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The Effect of n-3 LCPUFA on Immune Function and Cardiovascular Risk Factors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by University of Copenhagen.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Danish Research Agency
Hjerteforeningen
Technical University of Denmark
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00266292
First received: December 15, 2005
Last updated: May 27, 2010
Last verified: December 2005
History of Changes

December 15, 2005
May 27, 2010
September 2005
Not Provided
  • Fatty acid composition of PMBC - before and after 2 mo of interventions and after 2 mo of follow-up
  • Ex vivo cytokine production (e.g. IL-6, TNF-α, IL-10, and interferon-γ) in whole blood and PBMC cultures after 24 h of stimulation - before and after interventions and after follow up
  • Plasma CRP, IL-6 & fibrinogen - before, after and follow-up
  • Plasma lipid profile: TAG, cholesterol, LDL & HDL - before, after and follow-up
  • Blood pressure - before, after and follow-up
Same as current
Complete list of historical versions of study NCT00266292 on ClinicalTrials.gov Archive Site
  • Anthropometric measures - before, after & follow-up
  • Ex vivo cytokine production in isolated monocytes - after intervention only
  • Endothelial function (PWV and/or arterial compliance) - before & after
  • Superoxide production in full blood samples - before & after
  • Plasma insulin/glucose - before, after and follow-up
  • Plasma markers of endothelial function (e.g. VCAM-1, ICAM-1, Matrix metallo proteinases, E- & P-selectin, nitrite and endothelin-1) - before and after
  • Plasma CD40L - before, after and follow-up
  • RBC fatty acid composition - before, after and follow-up
  • Coagulation factors (e.g. PAI, tPA, factor VII) - before, after and follow-up
  • Folate/homocysteine - before. after and follow-up
  • Lipoprotein(a) - before, after and follow-up
  • Anthropometric measures - before, after & follow-up
  • Ex vivo cytokine production in isolated monocytes - after intervention only
  • Endothelial function (PWV and/or arterial compliance) - before & after
  • Superoxide production in full blood samples - before & after
  • Plasma insulin/glucose - before, after and follow-up
  • And if necessary funding is obtained:
  • Plasma markers of endothelial function (e.g. VCAM-1, ICAM-1, Matrix metallo proteinases, E- & P-selectin, nitrite and endothelin-1) - before and after
  • Plasma CD40L - before, after and follow-up
  • RBC fatty acid composition - before, after and follow-up
  • Coagulation factors (e.g. PAI, tPA, factor VII) - before, after and follow-up
  • Folate/homocysteine - before. after and follow-up
  • Lipoprotein(a) - before, after and follow-up
Not Provided
Not Provided
 
The Effect of n-3 LCPUFA on Immune Function and Cardiovascular Risk Factors
Not Provided

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

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
April 2006
Not Provided

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:
Male
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00266292
KF 01 267804, SJVF 23-04-0050, IHE project no. A-304
Not Provided
Not Provided
University of Copenhagen
  • Danish Research Agency
  • Hjerteforeningen
  • Technical University of Denmark
Principal Investigator: Lotte Lauritzen, Ph.D Department of Human Nutrition, Royal Veterinary and Agricultural University, Denmark
University of Copenhagen
December 2005

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