About this trial
The objectives is to evaluate the effect of omega-3 fatty acids in old participants with polyvascular disease on immune parameters and inflammatory mediators at different times. Three modalities of administration of omega-3 will be compared with a placebo (olive oil): predominant EPA (Eicosapentaenoic acid), predominant DHA (doxosahexaenoic acid), and combinaison of both. This study will measure the level of omega3 fatty acids in this population 4 hours after taking, on the 7th day, on the 21th day of administration and 1 month after administration.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 75 years old
Patients with polyvascular disease in cases of vascular lesions in ≥2 disease territories or any combination of coronary, peripheral, or carotid artery disease.
Able to comply with the requirements of the study protocol
Signed informed consent form approved by the ethical committee
Disqualifiers
Inflammatory syndrome (CRP >10 mg/l) on day 0 and day 7
Acute illness or event during the time of intervention
Trial design
Factorial
Treatments tested in this trial
Long chain polyunsaturated Omega-3
Dietary supplement2 capsules of fatty acids in the morning and 2 capsules in the evening except the first day, 4 soft gels in a single administration in the morning, ± 2,6 g/d
Placebo
Dietary supplementOlive oil
Treatment groups
Trial outcomes
Primary outcomes
Attenuation of production of inflammatory mediators
lowering plasma IL8 in pg/ml
Secondary outcomes
Enhanced production of proresolving mediators
Production of plasma proresolving mediators (plasma RvD1, RvE1, 17-HDHA, 18-HEPE LTB4 level in pg/ml plasma)
Increased level of EPA and DHA
To measure the level of omega-3 in this population 4 hours after consumption (kinetics), on the 7th day of administration, on the 21st day and 1 month after administration (plasma EPA, DHA and AA level in pg/ml) and improved Omega6/3 ratio
Attenuation of production of senescence-associated secretory phenotype
lowering level of supernatant IL8 in pg/mL after incubation of serum with endothelial cells
Attenuation of production of inflammatory mediators from immune cells
Lowering level of supernatant IL8 in pg/mL after stimulation of macrophage by calcium ionophore
Other outcomes
Lowering features of senescence
Lowering marker senescence associated-β-galactosidase (SAβgal) mesured in % of activity on endothelial cells after incubation of serum
Locations
Sponsors and contacts
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Université Libre de Bruxelles
Lead sponsor
University of Mons
Collaborator
Université Catholique de Louvain
Collaborator
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