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Cardiovascular Heart DiseaseNCT00266292

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

A study testing Fish oil (Bio-Marine, Pharma Nord) and n-6 PUFA intake (Margarine+sunflower oil vs. butter product+rapeseed oil) in people with Cardiovascular Heart Disease and Metabolic Syndrome, run by University of Copenhagen at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
What is being tested?
Fish oil (Bio-Marine, Pharma Nord) and n-6 PUFA intake (Margarine+sunflower oil vs. butter product+rapeseed oil)
How many people
60 participants
Where
1 siteDenmark
Study dates
Sep 2005to Apr 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Human Nutrition

    Frederiksberg, DK-1958

Other trials in Denmark

About this study

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

Read the 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.

Being tested
Fish oil (Bio-Marine, Pharma Nord), n-6 PUFA intake (Margarine+sunflower oil vs. butter product+rapeseed oil)
Keywords
Fish oil, Polyunsaturated fatty acid, Immune function, Endothelial function, Cardiovascular risk factors
Medical subject headings
Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fish oil (Bio-Marine, Pharma Nord)Behavioural

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fatty acid composition of PMBC - before and after 2 mo of interventions and after 2 mo of follow-up

  2. 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

  3. Plasma CRP, IL-6 & fibrinogen - before, after and follow-up

  4. Plasma lipid profile: TAG, cholesterol, LDL & HDL - before, after and follow-up

  5. Blood pressure - before, after and follow-up

Secondary outcomes (11)

  1. Anthropometric measures - before, after & follow-up

  2. Ex vivo cytokine production in isolated monocytes - after intervention only

  3. Endothelial function (PWV and/or arterial compliance) - before & after

  4. Superoxide production in full blood samples - before & after

  5. Plasma insulin/glucose - before, after and follow-up

  6. Plasma markers of endothelial function (e.g. VCAM-1, ICAM-1, Matrix metallo proteinases, E- & P-selectin, nitrite and endothelin-1) - before and after

  7. Plasma CD40L - before, after and follow-up

  8. RBC fatty acid composition - before, after and follow-up

  9. Coagulation factors (e.g. PAI, tPA, factor VII) - before, after and follow-up

  10. Folate/homocysteine - before. after and follow-up

  11. Lipoprotein(a) - before, after and follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2005 (estimated)
  2. Study startSep 2005
  3. Study completionApr 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Enrolment
60 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00266292
Sponsor's protocol ID
KF 01 267804
Other IDs
SJVF 23-04-0050, IHE project no. A-304
Status last verified
Dec 2005
First submitted
15 Dec 2005
Last updated
28 May 2010
Results posted
No

Publications

  • Damsgaard CT, Lauritzen L, Calder PC, Kjaer TR, Frokiaer H. Reduced ex vivo interleukin-6 production by dietary fish oil is not modified by linoleic acid intake in healthy men. J Nutr. 2009 Jul;139(7):1410-4. doi: 10.3945/jn.108.102269. Epub 2009 Jun 3.

    PubMed 19494025

  • Damsgaard CT, Lauritzen L, Calder PC, Kjaer TM, Frokiaer H. Whole-blood culture is a valid low-cost method to measure monocytic cytokines - a comparison of cytokine production in cultures of human whole-blood, mononuclear cells and monocytes. J Immunol Methods. 2009 Jan 30;340(2):95-101. doi: 10.1016/j.jim.2008.10.005. Epub 2008 Nov 8.

    PubMed 19000693

  • Damsgaard CT, Frokiaer H, Andersen AD, Lauritzen L. Fish oil in combination with high or low intakes of linoleic acid lowers plasma triacylglycerols but does not affect other cardiovascular risk markers in healthy men. J Nutr. 2008 Jun;138(6):1061-6. doi: 10.1093/jn/138.6.1061.

    PubMed 18492834

  • Bartelt S, Timm M, Damsgaard CT, Hansen EW, Hansen HS, Lauritzen L. The effect of dietary fish oil-supplementation to healthy young men on oxidative burst measured by whole blood chemiluminescence. Br J Nutr. 2008 Jun;99(6):1230-8. doi: 10.1017/S0007114507853451. Epub 2008 Jan 17.

    PubMed 18199388

Questions about this trial

What is this clinical trial studying?

A study testing Fish oil (Bio-Marine, Pharma Nord) and n-6 PUFA intake (Margarine+sunflower oil vs. butter product+rapeseed oil) in people with Cardiovascular Heart Disease and Metabolic Syndrome, run by University of Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fatty acid composition of PMBC - before and after 2 mo of interventions and after 2 mo of follow-up. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00266292, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2010.

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