Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06757309

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Hospital del Mar, Barcelona

Barcelona, Spain, 08034

Actively Recruiting

Loading map...

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

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here