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Clinical Trials/NCT01308710
NCT01308710
Completed
Phase 1

Endothelial Assessment of Risk From Lipids in Youth: Mediterranean Diet

University of California, San Francisco1 site in 1 country10 target enrollmentJanuary 2010
ConditionsHyperlipidemia

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Hyperlipidemia
Sponsor
University of California, San Francisco
Enrollment
10
Locations
1
Primary Endpoint
Endothelial function
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
July 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Endothelial function

Time Frame: Measured every 6 wks for 6 months

Study Sites (1)

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