NCT00266292

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

May 28, 2010

Status Verified

December 1, 2005

First QC Date

December 15, 2005

Last Update Submit

May 27, 2010

Conditions

Cardiovascular Heart DiseaseMetabolic Syndrome

Keywords

Fish oilPolyunsaturated fatty acidImmune functionEndothelial functionCardiovascular risk factors

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (11)

  • 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

  • +6 more secondary outcomes

Interventions

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

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Nutrition

Frederiksberg, DK-1958, Denmark

Location

Related Publications (4)

  • 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.

    PMID: 19494025RESULT

  • 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.

    PMID: 19000693RESULT

  • 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.

    PMID: 18492834RESULT

  • 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.

    PMID: 18199388RESULT

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Lotte Lauritzen, Ph.D

    Department of Human Nutrition, Royal Veterinary and Agricultural University, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 15, 2005

First Posted

December 16, 2005

Study Start

September 1, 2005

Study Completion

April 1, 2006

Last Updated

May 28, 2010

Record last verified: 2005-12

Locations

DK(1)