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

University of Copenhagen logo

University of Copenhagen

Status

Unknown

Conditions

Cardiovascular Heart Disease
Metabolic Syndrome

Treatments

Behavioral: Fish oil (Bio-Marine, Pharma Nord)
Behavioral: n-6 PUFA intake (Margarine+sunflower oil vs. butter product+rapeseed oil)

Study type

Interventional

Funder types

Other

Identifiers

NCT00266292
KF 01 267804
IHE project no. A-304
SJVF 23-04-0050

Details and patient eligibility

About

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

Full 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.

Sex

Male

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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:

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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