Not Yet RecruitingNot Applicable

Effect of Extra Virgin Olive Oil Consumption on the Occurrence of Cardiovascular Events in Population Living With HIV

Spain1,324 participantsStarted 2026-10-31

Plain-language summary

Study Summary: OLEUM VIHTAEGeneral Information Sponsor: Fundación SEIMC - GESIDA Study Title: Effect of Extra Virgin Olive Oil (EVOO) consumption on the occurrence of cardiovascular events in people living with HIV. Protocol Code: GESIDA 12725 (Version 2.0, Jan 13, 2026) Study Design: National, multicenter, randomized, open-label clinical trial. Intervention Product: Extra Virgin Olive Oil (EVOO). Estimated Enrollment: 1,324 participants (662 per arm). Study Duration: Approximately 60 months (5 years) per participant. Objectives Primary Objective: To analyze the incidence of a composite index of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE), including acute coronary syndrome, peripheral arterial disease, coronary/cerebral/peripheral revascularization, cerebrovascular disease, and cardiovascular or cerebrovascular death. Secondary Objectives: Incidence of individual cardiovascular events (Stroke, TIA, Heart Failure, Atrial Fibrillation). All-cause and cardiovascular mortality. Changes in metabolic and physical parameters (weight, blood pressure, glucose, lipid profile). Development of new comorbidities (HTA, DM2, Obesity) and initiation of related treatments. Exploratory sub-studies: Changes in gut microbiota, epigenetic aging markers, inflammation panels (96 cytokines), and urinary hydroxytyrosol levels. Study Population Key Inclusion Criteria: HIV-1 infected individuals (diagnosed ≥ 1 year). Age: 50 to 75 years. On Antiretroviral Therapy (ART) ≥ 1 year with suppressed viral load (\<50 copies/mL) for at least 6 months. Presence of at least one cardiovascular risk factor (HTA, DM2, high LDL, low HDL, smoking, or family history). Willingness to modify diet and no intolerance to EVOO. Key Exclusion Criteria: Pre-existing ischemic heart disease, cerebrovascular disease, or peripheral arterial disease. Calculated cardiovascular risk (RV10 ASCVD) \< 5%. Life expectancy \< 1 year or inability to complete the study. Severe comorbidities: Stage C Cirrhosis, end-stage renal failure, dementia, or active malignancy. Current high EVOO intake (≥30 mL/daily). Treatment Plan Participants will be randomized (1:1 ratio) into two groups: EVOO Group: Daily intake of 50 mL of Extra Virgin Olive Oil. Control Group: Continuation of their usual diet (verified as not rich in EVOO). Statistical Analysis \& Monitoring Primary Endpoint: Proportion of patients meeting the composite cardiovascular morbidity/mortality index at 5 years. Methodology: Analysis by protocol and intention-to-treat (ITT) using SPSS v28. Generalized linear models for repeated measures, adjusted for covariates. Interim Analysis: Planned for Year 2 and Year 4. Ethics Board (Board Affiliation): CEIm Hospital Costa del Sol, Marbella, Spain.

Who can participate

Age range

50 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: * HIV-1 infection with at least one year since diagnosis * Ability to sign the informed consent form * Age between 50 and 75 years (including those who have already turned 50 and those under 76) at the time of signing the informed consent form * ART for at least one year, with a viral load \<50 copies/mL for at least the last year, or elite controller (Western Blot serology + with viral loads \<50 copies/mL in the absence of ART) * HIV-1 viral load ≤50 copies/mL for at least 6 months prior to signing the consent form. If the viral load is \>50 copies/mL at the baseline visit, the participant will not be excluded and the investigator will act in accordance with standard clinical practice. * If in the previous 6 months the participant has had an isolated viral load of \<200 copies/mL with another subsequent viral load \<50 copies/mL, entry into the trial will be accepted provided that in the 12 months prior to entry into the trial there was only one isolated detectable determination. * No reported intolerance to EVOO * Willingness to change diet * Presence of at least one of the following risk factors: hypertension, DM2, high LDL cholesterol, low HDL, high lipoprotein (a), tobacco use, first-degree family history of early cardiovascular disease (\<55 years in men or \<65 years in women) Exclusion Criteria: * Presence of ischemic heart disease, cerebrovascular disease, or peripheral arterial disease in any form. * Cardiovascular risk calculated by ASCVD VR…

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

Proportion of participants with a major cardiovascular event or cardiovascular/cerebrovascular death

Timeframe: From randomization until the first occurrence of a component of the composite outcome or the end of study follow-up, assessed up to 5 years.

Trial details

NCT IDNCT07761819

SponsorFundacion SEIMC-GESIDA

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-06-15

Contact for this trial

Julián Olalla

034951293854 julio.olalla@gmail.com

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