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Sponsors and Collaborators: |
Penn State University Reliant Pharmaceuticals |
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Information provided by: | Penn State University |
ClinicalTrials.gov Identifier: | NCT00504309 |
The purpose of this study is to evaluate the cardiovascular and lipid effects of two doses of an omega-3 fatty acid concentrate in a group of people who normally are not treated for high lipids.
Condition | Intervention |
---|---|
Hypertriglyceridemia |
Drug: Omega-3 acid ethyl esters Other: Corn oil placebo |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Crossover Assignment, Efficacy Study |
Official Title: | Omacor: Measures of Endothelial Function and triGleride Alteration |
Enrollment: | 28 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
4 g P-OM3
|
Drug: Omega-3 acid ethyl esters
4 g P-OM3
|
2: Experimental
1 g P-OM3
|
Drug: Omega-3 acid ethyl esters
4 g P-OM3
|
3: Placebo Comparator |
Other: Corn oil placebo
4 g Placebo
|
Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Penn State University General Clinical Research Center | |
University Park, Pennsylvania, United States, 16802 |
Principal Investigator: | Sheila G West, PhD | Penn State University |
Principal Investigator: | Penny M Kris-Etherton, PhD | Penn State University |
Principal Investigator: | Ann C Skulas-Ray, B.S. | Penn State University |
Responsible Party: | Penn State University ( Sheila West, Ph.D. ) |
Study ID Numbers: | G214 |
Study First Received: | July 19, 2007 |
Last Updated: | June 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00504309 History of Changes |
Health Authority: | United States: Institutional Review Board |
triglycerides hypertriglyceridemia omega-3 n-3 eicosapentaenoic acid EPA |
docosahexaenoic acid DHA flow mediated dilation fish Moderate hypertriglyceridemia |
Metabolic Diseases Hyperlipidemias Hypertriglyceridemia Dilatation, Pathologic |
Omega 3 Fatty Acid Metabolic Disorder Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Hyperlipidemias Hypertriglyceridemia Dyslipidemias Lipid Metabolism Disorders |