An interventional study of The patients must ingest 50 mL of extra virgin olive oil daily in HIV - Human Immunodeficiency Virus, sponsored by Fundacion SEIMC-GESIDA. Not yet recruiting at 1 site in Spain. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Fundacion SEIMC-GESIDA · Not applicable, Interventional, and Other
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.
Cardiovascular diseases and inflammatory conditions are major contributors to morbidity and mortality. Extra virgin olive oil (EVOO) is a dietary component rich in bioactive compounds, including polyphenols, which have been associated with anti-inflammatory, antioxidant and cardiometabolic effects.
OLEUM VIHTAE is a multicenter research project designed to evaluate the potential impact of extra virgin olive oil supplementation in hospitalized patients. The study will assess clinical outcomes and biological parameters associated with inflammation and disease progression.
Participants will receive extra virgin olive oil according to the study protocol during the intervention period. Clinical, epidemiological and laboratory data will be collected to investigate the relationship between EVOO administration and patient outcomes.
The results of this study may contribute to a better understanding of the potential role of EVOO as a nutritional strategy to modulate inflammatory responses and improve clinical outcomes in hospitalized patients.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's planned enrollment of 1,324 is above the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Fundacion SEIMC-GESIDA is the lead sponsor of 30 studies on the registry; 2 are open to participants now.
Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patients enrolled in this arm must ingest 50 mL of extra virgin olive oil daily
Dietary Supplement: The patients must ingest 50 mL of extra virgin olive oil daily
No Intervention
Cardiovascular risk analysis in HIV elder patients ingesting 50 mL of extra virgin olive oil daily
Proportion of participants with a major cardiovascular event or cardiovascular/cerebrovascular death
Proportion of participants who experience a composite cardiovascular outcome consisting of acute coronary syndrome, peripheral arterial disease, arterial revascularization (coronary, cerebral, or peripheral), cerebrovascular disease, or cardiovascular or cerebrovascular death.
Time frame: 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.
Proportion of participants who die from any cause
Proportion of participants who die from any cause during the study follow-up period.
Time frame: From randomization until death or the end of study follow-up, assessed up to 5 years.
Plan to share: No
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Acquired Immunodeficiency Syndrome →
Fundacion SEIMC-GESIDA