Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00266292
Status:
UNKNOWN
Last Update Posted:
2010-05-28
First Post:
2005-12-15
Brief Title:
The Effect of n-3 LCPUFA on Immune Function and Cardiovascular Risk Factors
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2005-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IHE project no A-304 | None | None | None |
| SJVF 23-04-0050 | None | None | None |