The Effects of a Mediterranean Diet in Pediatric Hyperlipidemia

Hyperlipidemia Clinical Trial

— EARLYMedit  

Official title:

Endothelial Assessment of Risk From Lipids in Youth: Mediterranean Diet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308710
• Other study ID #: R56NR004909
• Status: Completed
• Phase: Phase 1
• First received: March 3, 2011
• Last updated: January 23, 2014
• Start date: January 2010
• Est. completion date: July 2011

Study information

• Verified date: January 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Dietary Supplement:
• Omega-3 fatty acid (Eicosapentaenoic acid)
1.0 grams daily for 6 weeks

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Francisco	Tufts University, University of Guelph, University of L'Aquila, Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial function		Measured every 6 wks for 6 months	No