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Not yet recruitingNCT07761819OLEUM VIHTAEUpdated Aug 12, 2026

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

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.

Primary conditionAcquired Immunodeficiency Syndrome(the registry's first term)UnverifiedIs this wrong?The registry often attaches Acquired Immunodeficiency Syndrome to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Fundacion SEIMC-GESIDA · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
1,324
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

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.

Read the detailed description

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.

02

Conditions studied

  • HIV - Human Immunodeficiency Virus

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Keywords

  • cardiovascular
  • extra virgin olive oil
  • HIV
  • elderly population
  • Gut microbiota
  • Epigenetic age
  • Hydroxytyrosol
  • Inflamm-aging
  • Inflammatory biomarkers
03

In context

Acquired Immunodeficiency Syndrome Unverified

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 →

Lead sponsor

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 →

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • -1 infection with at least one year since diagnosis
  • Ability to sign the 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

Exclusion Criteria:

  • Presence of ischemic heart disease, cerebrovascular disease, or peripheral arterial disease in any form.
  • Cardiovascular risk calculated by ASCVD VR10 less than 5%.
  • of less than one year in the investigator's opinion.
  • Inability to complete the study in the investigator's opinion.
  • Presence of Child stage C cirrhosis, end-stage renal failure ( by CKD-EPI \<10 mL/min or dialysis in any form), dementia.
  • Diagnosis prior to inclusion in the study of diseases requiring chemotherapy, radiotherapy, or major surgery
  • Completion of chemotherapy or radiotherapy within three months prior to inclusion in the study
  • Major surgery in the three months prior to inclusion in the study (any procedure performed in an operating room that involves incision, excision, manipulation, or suturing of tissue; generally requires regional or general anesthesia or deep sedation for pain control).
  • Current diagnosis of wasting syndrome or >40
  • Inability to follow a Mediterranean diet
  • Institutionalized or dependent patients
  • Patients with chronic inflammatory conditions other than (e.g., inflammatory bowel disease, lupus, rheumatoid arthritis, etc., except for skin diseases treated exclusively with topical therapy). In cases where there is doubt about the inclusion of a particular condition, the investigator should consult with the study monitor beforehand.
  • Presence of diseases or conditions that, in the investigator's opinion, may hinder absorption.
  • Active neoplasia at the time of inclusion or in the previous six months, except for non-melanoma skin cancer or anal carcinoma in situ.
  • Reported intake of at least 30 mL of EVOO per day (equivalent to two tablespoons of oil)
Terms in these criteria, in plain language(5)

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.

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.

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.

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,324 participants (estimated)

Study arms

  • Experimental
    Extra Virgin Olive Oil Arm

    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
    No Extra Virgin Olive Oil Arm

    No Intervention

Interventions

  • Dietary supplementThe 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

06

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07761819
Lead sponsor
Fundacion SEIMC-GESIDA
Responsible party
Sponsor
First posted
Aug 12, 2026
Start date
Oct 31, 2026 (estimated)
Primary completion
Jun 15, 2031 (estimated)
Completion
Dec 15, 2031 (estimated)
Last update
Aug 12, 2026

Study contacts

Julián Olalla
Contact
julio.olalla@gmail.com
034951293854 ext. 973854

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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