Impact of Mediterranean Diet in Cardiovascular Risk Among People With HIV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorParc de Salut Mar
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Mediterranean Diet
BehavioralIntervention 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
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Standard of CareNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in LDL profile between groups
Difference in the mean change (mg/dL) in LDL cholesterol between the intervention group and the standard of care (SoC) group at week 24, relative to baseline values.
Time frame
24 weeks2
Changes in HDL cholesterol
Difference in the mean change (mg/dL) in HDL cholesterol between the intervention group and the standard of care (SoC) group at week 24, relative to baseline values.
Time frame
week 24 respec to baseline3
Changes in body mass index
Difference in the mean change in body Mass Index between the intervention group and the standard of care (SoC) group at week 24, relative to baseline values.
Time frame
24 weeks4
Changes in very low density lipoprotein by spectral MRI
Difference in the mean change in very low lipoprotein between the intervention group and the standard of care (SoC) group at week 24, relative to baseline values measured by spectral MRI
Time frame
24 weeksSecondary outcomes
1
Changes in CD38+CD4+T-cell
Difference in the mean percentage change in CD38+CD4+ T-cell levels between the intervention group and the standard of care (SoC) group at week 24, relative to baseline values, as measured by flow cytometry.
Time frame
24 weeks2
Changes in CD38+CD8+T-cell
Difference in the mean percentage change in CD38+CD8+T-cell levels between the intervention group and the standard of care (SoC) group at week 24, relative to baseline values, as measured by flow cytometry.
Time frame
24 weeks3
change in Exhaustion CD4 T-cells
Difference in the mean percentage change in PD1+CD4+T-cells levels between the intervention group and the standard of care (SoC) group at week 24, relative to baseline values, as measured by flow cytometry.
Time frame
24 weeks4
Changes in PD1+CD8+T-cells
Difference in the mean percentage change in PD1+CD8+T-cells levels between the intervention group and the standard of care (SoC) group at week 24, relative to baseline values, as measured by flow cytometry.
Time frame
week 24Sponsors and contacts
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Source ClinicalTrials.gov