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OpenTrials
Completed

NCT Number: NCT01308710

The Effects of a Mediterranean Diet in Pediatric Hyperlipidemia

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.

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Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 fatty acid (Eicosapentaenoic acid)

Dietary Supplement

1.0 grams daily for 6 weeks

Other names: PlusEPA

Primary outcomes

  1. Endothelial function

    Time frame: Measured every 6 wks for 6 months

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Tufts University
  • University of Guelph
  • University of L'Aquila
  • Vanderbilt University

Registry information

Official study title

Endothelial Assessment of Risk From Lipids in Youth: Mediterranean Diet

Acronym: EARLYMedit

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 4, 2011
Registry last updated
Jan 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.