The Effect of n-3 LCPUFA on Immune Function and Cardiovascular Risk Factors
Primary Purpose
Cardiovascular Heart Disease, Metabolic Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Fish oil (Bio-Marine, Pharma Nord)
n-6 PUFA intake (Margarine+sunflower oil vs. butter product+rapeseed oil)
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Heart Disease focused on measuring Fish oil, Polyunsaturated fatty acid, Immune function, Endothelial function, Cardiovascular risk factors
Eligibility Criteria
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:
Sites / Locations
- Department of Human Nutrition
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00266292
First Posted
December 15, 2005
Last Updated
May 27, 2010
Sponsor
University of Copenhagen
Collaborators
Danish Research Agency, Hjerteforeningen, Technical University of Denmark
1. Study Identification
Unique Protocol Identification Number
NCT00266292
Brief Title
The Effect of n-3 LCPUFA on Immune Function and Cardiovascular Risk Factors
Study Type
Interventional
2. Study Status
Record Verification Date
December 2005
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Copenhagen
Collaborators
Danish Research Agency, Hjerteforeningen, Technical University of Denmark
4. Oversight
5. Study Description
Brief Summary
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
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Heart Disease, Metabolic Syndrome
Keywords
Fish oil, Polyunsaturated fatty acid, Immune function, Endothelial function, Cardiovascular risk factors
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Fish oil (Bio-Marine, Pharma Nord)
Intervention Type
Behavioral
Intervention Name(s)
n-6 PUFA intake (Margarine+sunflower oil vs. butter product+rapeseed oil)
Primary Outcome Measure Information:
Title
Fatty acid composition of PMBC - before and after 2 mo of interventions and after 2 mo of follow-up
Title
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
Title
Plasma CRP, IL-6 & fibrinogen - before, after and follow-up
Title
Plasma lipid profile: TAG, cholesterol, LDL & HDL - before, after and follow-up
Title
Blood pressure - before, after and follow-up
Secondary Outcome Measure Information:
Title
Anthropometric measures - before, after & follow-up
Title
Ex vivo cytokine production in isolated monocytes - after intervention only
Title
Endothelial function (PWV and/or arterial compliance) - before & after
Title
Superoxide production in full blood samples - before & after
Title
Plasma insulin/glucose - before, after and follow-up
Title
Plasma markers of endothelial function (e.g. VCAM-1, ICAM-1, Matrix metallo proteinases, E- & P-selectin, nitrite and endothelin-1) - before and after
Title
Plasma CD40L - before, after and follow-up
Title
RBC fatty acid composition - before, after and follow-up
Title
Coagulation factors (e.g. PAI, tPA, factor VII) - before, after and follow-up
Title
Folate/homocysteine - before. after and follow-up
Title
Lipoprotein(a) - before, after and follow-up
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lotte Lauritzen, Ph.D
Organizational Affiliation
Department of Human Nutrition, Royal Veterinary and Agricultural University, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Human Nutrition
City
Frederiksberg
ZIP/Postal Code
DK-1958
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
19494025
Citation
Damsgaard CT, Lauritzen L, Calder PC, Kjaer TR, Frokiaer H. Reduced ex vivo interleukin-6 production by dietary fish oil is not modified by linoleic acid intake in healthy men. J Nutr. 2009 Jul;139(7):1410-4. doi: 10.3945/jn.108.102269. Epub 2009 Jun 3.
Results Reference
result
PubMed Identifier
19000693
Citation
Damsgaard CT, Lauritzen L, Calder PC, Kjaer TM, Frokiaer H. Whole-blood culture is a valid low-cost method to measure monocytic cytokines - a comparison of cytokine production in cultures of human whole-blood, mononuclear cells and monocytes. J Immunol Methods. 2009 Jan 30;340(2):95-101. doi: 10.1016/j.jim.2008.10.005. Epub 2008 Nov 8.
Results Reference
result
PubMed Identifier
18492834
Citation
Damsgaard CT, Frokiaer H, Andersen AD, Lauritzen L. Fish oil in combination with high or low intakes of linoleic acid lowers plasma triacylglycerols but does not affect other cardiovascular risk markers in healthy men. J Nutr. 2008 Jun;138(6):1061-6. doi: 10.1093/jn/138.6.1061.
Results Reference
result
PubMed Identifier
18199388
Citation
Bartelt S, Timm M, Damsgaard CT, Hansen EW, Hansen HS, Lauritzen L. The effect of dietary fish oil-supplementation to healthy young men on oxidative burst measured by whole blood chemiluminescence. Br J Nutr. 2008 Jun;99(6):1230-8. doi: 10.1017/S0007114507853451. Epub 2008 Jan 17.
Results Reference
result
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The Effect of n-3 LCPUFA on Immune Function and Cardiovascular Risk Factors
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