University of California, San Francisco
San Francisco, California, 94143, United States
NCT Number: NCT01308710
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.
Looking for future studies?
Notify Me8 year–17 year
All sexes
Interventional
Phase 1
San Francisco, California, 94143, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1.0 grams daily for 6 weeks
Other names: PlusEPA
Time frame: Measured every 6 wks for 6 months
University of California, San Francisco
Other
Endothelial Assessment of Risk From Lipids in Youth: Mediterranean Diet
Acronym: EARLYMedit
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07710898
Diabete Mellitus, Diabetes Mellitus
Lahore, Pakistan
View Trial DetailsNCT07696559
Dyslipidemias, Hyperlipidemia
Lahore, Pakistan
View Trial DetailsNCT00001154
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Dyslipidemia
Bethesda, Maryland, United States
View Trial DetailsNCT01212159
Dyslipidemias, Hyperlipidemia
Philadelphia, Pennsylvania, United States
View Trial Details