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

Inclusion Criteria7

  • 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 Criteria9

  • 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.

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06757309


Related Trials