Exploring the Mediterranean diet's effects on cardiovascular risk in people with HIV
Randomized Study to Evaluate the Impact of Dietary Optimization on Metabolic Profile, Immunoactivation and Cardiovascular Risk in HIV Population on ART
NA · Parc de Salut Mar · NCT06757309
This study is testing if following a Mediterranean diet can help improve heart health for people living with HIV who are on treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Parc de Salut Mar (other) |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06757309 on ClinicalTrials.gov |
What this trial studies
The VIHMET study investigates how adopting a Mediterranean diet can improve health outcomes for people living with HIV who are on antiretroviral therapy. This randomized clinical trial will involve 64 participants from the HIV outpatient clinic at Hospital del Mar in Barcelona, who will be divided into intervention and control groups. The intervention group will receive personalized nutritional counseling to enhance adherence to the Mediterranean diet, while the control group will follow standard dietary recommendations. Health indicators such as lipid profiles and immune activation markers will be assessed at baseline, week 24, and week 48 to evaluate the impact of dietary changes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed HIV diagnosis, stable on antiretroviral therapy, and low adherence to the Mediterranean diet.
Not a fit: Patients using lipid-lowering medications or with chronic inflammatory conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular health and overall quality of life for people living with HIV.
How similar studies have performed: While dietary interventions in HIV populations are being explored, this specific approach focusing on the Mediterranean diet is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Barcelona
- Hospital del Mar, Barcelona — Barcelona, Spain (RECRUITING)
Study contacts
- Study coordinator: Robert Güerri-Fernánderz, M.D. Ph.D.
- Email: rguerri@hmar.org
- Phone: +34932483251
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HIV Infection, Inflammation, Cardiovascular Risk, Mediterranean Diet, HIV, Coronary Artery