Impact of Mediterranean Diet in Cardiovascular Risk Among People With HIV

NCT06757309 | Recruiting

• 1 other identifier: 2022/10496/I
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIV; Inflammation; Coronary Artery

Outcome Measures

Primary Outcomes (4)

• 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.

  24 weeks

• 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.

  week 24 respec to baseline

• 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.

  24 weeks

• 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

  24 weeks

Secondary Outcomes (14)

• Changes in CD38+CD4+T-cell

  24 weeks

• Changes in CD38+CD8+T-cell

  24 weeks

• change in Exhaustion CD4 T-cells

  24 weeks

• Changes in PD1+CD8+T-cells

  week 24

• Change in Pulse wave velocity

  week 24

Study Arms (2)

Standard of Care

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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.

Behavioral: Mediterranean Diet

Interventions

Mediterranean Diet BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar, Barcelona

Barcelona, 08034, Spain

RECRUITING

MeSH Terms

Conditions

HIV Infections; Inflammation

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Robert Güerri-Fernández, M.D. Ph.D.

  Hospital del Mar

  STUDY CHAIR

• Juan Jose Chillarón-Jordan, M.D. Ph.D.

  Hospital del Mar

  STUDY CHAIR

Central Study Contacts

Robert Güerri-Fernánderz, M.D. Ph.D.

CONTACT

+34932483251; rguerri@hmar.org

Juan Jose Chillaron, M.D. Ph.D.

CONTACT

+34 932483251; jchillaron@psmar.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: January 3, 2025
• Study Start: December 31, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 3, 2025

Record last verified: 2024-07

Locations

ES (1)