HIV - Human Immunodeficiency VirusOLEUM VIHTAENCT07761819
Effect of Extra Virgin Olive Oil Consumption on the Occurrence of Cardiovascular Events in Population Living With HIV
A study testing The patients must ingest 50 mL of extra virgin olive oil daily in people with HIV - Human Immunodeficiency Virus, run by Fundacion SEIMC-GESIDA at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV - Human Immunodeficiency Virus
- What is being tested?
- The patients must ingest 50 mL of extra virgin olive oil daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,324 participants
- Where
- 1 siteSpain
- Study dates
- 31 Oct 2026to 15 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- 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.
Show all 9Show fewer
- 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)
Who cannot join
- 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.
- Presence of Child stage C cirrhosis, end-stage renal failure (eGFR 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
Show all 15Show fewer
- 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 BMI>40
- Inability to follow a Mediterranean diet
- Institutionalized or dependent patients
- Patients with chronic inflammatory conditions other than HIV (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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Universitario Costa del Sol
Marbella, Málaga, 29603
Julián Olalla, 034951293854 ext. 973854, julio.olalla@gmail.com
About this study
Official title: 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
Read more
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.
- Conditions
- HIV - Human Immunodeficiency Virus
- Being tested
- The patients must ingest 50 mL of extra virgin olive oil daily
- Keywords
- cardiovascular, extra virgin olive oil, HIV, elderly population, Gut microbiota, Epigenetic age, Hydroxytyrosol, Inflamm-aging, Inflammatory biomarkers
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The patients must ingest 50 mL of extra virgin olive oil dailyDietary supplement
Cardiovascular risk analysis in HIV elder patients ingesting 50 mL of extra virgin olive oil daily
| Study group | Role | What they receive |
|---|---|---|
| Extra Virgin Olive Oil Arm | Experimental | The patients enrolled in this arm must ingest 50 mL of extra virgin olive oil daily Receives: Dietary Supplement: The patients must ingest 50 mL of extra virgin olive oil daily |
| No Extra Virgin Olive Oil Arm | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From randomization until death or the end of study follow-up, assessed up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start31 Oct 2026 (estimated)
- Primary completion15 Jun 2031 (estimated)
- Study completion15 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV - Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion SEIMC-GESIDA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761819
- Sponsor's protocol ID
- GESIDA 12725
- Acronym
- OLEUM VIHTAE
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF EXTRA VIRGIN OLIVE OIL CONSUMPTION ON THE OCCURRENCE OF CARDIOVASCULAR EVENTS IN POPULATION LIVING WITH HIV
- ClinicalTrials.gov ID
- NCT07761819
- Acronym / sponsor ID
- OLEUM VIHTAE / GESIDA 12725
- Conditions
- HIV - Human Immunodeficiency Virus
- Keywords
- cardiovascular, extra virgin olive oil, HIV, elderly population, Gut microbiota, Epigenetic age, Hydroxytyrosol, Inflamm-aging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,324 participants (estimated)
- Lead sponsor
- Fundacion SEIMC-GESIDAUniversity, hospital or other
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 15 Jun 2031 (estimated)
- Study completion
- 15 Dec 2031 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extra Virgin Olive Oil Arm | Experimental | Dietary Supplement: The patients must ingest 50 mL of extra virgin olive oil dailyThe patients enrolled in this arm must ingest 50 mL of extra virgin olive oil daily |
| No Extra Virgin Olive Oil Arm | No intervention | –No Intervention |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
- 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.
Key exclusion criteria (15 listed)
- 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.
- Presence of Child stage C cirrhosis, end-stage renal failure (eGFR by CKD-EPI <10 mL/min or dialysis in any form), dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The patients must ingest 50 mL of extra virgin olive oil dailyCardiovascular risk analysis in HIV elder patients ingesting 50 mL of extra virgin olive oil daily | Dietary supplement | Extra Virgin Olive Oil Arm |
Primary outcome
Proportion of participants with a major cardiovascular event or cardiovascular/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 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.
1 secondary outcome
Proportion of participants who die from any cause
Time frame: From randomization until death or the end of study follow-up, assessed up to 5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for HIV - Human Immunodeficiency Virus
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The patients must ingest 50 mL of extra virgin olive oil daily in people with HIV - Human Immunodeficiency Virus, run by Fundacion SEIMC-GESIDA at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julián Olalla (034951293854 ext. 973854, julio.olalla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with a major cardiovascular event or cardiovascular/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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.