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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mediterranean diet | Experimental | Patients do Mediterranean diet supplemented with 50 g / day of olive oil and 15g / day of nuts for three months |
|
| Usual diet | No Intervention | Patients do usual diet for three months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mediterranean diet | Dietary Supplement | a Mediterranean diet supplemented with 50 g / day of olive oil and 15g / day of nuts for three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differences in levels of sCD14 at baseline and month 3 between groups | parameters of bacterial translocation | 2 year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felipe GarcÃa, MD, PhD | Institut d'Investigacions Biomèdiques August Pi i Sunyer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Felipen Garcia | Barcelona | 08036 | Spain |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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. 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.
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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 |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |