Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis

Study Overview
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Brief Summary
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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
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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

Official Title
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Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis

Conditions
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Non-alcoholic Fatty-liver Disease

Intervention / Treatment
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* Dietary Supplement: Fructose Drink
* Dietary Supplement: Glucose Drink


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fructose Drink<br>Subject will drink 3-8oz drinks per day for 4 weeks | Dietary Supplement: Fructose Drink<br>* Fructose Based beverage 8 oz<br>|
| Experimental: Glucose Drink<br>Subject will drink 3-8oz drinks per day for 4 weeks | Dietary Supplement: Glucose Drink<br>* Glucose Based beverage 8 oz per drink x 3 per day x 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic Fat |  | 2 & 4 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Triglycerides |  | 2 & 4 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NASH, non-alcoholic fatty-liver disease, Hispanic, overweight