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

This study has been completed.
Sponsor:
Collaborators:
Vanderbilt University
Tufts University
University of Guelph
University of L'Aquila
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01308710
First received: March 3, 2011
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Hyperlipidemia
Dietary Supplement: Omega-3 fatty acid (Eicosapentaenoic acid)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Endothelial Assessment of Risk From Lipids in Youth: Mediterranean Diet

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Endothelial function [ Time Frame: Measured every 6 wks for 6 months ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: January 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Omega-3 fatty acid (Eicosapentaenoic acid)
    1.0 grams daily for 6 weeks
    Other Name: PlusEPA
  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308710

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Vanderbilt University
Tufts 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
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01308710     History of Changes
Other Study ID Numbers: R56NR004909
Study First Received: March 3, 2011
Last Updated: January 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
endothelial function
lipids
pediatrics

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 30, 2014