Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT03846206
Status:
UNKNOWN
Last Update Posted:
2019-08-21
First Post:
2017-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mediterranean Diet and Bacterial Translocation and Immune-activation in Patients With HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D038441', 'term': 'Diet, Mediterranean'}], 'ancestors': [{'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '. 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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-07-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-20', 'studyFirstSubmitDate': '2017-06-14', 'studyFirstSubmitQcDate': '2019-02-15', 'lastUpdatePostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in levels of sCD14 at baseline and month 3 between groups', 'timeFrame': '2 year', 'description': 'parameters of bacterial translocation'}], 'secondaryOutcomes': [{'measure': 'Changes in EndocAB and LBP levels at baseline and month 3 between groups.', 'timeFrame': '2 year', 'description': 'other parameters of bacterial translocation.'}, {'measure': 'Changes in microbiota (fecal 16s rRNA) at baseline and month 3 between groups', 'timeFrame': '2 years', 'description': 'Microbioma'}, {'measure': 'Changes in ultrasensitive PCR, TNF-alpha, IL-6 and Dimer-D at baseline and month 3 between groups', 'timeFrame': '2 years', 'description': 'inflammatory markers'}, {'measure': 'Changes in lipids at baseline and month 3 between groups', 'timeFrame': '2 years', 'description': 'Lipids'}, {'measure': 'Changes in expression of CD38, HLA DR in CD4 and CD8 T cells at baseline and month 3 between groups', 'timeFrame': '2 years', 'description': 'immune-activation markers'}, {'measure': 'Changes in total and integrated DNA', 'timeFrame': '2 years', 'description': 'Marker of HIV reservoir'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microbiota.', 'Mediterranean Diet', 'Bacterial Traslocation'], 'conditions': ['Hiv']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient ≥ 18 years of age;\n* To sign voluntary informed consent;\n* Male or female patients with a negative pregnancy test before inclusion in the study;\n* Proven HIV infection (with HIV-1 positive antibodies);\n* Patient should be on stable treatment with cART for at least 1 year\n* The mean of all CD4 measurements during the year prior to the initiation of cART should be equal to greater than 350 cells / mm3\n* The number of CD4 + at the time of recruitment must be equal to or greater than 500 cells / mm3;\n* 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).\n\nExclusion Criteria:\n\n* Acquired Immunodeficiency Syndrome.\n* Active opportunistic diseases.\n* Patients coinfected with HCV or HBV\n* Coagulopathy\n* Renal insufficiency (creatinine\\> 1.5 mg / dL)\n* Pregnancy or breastfeeding\n* Inability to sign informed consent\n* Active opportunistic infections, or any active infection or cancer within 30 days prior to the screening visit;\n* Therapy with immunomodulatory agents, including cytokines (eg IL-2) and gammaglobulins or chemotherapy within 90 days prior to the screening visit;\n* Use of anticoagulant medication;\n* Use of any type of experimental medication during the 90 days prior to study entry;\n* Uncontrolled psychiatric disorder;\n* Patients with uncontrolled active autoimmune diseases;\n* Usual use of antibiotics'}, 'identificationModule': {'nctId': 'NCT03846206', 'briefTitle': 'Mediterranean Diet and Bacterial Translocation and Immune-activation in Patients With HIV', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Changes in Bacterial Translocation and Immune Activation in Patients Infected With HIV After Change to a Supplemented Mediterranean Diet: Two Arms Randomized Prospective Trial.', 'orgStudyIdInfo': {'id': 'Clinic Hospital of Barcelona'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mediterranean diet', 'description': 'Patients do Mediterranean diet supplemented with 50 g / day of olive oil and 15g / day of nuts for three months', 'interventionNames': ['Dietary Supplement: mediterranean diet']}, {'type': 'NO_INTERVENTION', 'label': 'Usual diet', 'description': 'Patients do usual diet for three months'}], 'interventions': [{'name': 'mediterranean diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'a Mediterranean diet supplemented with 50 g / day of olive oil and 15g / day of nuts for three months', 'armGroupLabels': ['mediterranean diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Felipen Garcia', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Felipe García, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut d'Investigacions Biomèdiques August Pi i Sunyer"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DOCTOR', 'investigatorFullName': 'Felipe Garcia', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}