Clinical trial NCT00266292: The Effect of n-3 LCPUFA on Immune Function and Cardiovascular Risk Factors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Heart Disease
Metabolic Syndrome
Keywords: Fish oil
Polyunsaturated fatty acid
Immune function
Endothelial function
Cardiovascular risk factors
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Danish Research Agency
name: Hjerteforeningen
name: Technical University of Denmark
First posted: 2005-12-16
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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:

Primary outcomes:
measure: Fatty acid composition of PMBC - before and after 2 mo of interventions and after 2 mo of follow-up
measure: 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
measure: Plasma CRP, IL-6 & fibrinogen - before, after and follow-up
measure: Plasma lipid profile: TAG, cholesterol, LDL & HDL - before, after and follow-up
measure: Blood pressure - before, after and follow-up
Secondary outcomes:
measure: Anthropometric measures - before, after & follow-up
measure: Ex vivo cytokine production in isolated monocytes - after intervention only
measure: Endothelial function (PWV and/or arterial compliance) - before & after
measure: Superoxide production in full blood samples - before & after
measure: Plasma insulin/glucose - before, after and follow-up
measure: Plasma markers of endothelial function (e.g. VCAM-1, ICAM-1, Matrix metallo proteinases, E- & P-selectin, nitrite and endothelin-1) - before and after
measure: Plasma CD40L - before, after and follow-up
measure: RBC fatty acid composition - before, after and follow-up
measure: Coagulation factors (e.g. PAI, tPA, factor VII) - before, after and follow-up
measure: Folate/homocysteine - before. after and follow-up
measure: Lipoprotein(a) - before, after and follow-up
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Human Nutrition
Study officials:
affiliation: Department of Human Nutrition, Royal Veterinary and Agricultural University, Denmark
name: Lotte Lauritzen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.