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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by University of Copenhagen.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Danish Research Agency
Hjerteforeningen
Technical University of Denmark
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00266292
First received: December 15, 2005
Last updated: May 27, 2010
Last verified: December 2005
  Purpose

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


Condition Intervention
Cardiovascular Heart Disease
Metabolic Syndrome
Behavioral: Fish oil (Bio-Marine, Pharma Nord)
Behavioral: n-6 PUFA intake (Margarine+sunflower oil vs. butter product+rapeseed oil)

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

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

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

Estimated Enrollment: 60
Study Start Date: September 2005
Estimated Study Completion Date: April 2006
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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266292

Locations
Denmark
Department of Human Nutrition
Frederiksberg, Denmark, DK-1958
Sponsors and Collaborators
University of Copenhagen
Danish Research Agency
Hjerteforeningen
Technical University of Denmark
Investigators
Principal Investigator: Lotte Lauritzen, Ph.D Department of Human Nutrition, Royal Veterinary and Agricultural University, Denmark
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00266292     History of Changes
Other Study ID Numbers: KF 01 267804, SJVF 23-04-0050, IHE project no. A-304
Study First Received: December 15, 2005
Last Updated: May 27, 2010
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Copenhagen:
Fish oil
Polyunsaturated fatty acid
Immune function
Endothelial function
Cardiovascular risk factors

Additional relevant MeSH terms:
Metabolic Syndrome X
Heart Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014