Actively Recruiting
Randomized Study to Evaluate the Impact of Dietary Optimization on Metabolic Profile, Immunoactivation and Cardiovascular Risk in HIV Population on ART
Led by Parc de Salut Mar · Updated on 2025-01-03
64
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how adopting a Mediterranean diet may improve health outcomes in adults living with HIV who are on antiretroviral therapy (ART). People living with HIV often face chronic inflammation, metabolic issues, and higher cardiovascular risks partly due to the virus, immune activation, and ART side effects. This randomized clinical trial aims to evaluate whether dietary changes can reduce these risks and improve quality of life. The study will enroll 64 participants who will be randomly assigned to either a control group receiving standard dietary advice or an intervention group receiving personalized nutritional counseling to enhance adherence to the Mediterranean diet. The intervention includes tailored meal plans, education on food choices emphasizing fruits, vegetables, whole grains, healthy fats, and fish, and virtual follow-ups at weeks 4 and 12. The study duration is 48 weeks, with assessments at baseline, week 24, and week 48. Participants will undergo various evaluations including lipid profiles, inflammatory and immune activation markers, arterial stiffness measurements, and coronary plaque imaging via non-invasive techniques. They will also complete questionnaires on diet adherence, physical activity, and quality of life, alongside body measurements. The study monitors changes over time to assess the impact of dietary intervention on cardiovascular and metabolic health in people living with HIV.
CONDITIONS
Brief 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 with an undetectable viral load for at least 12 months
- LDL cholesterol levels greater than 140 mg/dL
- Low adherence to the Mediterranean diet, defined by a MEDAS score less than 9
- Ability to swallow tablets
- Willingness and ability 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 the ability to comply with the study protocol
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 weeks
Participants follow their assigned dietary plan. The intervention group receives personalized counseling to adopt the Mediterranean diet with tailored meal plans and educational materials. They have virtual follow-up sessions at weeks 4 and 12 to support adherence and address challenges. The control group receives general dietary advice through informational leaflets without personalized counseling or follow-up.
3 clinical visits at baseline, week 24, and week 48; 2 virtual follow-up sessions at weeks 4 and 12 for the intervention group
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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