Actively Recruiting
Impact of Mediterranean Diet in Cardiovascular Risk Among People With HIV
Led by Parc de Salut Mar · Updated on 2025-01-03
64
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Impact of Mediterranean Diet in Cardiovascular Risk Among People With HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Able to swallow tablets
- Willing and able to provide informed consent
You will not qualify if you...
- Use of lipid-lowering medications
- Chronic use of anti-inflammatory drugs
- Active hepatitis B or hepatitis C infection
- Other chronic inflammatory conditions such as autoimmune diseases
- Familial hypercholesterolemia
- Uncontrolled metabolic conditions like hypothyroidism or diabetes mellitus
- Pregnancy or breastfeeding
- Cognitive or psychological conditions impairing compliance with study protocol
- Inability to provide informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital del Mar, Barcelona
Barcelona, Spain, 08034
Actively Recruiting
Research Team
R
Robert Güerri-Fernánderz, M.D. Ph.D.
CONTACT
J
Juan Jose Chillaron, M.D. Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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