MedTrace Logo

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

NCT07761819 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1324

Last updated 2026-08-12

No results posted yet for this study

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.

Conditions

  • HIV - Human Immunodeficiency Virus

Interventions

DIETARY_SUPPLEMENT

The patients must ingest 50 mL of extra virgin olive oil daily

Cardiovascular risk analysis in HIV elder patients ingesting 50 mL of extra virgin olive oil daily

Sponsors & Collaborators

  • Fundacion SEIMC-GESIDA

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2031-06-15
Completion
2031-12-15

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07761819 on ClinicalTrials.gov