The Effects of a Mediterranean Diet in Pediatric Hyperlipidemia

NCT ID: NCT01308710

Last Updated: 2014-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-07-31

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.

Conditions

Hyperlipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Interventions

Omega-3 fatty acid (Eicosapentaenoic acid)

1.0 grams daily for 6 weeks

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

PlusEPA

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: collaborator

University of Guelph

OTHER

Sponsor Role: collaborator

University of L'Aquila

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marguerite M. Engler, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Mary B. Engler, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

R56NR004909

Identifier Type: -

Identifier Source: org_study_id