Effects of n3 LC PUFAs on Inflammatory, Immune and Senescence Features in Polyvascular Older Subjects (OMSAGE)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorUniversité Libre de Bruxelles

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 volunteers

Qualifiers

≥ 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

Design model

Factorial

Treatments tested in this trial

  • Long chain polyunsaturated Omega-3

    Dietary supplement

    2 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 supplement

    Olive oil

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: Predominant EPAActive comparator 1 intervention
Group C: Predominant DHAActive comparator 1 intervention
Group D: EPA and DHA combinedActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Attenuation of production of inflammatory mediators

lowering plasma IL8 in pg/ml

Time frame
Day 0, Day 21

Secondary outcomes

1

Enhanced production of proresolving mediators

Production of plasma proresolving mediators (plasma RvD1, RvE1, 17-HDHA, 18-HEPE LTB4 level in pg/ml plasma)

Time frame
Day 0, Day 21
2

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

Time frame
Day 0, 4 hours post dose , Day 7, Day 21, Day 56
3

Attenuation of production of senescence-associated secretory phenotype

lowering level of supernatant IL8 in pg/mL after incubation of serum with endothelial cells

Time frame
Day 0, Day 21
4

Attenuation of production of inflammatory mediators from immune cells

Lowering level of supernatant IL8 in pg/mL after stimulation of macrophage by calcium ionophore

Time frame
Day 0, Day 21

Other outcomes

1

Lowering features of senescence

Lowering marker senescence associated-β-galactosidase (SAβgal) mesured in % of activity on endothelial cells after incubation of serum

Time frame
Day 0, Day 21

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Université Libre de Bruxelles

Lead sponsor

University of Mons

Collaborator

Université Catholique de Louvain

Collaborator

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