Olive oil as a shield? trial tests whether a daily spoonful cuts heart risks in HIV
NCT ID NCT07761819
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
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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
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About 1,324 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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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
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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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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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Universitario Costa del Sol
Marbella, Málaga, 29603, Spain
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