Study [IFC-CNR-DEI] study / subjects / design / samples / assays

Basic properties of your study This page shows the basic information about your study, as well as information on the authorizations.

Publications

Contacts

  • Tullin, Mikkel
    Data Submission

Authorization

Public Design
Yes
Readers
rafcanali
Writers
rafcanali
Study title
DHA on Endothelial Inflammation (DEI)
Template
Intervention/Observation study
title
DHA on Endothelial Inflammation (DEI)
description
High intakes of n-3 fatty acids exert anti-inflammatory effects and cardiovascular protection, but the underlying molecular basis is incompletely defined. By genome-wide analysis we searched for novel effects of docosahexaenoic acid (DHA) on gene expression and pathways in human vascular endothelium under pro-inflammatory conditions.
code
IFC-CNR-DEI
startDate
2012-10-30 00:00:00.0
Study type
Human Intervention
Principle Investigator
Marika Massaro
Primary endpoint
To evaluate the effect of DHA on proinflammatory gene expression
Objectives
To evaluate the transcriptional effect of fish oil exposure on global gene expression regualtion as induced by proinflammatory cytokines
Central conclusion
DHA exert anti-inflammatory and anti-angiogenic activities in endothelial cells
Main health-related outcome
To evaluate the transcriptional effect of fish oil exposure on global gene expression regualtion as induced by proinflammatory cytokines
Exclusion criteria
• Not confluent or senescent cells
Inclusion criteria
• Cells within the sencond and fourth passage • Cells cobblestone-shaped • Cells positive to von Willebrand factor
Institute
Institute of Clinical Physiology of the National Research Council
Country (for multicentre study overall PI)
Italy
Consortium
not defined
Funding body
The study was supported by institutional funding by the Ministry of Instruction, University and Research - MIUR to RDC at “G. d’Annunzio” University, Chieti, Italy, and by the Italian Ministry of Health (Convenzione EINGE-MIUR (2000) art. 5.2, Convenzio
Clinicaltrials.gov or similar number
NA (not applicable)
Was the study approved by an ethics committee?
No
Ethical approval number
NA (not applicable)
Did the individuals providing data sign informed consent?
No
Study design
Parallel
Control group
Yes
Type of controls
Untreated cells
Randomisation
Yes
Full randomisation method (if any)
Computer random number generator
Blinding (yes/no)
No
Study terminated?
Yes
Compliance assessed?
Yes
Compliance assessment (for each treatment)
Evaluation of DHA incorporation into cell membrane
Factorial design?
Yes
Number of factors (for factorial designs only)
2
Total number of arms (Give number of distinct treatments in study)
4
Explanatory text (Give a textual account of the overall design leading to the total number of groups) or provide the study protocol.
Evaluation of the transcriptomics effects of the omega-3 fatty acid docosahexaenoic acid (DHA) in endothelial cells in basal condition as well as upon interleukin (IL)-1β challenge. Gene expression was examined using DNA microarray analysis on Agilent platform using 45,220 probes to interrogate 30,886 unique human genes and transcripts.
Treatments (Number and types of foods, drugs or other treatments compared)
Exposure to DHA (as obtained from fish oil) plus the pro-inflammatory cytokine interleukin(IL)-1.
Number of volunteers screened N(M:xx, F: xx)
NA (not applicable)
Number of volunteers enrolled N(M:xx, F: xx)
NA (not applicable)
Number of subjects (Male; Female)
NA (not applicable)
Follow-up planned
No

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