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

Changes in Bacterial Translocation and Immune Activation in Patients Infected With HIV After Change to a Supplemented Mediterranean Diet: Two Arms Randomized Prospective Trial.

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.

Study Overview

• Status: Unknown
• Conditions: Hiv
• Intervention / Treatment: Dietary supplement: mediterranean diet

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.

• Study Type: Interventional
• Enrollment (Anticipated): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Felipen Garcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mediterranean diet; Patients do Mediterranean diet supplemented with 50 g / day of olive oil and 15g / day of nuts for three months	Dietary supplement: mediterranean diet; a Mediterranean diet supplemented with 50 g / day of olive oil and 15g / day of nuts for three months
No Intervention: Usual diet; Patients do usual diet for three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in levels of sCD14 at baseline and month 3 between groups	parameters of bacterial translocation	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in EndocAB and LBP levels at baseline and month 3 between groups.	other parameters of bacterial translocation.	2 year
Changes in microbiota (fecal 16s rRNA) at baseline and month 3 between groups	Microbioma	2 years
Changes in ultrasensitive PCR, TNF-alpha, IL-6 and Dimer-D at baseline and month 3 between groups	inflammatory markers	2 years
Changes in lipids at baseline and month 3 between groups	Lipids	2 years
Changes in expression of CD38, HLA DR in CD4 and CD8 T cells at baseline and month 3 between groups	immune-activation markers	2 years
Changes in total and integrated DNA	Marker of HIV reservoir	2 years

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Principal Investigator: Felipe García, MD, PhD, Institut d'Investigacions Biomèdiques August Pi i Sunyer

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: June 14, 2017
• First Submitted That Met QC Criteria: February 15, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Mediterranean Diet; Microbiota.; Bacterial Traslocation
• Other Study ID Numbers: Clinic Hospital of Barcelona

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No