The Effects of a Mediterranean Diet in Pediatric Hyperlipidemia



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:8 - 17
Updated:1/1/2014
Start Date:January 2010
End Date:August 2013
Contact:Marguerite M. Engler, PhD
Email:marguerite.engler@nih.gov
Phone:301-451-6175

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Endothelial Assessment of Risk From Lipids in Youth: Mediterranean Diet

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.


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
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1
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533 Parnassus Ave
San Francisco, California 94122
(415) 476-9000
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