Actively Recruiting
Randomized Study on Mediterranean Diet Effects for Cardiovascular and Metabolic Health in People With HIV on Antiretroviral Therapy
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 research aims to explore how adopting a Mediterranean diet can improve health outcomes for adults living with HIV who are on antiretroviral therapy (ART). People living with HIV often face chronic inflammation, immune activation, and increased cardiovascular risk due to the virus and ART side effects. This study seeks to find dietary strategies to reduce these risks and enhance quality of life by improving metabolic health and reducing immune activation. The study is a randomized clinical trial involving 64 participants with HIV at Hospital del Mar in Barcelona, divided into a control group and an intervention group in a 1:2 ratio. The intervention group receives personalized counseling to follow the Mediterranean diet, including tailored meal plans, education on food choices, and virtual follow-ups at weeks 4 and 12 to support adherence. The control group receives general dietary advice through informational leaflets without individualized counseling. Participants will be followed for 48 weeks with evaluations at baseline, week 24, and week 48. Participants will attend clinical visits where researchers will collect medical history, measure body mass index, waist circumference, weight, and assess diet adherence through questionnaires. Laboratory tests will track lipid profiles, inflammatory and immune markers, and other biomarkers, while imaging tests will evaluate arterial stiffness and coronary plaque burden. The study will measure changes in cholesterol levels, inflammation, arterial stiffness, diet adherence, quality of life, and cardiovascular risk indicators over 24 and 48 weeks to assess the impact of dietary changes.
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.
J
Juan Jose Chillaron, M.D. Ph.D.
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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