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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital del Mar, Barcelona
RECRUITING
Barcelona
Contact Information
Primary
Robert Güerri-Fernánderz, M.D. Ph.D.
rguerri@hmar.org
+34932483251
Backup
Juan Jose Chillaron, M.D. Ph.D.
jchillaron@psmar.cat
+34 932483251
Time Frame
Start Date: 2024-12-31
Estimated Completion Date: 2026-07
Participants
Target number of participants: 64
Treatments
No_intervention: Standard of Care
Standard of care arm will be the management as currently is provided. It provides participants with general dietary advice through informational leaflets. No personalized counseling or follow-up sessions are included. Participants continue their usual diet, receiving only baseline and routine assessments without additional support to modify their dietary habits or improve adherence to healthier eating patterns.
Experimental: Intervention
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.
Related Therapeutic Areas
Sponsors
Leads: Parc de Salut Mar

This content was sourced from clinicaltrials.gov