EFFECT OF EXTRA VIRGIN OLIVE OIL CONSUMPTION ON THE OCCURRENCE OF CARDIOVASCULAR EVENTS IN POPULATION LIVING WITH HIV
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,324
- 试验地点
- 1
- 主要终点
- Proportion of participants with a major cardiovascular event or cardiovascular/cerebrovascular death
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
Extra Virgin Olive Oil Arm
The patients enrolled in this arm must ingest 50 mL of extra virgin olive oil daily
干预措施: The patients must ingest 50 mL of extra virgin olive oil daily (Dietary Supplement)
No Extra Virgin Olive Oil Arm
No Intervention
结局指标
主要结局
Proportion of participants with a major cardiovascular event or cardiovascular/cerebrovascular death
时间窗: 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.
次要结局
- Proportion of participants who die from any cause(From randomization until death or the end of study follow-up, assessed up to 5 years.)