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

Tracking Information

First Received Date ^ICMJE

July 19, 2007

Last Updated Date

July 14, 2010

Start Date ^ICMJE

July 2007

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Triglyceride levels and lipid profile [ Time Frame: 8 weeks ]
Erythrocyte fatty acids [ Time Frame: 8 weeks ]
Flow-mediated dilation [ Time Frame: 8 weeks ]
Cardiovascular reactivity [ Time Frame: 8 weeks ]

Change History

Complete list of historical versions of study NCT00504309 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Circulating Inflammatory Markers [ Time Frame: 8 weeks ]
Fasting Insulin and glucose [ Time Frame: 8 weeks ]
Psychosocial profile [ Time Frame: 8 weeks ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Omacor: Measures of Endothelial Function and triGleride Alteration

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science

Condition ^ICMJE

Hypertriglyceridemia

Intervention ^ICMJE

Drug: Omega-3 acid ethyl esters
4 g P-OM3
Other: Corn oil placebo
4 g Placebo

Study Arm (s)

Experimental: 1
4 g P-OM3

Intervention: Drug: Omega-3 acid ethyl esters
Experimental: 2
1 g P-OM3

Intervention: Drug: Omega-3 acid ethyl esters
Placebo Comparator: 3
Intervention: Other: Corn oil placebo

Publications *

Skulas-Ray AC, Kris-Etherton PM, Harris WS, Vanden Heuvel JP, Wagner PR, West SG. Dose-response effects of omega-3 fatty acids on triglycerides, inflammation, and endothelial function in healthy persons with moderate hypertriglyceridemia. Am J Clin Nutr. 2011 Feb;93(2):243-52. Epub 2010 Dec 15.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00504309

Other Study ID Numbers ^ICMJE

G214

Has Data Monitoring Committee

Responsible Party

Sheila West, Ph.D., Penn State University

Study Sponsor ^ICMJE

Penn State University

Collaborators ^ICMJE

Reliant Pharmaceuticals

Investigators ^ICMJE

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

Information Provided By

Penn State University

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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