Mediterranean Diet and Bacterial Translocation and Immune-activation in Patients With HIV

NCT ID: NCT03846206

Last Updated: 2019-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-01
• Study Completion Date: 2019-12-01

Brief Summary

Evaluate if a change to a Mediterranean diet supplemented with nuts and olive oil decreases bacterial translocation and immune activation by a change in the microbiome in successfully treated HIV-1 infected patients with CD4> 500cells/ml.

Detailed Description

Mediterranean diet supplemented by nuts and extra virgin olive oil has shown to reduce mortality, cardiovascular diseases, and breast cancer in HIV uninfected individuals. It is likely that changes in the microbiome could play a role in this effect. The goal of the study is to evaluate if a change to a Mediterranean diet supplemented with nuts and olive oil decreases bacterial translocation and immune activation by a change in the microbiome in successfully treated HIV-1 infected patients with CD4> 500cells/ml. One hundred and two patients who will be randomized to continues usual diet or to a Mediterranean diet supplemented with 50 g / day of olive oil and 15g / day of nuts for three months. Throughout the study a specialized dietician will monitor the patients. Blood samples will be collected to assess parameters of bacterial translocation, inflammation and immune activation. To assess compliances with diet, urine samples will be collected too, and stool samples to study changes in gut microbiota. All the samples will be collected at the beginning and 90 days after the inclusion in the study.

Conditions

Hiv

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mediterranean diet

Patients do Mediterranean diet supplemented with 50 g / day of olive oil and 15g / day of nuts for three months

Group Type: EXPERIMENTAL

mediterranean diet

Intervention Type: DIETARY_SUPPLEMENT

a Mediterranean diet supplemented with 50 g / day of olive oil and 15g / day of nuts for three months

Usual diet

Patients do usual diet for three months

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

mediterranean diet

a Mediterranean diet supplemented with 50 g / day of olive oil and 15g / day of nuts for three months

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Patient ≥ 18 years of age;
• To sign voluntary informed consent;
• Male or female patients with a negative pregnancy test before inclusion in the study;
• Proven HIV infection (with HIV-1 positive antibodies);
• Patient should be on stable treatment with cART for at least 1 year
• The mean of all CD4 measurements during the year prior to the initiation of cART should be equal to greater than 350 cells / mm3
• The number of CD4 + at the time of recruitment must be equal to or greater than 500 cells / mm3;
• HIV viral load should be undetectable at least 6 months prior to study inclusion, and less determinations (occasional blips above the undetectable level are allowed).

Exclusion Criteria

• Acquired Immunodeficiency Syndrome.
• Active opportunistic diseases.
• Patients coinfected with HCV or HBV
• Coagulopathy
• Renal insufficiency (creatinine> 1.5 mg / dL)
• Pregnancy or breastfeeding
• Inability to sign informed consent
• Active opportunistic infections, or any active infection or cancer within 30 days prior to the screening visit;
• Therapy with immunomodulatory agents, including cytokines (eg IL-2) and gammaglobulins or chemotherapy within 90 days prior to the screening visit;
• Use of anticoagulant medication;
• Use of any type of experimental medication during the 90 days prior to study entry;
• Uncontrolled psychiatric disorder;
• Patients with uncontrolled active autoimmune diseases;
• Usual use of antibiotics

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Felipe Garcia

DOCTOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Felipe García, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Locations

Felipen Garcia

Barcelona, , Spain

Countries

Spain

Other Identifiers

Clinic Hospital of Barcelona

Identifier Type: -

Identifier Source: org_study_id