Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06757309

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

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 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
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 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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

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

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

Similar Trials

#AWARE.HIV Europe: Supporting Healthcare Professionals to Fi...

HIV Infection

Actively Recruiting

28 locations

Anakinra Pilot 2 - Optimising Dose and Administration Route ...

Premature Infants

Actively Recruiting

2 locations

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