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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-04-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Cardiovascular Heart Disease Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Fish oil (Bio-Marine, Pharma Nord)

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes