Effects of n3 LC PUFAs on Inflammatory, Immune and Senescence Features in Polyvascular Older Subj… (NCT06666101) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effects of n3 LC PUFAs on Inflammatory, Immune and Senescence Features in Polyvascular Older Subjects (OMSAGE)
80 participantsStarted 2024-11-04
Plain-language summary
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.
Who can participate
Age range
75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥ 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
* No illness or event within 2 months prior to inclusion (hospitalization, trauma, active cancer, infection, acute failure of chronic disease, surgical intervention)
* No history of multiple and/or severe allergies to drugs or foods
* No consumption of fish oil or omega-3 fatty acid supplements within 2 months prior to inclusion
* No consumption of more than 500 mg/day of dietary omega-3 fatty acids (questionnaire)
* No intake of anti-inflammatory or corticosteroid medication within 2 weeks prior to inclusion
* Able and authorized to take a pill
* No intervention planned in the months following the start of the study
Exclusion Criteria:
* Inflammatory syndrome (CRP \>10 mg/l) on day 0 and day 7
* Acute illness or event during the time of intervention
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Attenuation of production of inflammatory mediators