RecruitingNot ApplicableNCT06757309

Impact of Mediterranean Diet in Cardiovascular Risk Among People With HIV

Randomized Study to Evaluate the Impact of Dietary Optimization on Metabolic Profile, Immunoactivation and Cardiovascular Risk in HIV Population on ART


Sponsor

Parc de Salut Mar

Enrollment

64 participants

Start Date

Dec 31, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether following a Mediterranean diet — rich in vegetables, fruits, whole grains, and healthy fats — can help lower cholesterol and reduce heart disease risk in people living with HIV who are on stable treatment. **You may be eligible if...** - You are 18 or older - You have a confirmed HIV diagnosis - You have been on stable HIV medication with an undetectable viral load for at least 12 months - Your LDL ("bad") cholesterol is above 140 mg/dL - You are not currently following a Mediterranean diet closely **You may NOT be eligible if...** - You are already taking cholesterol-lowering medications (statins, etc.) - You have active hepatitis B or C - You have autoimmune disease or other chronic inflammatory conditions - You are pregnant or breastfeeding - You have uncontrolled thyroid problems or diabetes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMediterranean Diet

Intervention consists in personalized counseling to adopt the Mediterranean diet, focusing on whole foods, healthy fats, and lean proteins. Participants receive tailored meal plans, educational materials, and practical tips. Follow-up sessions at weeks 4 and 12 offer support, progress reviews, and goal-setting to ensure adherence and improved health outcomes


Locations(1)

Hospital del Mar, Barcelona

Barcelona, Spain

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NCT06757309


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