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

NCT03846206 | Unknown

• 1 other identifier: Clinic Hospital of Barcelona
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Hiv

Keywords

Microbiota.; Mediterranean Diet; Bacterial Traslocation

Outcome Measures

Primary Outcomes (1)

• Differences in levels of sCD14 at baseline and month 3 between groups

  parameters of bacterial translocation

  2 year

Secondary Outcomes (6)

• Changes in EndocAB and LBP levels at baseline and month 3 between groups.

  2 year

• Changes in microbiota (fecal 16s rRNA) at baseline and month 3 between groups

  2 years

• Changes in ultrasensitive PCR, TNF-alpha, IL-6 and Dimer-D at baseline and month 3 between groups

  2 years

• Changes in lipids at baseline and month 3 between groups

  2 years

• Changes in expression of CD38, HLA DR in CD4 and CD8 T cells at baseline and month 3 between groups

  2 years

Study Arms (2)

mediterranean diet

EXPERIMENTAL

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

Dietary Supplement: mediterranean diet

Usual diet

NO INTERVENTION

Patients do usual diet for three months

Interventions

mediterranean diet DIETARY_SUPPLEMENT

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

mediterranean diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥ 18 years of age;
• To sign voluntary informed consent;
• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Felipen Garcia

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Felipe García, MD, PhD

  Institut d'Investigacions Biomèdiques August Pi i Sunyer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DOCTOR

Model Details: . 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 Record Dates

• First Submitted: June 14, 2017
• First Posted: February 19, 2019
• Study Start: July 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 21, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)