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

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.

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)