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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014