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Olive oil as a shield? trial tests whether a daily spoonful cuts heart risks in HIV

NCT ID NCT07761819

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial asks whether taking 50 mL of extra virgin olive oil every day can reduce the chance of heart attacks, strokes, and related deaths in people living with HIV. About 1,300 adults aged 50–75 with well-controlled HIV and at least one heart risk factor will be randomly assigned to add olive oil to their diet or to continue their usual eating habits. Over five years, researchers will compare how many in each group experience a major cardiovascular event, and also track changes in weight, blood pressure, and other health markers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Extra virgin olive oil (EVOO) taken daily as a dietary supplement
What this could lead to
If it works, daily olive oil could become a simple, low-cost way to lower heart and stroke risk in people living with HIV.
What could go wrong
This is an open-label trial, so results may be influenced by expectations. The effect may be modest, and daily intake of 50 mL adds calories, which could affect weight.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,324 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * 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: * 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 * 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)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Hospital Universitario Costa del Sol

    Marbella, Málaga, 29603, Spain

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