Clinical Trial

Impact of Mediterranean Diet in Cardiovascular Risk Among People With HIV

Study acronym: VIHMED
Unknown
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Record status
This record was last updated January 3, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Unknown 2026-08-09
Trial Details
NCT Number NCT06757309
Lead Sponsor Parc de Salut Mar
Conditions HIV Infection, Inflammation, Cardiovascular Risk, Mediterranean Diet
Enrollment 64 participants
Start Date 2024-12-31
Primary Completion 2025-12 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2025-01-03