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.
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)
Presence of ischemic heart disease, cerebrovascular disease, or peripheral arterial disease in any form.
Cardiovascular risk calculated by ASCVD VR10 less than 5%.
Life expectancy of less than one year in the investigator's opinion.
Inability to complete the study in the investigator's opinion.