The Effects of a Mediterranean Diet in Pediatric Hyperlipidemia

Study Overview
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Brief Summary
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Children with high cholesterol levels are especially vulnerable and are at high risk for early onset coronary heart disease (CHD). Endothelial dysfunction, the earliest phase of CHD, is present in children with elevated cholesterol levels as early as 8 years of age. The long term objective of this study is to develop dietary interventions for the prevention and treatment of endothelial dysfunction in children with common lipid disorders including familial hypercholesterolemia (FH) and familial combined hyperlipidemia (FCH). Increasing evidence suggests that the Mediterranean diet and ω-3 fatty acids found in fish have cardioprotective effects. The specific aims of the study are to: determine whether a Mediterranean diet alone or combined with ω-3 fatty acid (eicosapentaenoic acid)improves endothelial function; evaluate the effects of the dietary interventions on lipids and lipoprotein subclasses; evaluate the effects of the dietary interventions on biomarkers for oxidative stress and inflammation. This study is a randomized, double-blind, placebo-controlled clinical trial that includes 34 children (ages 8-17) treated with the Mediterranean diet and ω-3 fatty acid supplements. A dietary educational behavioral intervention will be conducted over 6 months with individual counseling and group sessions. Endothelial function will be measured noninvasively by high resolution ultrasound of the brachial artery at baseline, 6, 12, 18 and 24 weeks. This study is unique because it is a new intervention designed for children at high risk for early CHD with a dietary component and supplementation with ω-3 fatty acids. If effective, this intervention would be broadly applicable in the community and lend valuable insight about dietary therapy to prevent the progression of CHD in hyperlipidemic children.

Official Title
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Endothelial Assessment of Risk From Lipids in Youth: Mediterranean Diet

Conditions
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Hyperlipidemia

Intervention / Treatment
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* Dietary Supplement: Omega-3 fatty acid (Eicosapentaenoic acid)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children (8-17 years old) Familial Hypercholesterolemia or Familial Combined Hyperlipidemia Able to read, write and understand English Parental consent and child assent Access to a computer and internet and literacy in the use of the internet The attendance of a parent to each educational session. Exclusion Criteria: Chronic systemic illness with or without secondary hyperlipidemia Current smoking

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 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

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Omega-3 fatty acid (Eicosapentaenoic acid)|1.0 grams daily for 6 weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function |  | Measured every 6 wks for 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endothelial function, lipids, pediatrics