NCT06757309 Impact of Mediterranean Diet in Cardiovascular Risk Among People With HIV
| NCT ID | NCT06757309 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Parc de Salut Mar |
| Condition | HIV Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2024-12-31 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 64 participants in total. It began in 2024-12-31 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study (VIHMET) aims to explore how dietary changes, specifically the adoption of a Mediterranean diet, can improve health outcomes in people living with HIV (PLWH) who are on antiretroviral therapy (ART). PLWH often experience chronic inflammation, metabolic disturbances, and elevated cardiovascular risk due to the virus, immune activation, and ART-related side effects. By examining dietary interventions, this study seeks strategies to reduce these risks and enhance quality of life. The VIHMET study is a randomized clinical trial involving 64 participants at Hospital del Mar, Barcelona, randomized into control and intervention groups (1:2 ratio). The intervention group will receive personalized nutritional counseling to improve adherence to the Mediterranean diet, focusing on food selection and meal preparation. The control group will follow standard dietary recommendations. Assessments will occur at baseline, week 24, and week 48. Key health indicators include lipid profiles, markers of inflammation, immune activation, and cardiovascular health, assessed through non-invasive techniques like arterial stiffness and subclinical atherosclerosis measurements. Participants will complete questionnaires on diet adherence, physical activity, and quality of life, alongside anthropometric evaluations. Eligible participants are adults with HIV, undetectable viral loads for 12+ months, and elevated LDL cholesterol with low Mediterranean diet adherence. Exclusion criteria include lipid-lowering drugs, chronic anti-inflammatory therapy, or other active inflammatory/metabolic conditions. This study aims to improve lipid levels, reduce inflammation, decrease arterial stiffness, and assess diet adherence's impact on quality of life and subclinical atherosclerosis. Results may inform dietary recommendations to reduce cardiovascular risks and enhance holistic care for PLWH.
Eligibility Criteria
Inclusion Criteria: * Adults aged 18 years or older. * Confirmed diagnosis of HIV infection. * On stable antiretroviral therapy (ART) with an undetectable viral load for at least 12 months. * LDL cholesterol levels \>140 mg/dL. * Low adherence to the Mediterranean diet, defined by a MEDAS score \<9. * Must be able to swallow tablets * Willingness and ability to provide informed consent. Exclusion Criteria: * Use of lipid-lowering medications. * Chronic use of anti-inflammatory drugs. * Active hepatitis B or hepatitis C infection. * Other chronic inflammatory conditions (e.g., autoimmune diseases). * Familial hypercholesterolemia. * Uncontrolled metabolic conditions, such as hypothyroidism or diabetes mellitus. * Pregnancy or breastfeeding. * Cognitive or psychological conditions impairing the ability to comply with the study protocol. * Inability to provide informed consent.
Contact & Investigator
Robert Güerri-Fernández, M.D. Ph.D.
STUDY CHAIR
Hospital del Mar
Frequently Asked Questions
Who can join the NCT06757309 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06757309 currently recruiting?
Yes, NCT06757309 is actively recruiting participants. Contact the research team at rguerri@hmar.org for enrollment information.
Where is the NCT06757309 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT06757309 clinical trial?
NCT06757309 is sponsored by Parc de Salut Mar. The principal investigator is Robert Güerri-Fernández, M.D. Ph.D. at Hospital del Mar. The trial plans to enroll 64 participants.
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