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NCT01308710 · ClinicalTrials.gov registry record · Phase 1
The Effects of a Mediterranean Diet in Pediatric Hyperlipidemia
A Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT01308710 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 10 participants.
The verdict
NCT01308710, a Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study 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.
Interventions
- DIETARY_SUPPLEMENT Omega-3 fatty acid (Eicosapentaenoic acid)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2010-01 |
| Est. Completion | 2011-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01308710
The ClinicalTrials.gov registry entry for NCT01308710 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Omega-3 fatty acid (Eicosapentaenoic acid) is the first listed.
NCT01308710 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01308710 about?
NCT01308710 is a clinical study titled "The Effects of a Mediterranean Diet in Pediatric Hyperlipidemia". 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 s...
What is the current status of trial NCT01308710?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2010-01. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01308710?
The interventions under investigation include: Omega-3 fatty acid (Eicosapentaenoic acid) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01308710?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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