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

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.