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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
a Mediterranean diet supplemented with 50 g / day of olive oil and 15g / day of nuts for three months
Felipen Garcia
Barcelona, Spain
Differences in levels of sCD14 at baseline and month 3 between groups
parameters of bacterial translocation
Time frame: 2 year
Changes in EndocAB and LBP levels at baseline and month 3 between groups.
other parameters of bacterial translocation.
Time frame: 2 year
Changes in microbiota (fecal 16s rRNA) at baseline and month 3 between groups
Microbioma
Time frame: 2 years
Changes in ultrasensitive PCR, TNF-alpha, IL-6 and Dimer-D at baseline and month 3 between groups
inflammatory markers
Time frame: 2 years
Changes in lipids at baseline and month 3 between groups
Lipids
Time frame: 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
Time frame: 2 years
Changes in total and integrated DNA
Marker of HIV reservoir
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.