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The Effects of a Mediterranean Diet in Pediatric Hyperlipidemia

Endothelial Assessment of Risk From Lipids in Youth: Mediterranean Diet

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01308710
Acronym
EARLYMedit
Enrollment
10
Registered
2011-03-04
Start date
2010-01-31
Completion date
2011-07-31
Last updated
2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia

Keywords

endothelial function, lipids, pediatrics

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTOmega-3 fatty acid (Eicosapentaenoic acid)

1.0 grams daily for 6 weeks

Sponsors

Vanderbilt University
CollaboratorOTHER
Tufts University
CollaboratorOTHER
University of Guelph
CollaboratorOTHER
University of L'Aquila
CollaboratorOTHER
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Endothelial functionMeasured every 6 wks for 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026