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

May 27, 2010 updated by: University of Copenhagen
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg, Denmark, DK-1958
        • Department of Human Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Danish Research Agency
Technical University of Denmark
Hjerteforeningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion

April 1, 2006

Study Registration Dates

First Submitted

December 15, 2005

First Submitted That Met QC Criteria

December 15, 2005

First Posted (ESTIMATE)

December 16, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

May 28, 2010

Last Update Submitted That Met QC Criteria

May 27, 2010

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KF 01 267804
  • SJVF 23-04-0050
  • IHE project no. A-304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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