The Effect of n-3 LCPUFA on Immune Function and Cardiovascular Risk Factors
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00266292 |
|
Recruitment Status
: Unknown
Verified December 2005 by University of Copenhagen.
Recruitment status was: Active, not recruiting
First Posted
: December 16, 2005
Last Update Posted
: May 28, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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) | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | Double |
| Primary Purpose: | Prevention |
| Study Start Date : | September 2005 |
| Study Completion Date : | April 2006 |
- 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
- 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
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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:
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00266292
| Denmark | |
| Department of Human Nutrition | |
| Frederiksberg, Denmark, DK-1958 | |
| Principal Investigator: | Lotte Lauritzen, Ph.D | Department of Human Nutrition, Royal Veterinary and Agricultural University, Denmark |
Publications of Results:
| ClinicalTrials.gov Identifier: | NCT00266292 History of Changes |
| Other Study ID Numbers: |
KF 01 267804 SJVF 23-04-0050 IHE project no. A-304 |
| First Posted: | December 16, 2005 Key Record Dates |
| Last Update Posted: | May 28, 2010 |
| Last Verified: | December 2005 |
Keywords provided by University of Copenhagen:
|
Fish oil Polyunsaturated fatty acid Immune function Endothelial function Cardiovascular risk factors |
Additional relevant MeSH terms:
|
Heart Diseases Metabolic Syndrome X Cardiovascular Diseases Insulin Resistance |
Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |