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

Metabolic Syndrome Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00266292
• Other study ID #: KF 01 267804
• Secondary ID: SJVF 23-04-0050I
• Status: Active, not recruiting
• Phase: N/A
• First received: December 15, 2005
• Last updated: May 27, 2010
• Start date: September 2005
• Est. completion date: April 2006

Study information

• Verified date: December 2005
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Heart Disease
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Behavioral:
• Fish oil (Bio-Marine, Pharma Nord)

• n-6 PUFA intake (Margarine+sunflower oil vs. butter product+rapeseed oil)

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition	Frederiksberg

Sponsors (4)

Lead Sponsor	Collaborator
University of Copenhagen	Danish Research Agency, Hjerteforeningen, Technical University of Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (4)

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/S000711450 — View Citation

Damsgaard CT, Frøkiaer 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. — View Citation

Damsgaard CT, Lauritzen L, Calder PC, Kjaer TM, Frøkiaer 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 Me — View Citation

Damsgaard CT, Lauritzen L, Calder PC, Kjaer TR, Frøkiaer 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatty acid composition of PMBC - before and after 2 mo of interventions and after 2 mo of follow-up
Primary	Ex vivo cytokine production (e.g. IL-6, TNF-a, IL-10, and interferon-?) in whole blood and PBMC cultures after 24 h of stimulation - before and after interventions and after follow up
Primary	Plasma CRP, IL-6 & fibrinogen - before, after and follow-up
Primary	Plasma lipid profile: TAG, cholesterol, LDL & HDL - before, after and follow-up
Primary	Blood pressure - before, after and follow-up
Secondary	Anthropometric measures - before, after & follow-up
Secondary	Ex vivo cytokine production in isolated monocytes - after intervention only
Secondary	Endothelial function (PWV and/or arterial compliance) - before & after
Secondary	Superoxide production in full blood samples - before & after
Secondary	Plasma insulin/glucose - before, after and follow-up
Secondary	Plasma markers of endothelial function (e.g. VCAM-1, ICAM-1, Matrix metallo proteinases, E- & P-selectin, nitrite and endothelin-1) - before and after
Secondary	Plasma CD40L - before, after and follow-up
Secondary	RBC fatty acid composition - before, after and follow-up
Secondary	Coagulation factors (e.g. PAI, tPA, factor VII) - before, after and follow-up
Secondary	Folate/homocysteine - before. after and follow-up
Secondary	Lipoprotein(a) - before, after and follow-up