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

NCT06666101 | Not Yet Recruiting DMC

• 1 other identifier: B4062021000187
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Polyvascular Disease

Keywords

fatty acid, omega 3; immune response; inflammatory mediators; macrophage polarisation

Outcome Measures

Primary Outcomes (1)

• Attenuation of production of inflammatory mediators

  lowering plasma IL8 in pg/ml

  Day 0, Day 21

Secondary Outcomes (5)

• Enhanced production of proresolving mediators

  Day 0, Day 21

• Increased level of EPA and DHA

  Day 0, 4 hours post dose , Day 7, Day 21, Day 56

• Attenuation of production of senescence-associated secretory phenotype

  Day 0, Day 21

• Attenuation of production of inflammatory mediators from immune cells

  Day 0, Day 21

• Improving immune parameters

  Day 0, Day 7, Day 21, Day 51

Other Outcomes (1)

• Lowering features of senescence

  Day 0, Day 21

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Olive oil

Dietary Supplement: Placebo

Predominant EPA

ACTIVE COMPARATOR

4 capsules MorEPA plus (Minami Neslé) daily; 590 mg EPA (20:5 n-3) and 130 mg DHA (22:6 n-3)/gels Total: 2360 mg EPA + 520 mg DHA daily; Total in n-3: 2880 mg daily

Dietary Supplement: Long chain polyunsaturated Omega-3

Predominant DHA

ACTIVE COMPARATOR

4 capsules MorDHA (Minami Neslé) daily; 480 mg DHA (22:6 n-3) and 104 mg EPA (20:5 n-3)/gels Total: 1920 mg DHA + 416 mg EPA daily; Total in n-3: 2336 mg daily

Dietary Supplement: Long chain polyunsaturated Omega-3

EPA and DHA combined

ACTIVE COMPARATOR

2 capsules Mor DHA (total 1220 mg DHA) + 2 soft gels Mor EPA (total 1388 mg EPA): 2608 mg daily

Dietary Supplement: Long chain polyunsaturated Omega-3

Interventions

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

EPA and DHA combined; Predominant DHA; Predominant EPA

Placebo DIETARY_SUPPLEMENT

Olive oil

Placebo

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥ 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 history of multiple and/or severe allergies to drugs or foods
• No consumption of more than 500 mg/day of dietary omega-3 fatty acids (questionnaire)
• Able and authorized to take a pill
• No intervention planned in the months following the start of the study

You may not qualify if:

• Inflammatory syndrome (CRP \>10 mg/l) on day 0 and day 7
• Acute illness or event during the time of intervention

Sponsors & Collaborators

• Université Libre de Bruxelles: lead
• University of Mons: collaborator
• Université Catholique de Louvain: collaborator

Study Officials

• Karim Zouaoui Boudjeltia, PhD

  Laboratory of Experimental Medicine

  STUDY DIRECTOR

Central Study Contacts

Kéziah Korpak, Medical Doctor

CONTACT

003271921490; keziah.korpak@ulb.be

Karim Zouaoui Boudjeltia, PhD

CONTACT

003271924705; karim.zouaoui.boudjeltia@ulb.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Korpak Kéziah, medical doctor

Model Details: This is a randomized, controlled, double-blind, 2x2 factorial study among polyvascular subjects over 75 years of age (presence of two or more clinical locations of atherosclerosis) Patients were defined as having polyvascular disease in cases of vascular lesions in ≥2 disease territories or any combination of coronary, peripheral, or carotid artery disease according to the ROCKET AF trial. Coronary artery disease was defined as a history of percutaneous coronary intervention, myocardial infarction, or coronary artery bypass graft surgery. Peripheral artery disease was defined as intermittent amputation for arterial insufficiency, claudication, or a history of vascular reconstruction or bypass surgery. The presence of carotid stenosis was defined as a history of ≥50% stenosis in at least one carotid artery as defined on any imaging modality. A total of 80 participants will be studied (20 participants in each arm)

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 30, 2024
• Study Start: November 4, 2024
• Primary Completion: November 4, 2025
• Study Completion: December 31, 2025
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share