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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00504309
Recruitment Status : Completed
First Posted : July 20, 2007
Last Update Posted : July 15, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Hypertriglyceridemia Drug: Omega-3 acid ethyl esters Other: Corn oil placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Omacor: Measures of Endothelial Function and triGleride Alteration
Study Start Date : July 2007
Primary Completion Date : January 2009
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Triglyceride levels and lipid profile [ Time Frame: 8 weeks ]
  2. Erythrocyte fatty acids [ Time Frame: 8 weeks ]
  3. Flow-mediated dilation [ Time Frame: 8 weeks ]
  4. Cardiovascular reactivity [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Circulating Inflammatory Markers [ Time Frame: 8 weeks ]
  2. Fasting Insulin and glucose [ Time Frame: 8 weeks ]
  3. Psychosocial profile [ Time Frame: 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: July 20, 2007    Key Record Dates
Last Update Posted: July 15, 2010
Last Verified: June 2008

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