLEMENT

Fructose Drink

Fructose Based beverage 8 oz

DIETARY_SUPPLEMENT

Glucose Drink

Glucose Based beverage 8 oz per drink x 3 per day x 4 weeks

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Miriam Vos, Md · Emory University

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
11 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01188083 on ClinicalTrials.gov