Overview

This trial is active, not recruiting.

Conditions cardiovascular heart disease, metabolic syndrome
Treatments fish oil (bio-marine, pharma nord), n-6 pufa intake (margarine+sunflower oil vs. butter product+rapeseed oil)
Sponsor University of Copenhagen
Collaborator Danish Research Agency
Start date September 2005
End date April 2006
Trial size 60 participants
Trial identifier NCT00266292, IHE project no. A-304, KF 01 267804, SJVF 23-04-0050

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double-blind
Primary purpose prevention

Primary Outcomes

Measure
Fatty acid composition of PMBC - before and after 2 mo of interventions and after 2 mo of follow-up
time frame:
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
time frame:
Plasma CRP, IL-6 & fibrinogen - before, after and follow-up
time frame:
Plasma lipid profile: TAG, cholesterol, LDL & HDL - before, after and follow-up
time frame:
Blood pressure - before, after and follow-up
time frame:

Secondary Outcomes

Measure
Anthropometric measures - before, after & follow-up
time frame:
Ex vivo cytokine production in isolated monocytes - after intervention only
time frame:
Endothelial function (PWV and/or arterial compliance) - before & after
time frame:
Superoxide production in full blood samples - before & after
time frame:
Plasma insulin/glucose - before, after and follow-up
time frame:
Plasma markers of endothelial function (e.g. VCAM-1, ICAM-1, Matrix metallo proteinases, E- & P-selectin, nitrite and endothelin-1) - before and after
time frame:
Plasma CD40L - before, after and follow-up
time frame:
RBC fatty acid composition - before, after and follow-up
time frame:
Coagulation factors (e.g. PAI, tPA, factor VII) - before, after and follow-up
time frame:
Folate/homocysteine - before. after and follow-up
time frame:
Lipoprotein(a) - before, after and follow-up
time frame:

Eligibility Criteria

Male participants from 18 years up to 40 years old.

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:

Additional Information

Principal investigator Lotte Lauritzen, Ph.D
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2010.
Information provided to ClinicalTrials.gov by University of Copenhagen.