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Sponsors and Collaborators: |
University of Copenhagen The Danish Research Agency Hjerteforeningen Techinical University of Denmark |
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Information provided by: | University of Copenhagen |
ClinicalTrials.gov Identifier: | NCT00266292 |
The purpose of this study is to investigate the effects of long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFA) on immune function and cardiovascular disease risk
Condition | Intervention |
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Cardiovascular Heart Disease Metabolic Syndrome |
Behavioral: Fish oil (Bio-Marine, Pharma Nord) Behavioral: n-6 PUFA intake (Margarine+sunflower oil vs. butter product+rapeseed oil) |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study |
Estimated Enrollment: | 60 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | April 2006 |
In a controlled, double-blinded human intervention study the effects of fish oil versus control (olive oil) and of a high versus low consumption of n-6 polyunsaturated fatty acids are investigated. Sixty-seventy healthy men will be randomized to oil capsules and to substitute their dietary fats with one of two types of oil and butter-product that we provide. Outcome variables are ex vivo cytokine production in full blood and isolated immune cells after 24 h of stimulation with bacteria or bacterial components, blood pressure and arterial function, plasma concentrations of cholesterol, triacylglycerol, C-reactive protein and a number of other markers of endothelial function and cardiovascular risk.
The hypotheses are that both increased intake of n-3 polyunsaturated fatty acids (from fish oil) and a low consumption of n-6 polyunsaturated fatty acids increase incorporation of docosahexanoic acid in immune cell membranes and that this decreases the inflammatory response and potential and improve overall cardiovascular disease risk.
The mechanistic aspects of this will be further explored by in vitro studies with monocytes cultured in the presence of varying amounts of polyunsaturated fatty acids.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Healthy (no chronic diseases and no regular medications), BMI >18.5 and <27.5 kg/m2, Daily use of fats and home cooking >5 d/wk, Heavy exercise <7 h/wk, Not daily smokers (<5 cigarets/wk)
Exclusion Criteria:
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Denmark | |
Department of Human Nutrition | |
Frederiksberg, Denmark, DK-1958 |
Principal Investigator: | Lotte Lauritzen, Ph.D | Department of Human Nutrition, Royal Veterinary and Agricultural University, Denmark |
Study ID Numbers: | KF 01 267804, SJVF 23-04-0050, IHE project no. A-304 |
Study First Received: | December 15, 2005 |
Last Updated: | August 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00266292 |
Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
Fish oil Polyunsaturated fatty acid Immune function Endothelial function Cardiovascular risk factors |
Heart Diseases |
Pathologic Processes Disease Syndrome Cardiovascular Diseases |