Impact of Mediterranean Diet in Cardiovascular Risk Among People With HIV

NCT06757309 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-01-03

No results posted yet for this study

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.

Conditions

  • HIV Infection
  • Inflammation
  • Cardiovascular Risk
  • Mediterranean Diet

Interventions

BEHAVIORAL

Mediterranean 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

Sponsors & Collaborators

  • Parc de Salut Mar

    lead OTHER

Principal Investigators

  • Robert Güerri-Fernández, M.D. Ph.D. · Hospital del Mar

  • Juan Jose Chillarón-Jordan, M.D. Ph.D. · Hospital del Mar

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2025-12-31
Completion
2026-07-31

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06757309 on ClinicalTrials.gov