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

Sponsor:	Penn State University
Collaborator:	Reliant Pharmaceuticals
Information provided by:	Penn State University
ClinicalTrials.gov Identifier:	NCT00504309

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:

MedlinePlus related topics: Diabetes Medicines Triglycerides

Drug Information available for: Docosahexaenoic acids Eicosapentaenoic acid Omacor

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):

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.

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 February 09, 2012