The Effects of a Mediterranean Diet in Pediatric Hyperlipidemia

NCT01308710 | Completed Phase 1 DMC

• 1 other identifier: R56NR004909
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

endothelial function; lipids; pediatrics

Outcome Measures

Primary Outcomes (1)

• Endothelial function

  Measured every 6 wks for 6 months

Interventions

Omega-3 fatty acid (Eicosapentaenoic acid) DIETARY_SUPPLEMENT

1.0 grams daily for 6 weeks

Also known as: PlusEPA

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Chronic systemic illness with or without secondary hyperlipidemia
• Current smoking

Sponsors & Collaborators

• University of California, San Francisco: lead
• Vanderbilt University: collaborator
• Tufts University: collaborator
• University of Guelph: collaborator
• University of L'Aquila: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Fatty Acids, Omega-3; Eicosapentaenoic Acid

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Eicosanoids

Study Officials

• Marguerite M. Engler, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Mary B. Engler, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: March 4, 2011
• Study Start: January 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 27, 2014

Record last verified: 2014-01

Locations

US (1)