The Effects of a Mediterranean Diet in Pediatric Hyperlipidemia (EARLYMedit)

January 23, 2014 updated by: University of California, San Francisco

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endothelial function
Time Frame: Measured every 6 wks for 6 months
Measured every 6 wks for 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

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

Investigators

  • Principal Investigator: Marguerite M. Engler, PhD, University of California, San Francisco
  • Principal Investigator: Mary B. Engler, PhD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

March 3, 2011

First Submitted That Met QC Criteria

March 3, 2011

First Posted (ESTIMATE)

March 4, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 27, 2014

Last Update Submitted That Met QC Criteria

January 23, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R56NR004909

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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