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Vascular and Lipid Effects of Omega-3 Fatty Acids in People With Moderately Elevated Triglycerides (OMEGA)

This study has been completed.
Sponsor:
Collaborator:
Reliant Pharmaceuticals
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00504309
First received: July 19, 2007
Last updated: July 14, 2010
Last verified: June 2008
History of Changes
  Purpose

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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Omacor: Measures of Endothelial Function and triGleride Alteration

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Triglyceride levels and lipid profile [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Erythrocyte fatty acids [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Flow-mediated dilation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Cardiovascular reactivity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Circulating Inflammatory Markers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Fasting Insulin and glucose [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Psychosocial profile [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: July 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
4 g P-OM3
 Drug: Omega-3 acid ethyl esters
4 g P-OM3
Experimental: 2
1 g P-OM3
 Drug: Omega-3 acid ethyl esters
4 g P-OM3
Placebo Comparator: 3 Other: Corn oil placebo
4 g Placebo

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • triglycerides 150-500 mg/dL
  • aged 21-65
  • generally healthy
  • BMI 20-39

Exclusion Criteria:

  • smoking
  • premenopausal (if female)
  • use of hormone replacement or oral contraceptives
  • use of lipid lowering or blood pressure medication
  • hypertension (BP > 150/95)
  • peripheral vascular disease
  • heart disease, diabetes, or stroke
  • inflammatory disease (e.g. rheumatoid arthritis or crohn's)
  • elevated liver enzymes
  • high intake of omega-3 containing foods
  • allergy to adhesive or latex
  • use of aspirin, anticoagulants, or SSRI
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504309

Locations
United States, Pennsylvania
Penn State University General Clinical Research Center
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
Reliant Pharmaceuticals
Investigators
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
  More Information

No publications provided by Penn State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sheila West, Ph.D., Penn State University
ClinicalTrials.gov Identifier: NCT00504309     History of Changes
Other Study ID Numbers: G214
Study First Received: July 19, 2007
Last Updated: July 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
triglycerides
hypertriglyceridemia
omega-3
n-3
eicosapentaenoic acid
EPA
 docosahexaenoic acid
DHA
flow mediated dilation
fish
Moderate hypertriglyceridemia

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 17, 2013