- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01188083
Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis (Sweet Bev)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory Children's Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Fructose Drink
Subject will drink 3-8oz drinks per day for 4 weeks
|
Fructose Based beverage 8 oz
|
EXPERIMENTAL: Glucose Drink
Subject will drink 3-8oz drinks per day for 4 weeks
|
Glucose Based beverage 8 oz per drink x 3 per day x 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hepatic Fat
Time Frame: 2 & 4 Weeks
|
2 & 4 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma Triglycerides
Time Frame: 2 & 4 Weeks
|
2 & 4 Weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00007471
- Emory-Vos-SweetBev (OTHER: Other)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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