Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2025-12-31 @ 7:22 AM
Study NCT ID:
NCT00925795
Status:
COMPLETED
Last Update Posted:
2010-11-23
First Post:
2009-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Extra Virgin Olive Oil on Atherosclerosis Biomarkers in HIV-infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-08-26', 'releaseDate': '2011-07-28'}], 'estimatedResultsFirstSubmitDate': '2011-07-28'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004467', 'term': 'Economics'}, {'id': 'D000069463', 'term': 'Olive Oil'}], 'ancestors': [{'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-22', 'studyFirstSubmitDate': '2009-06-19', 'studyFirstSubmitQcDate': '2009-06-19', 'lastUpdatePostDateStruct': {'date': '2010-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess whether consumption of extra virgin olive oil (EVOO) leads to improvement of atherosclerosis biomarkers in persons receiving antiretroviral drugs.', 'timeFrame': 'biomarker measurement before and after both intervention periods (20 days each)'}], 'secondaryOutcomes': [{'measure': 'To assess which atherosclerosis biomarkers are the most affected (inflammation, hypercoagulability, dislipidemia, endothelial dysfunction or oxidative stress) by EVOO consumption', 'timeFrame': 'biomarker measurement before and after both intervention periods (20 days each)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'atherosclerosis', 'extra virgin olive oil', 'Alternative therapies', 'Treatment experienced+'], 'conditions': ['HIV', 'Atherosclerosis', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '17321749', 'type': 'BACKGROUND', 'citation': 'Covas MI. Olive oil and the cardiovascular system. Pharmacol Res. 2007 Mar;55(3):175-86. doi: 10.1016/j.phrs.2007.01.010. Epub 2007 Jan 30.'}, {'pmid': '16481154', 'type': 'BACKGROUND', 'citation': 'Perona JS, Cabello-Moruno R, Ruiz-Gutierrez V. The role of virgin olive oil components in the modulation of endothelial function. J Nutr Biochem. 2006 Jul;17(7):429-45. doi: 10.1016/j.jnutbio.2005.11.007. Epub 2005 Dec 12.'}, {'pmid': '16954359', 'type': 'BACKGROUND', 'citation': 'Covas MI, Nyyssonen K, Poulsen HE, Kaikkonen J, Zunft HJ, Kiesewetter H, Gaddi A, de la Torre R, Mursu J, Baumler H, Nascetti S, Salonen JT, Fito M, Virtanen J, Marrugat J; EUROLIVE Study Group. The effect of polyphenols in olive oil on heart disease risk factors: a randomized trial. Ann Intern Med. 2006 Sep 5;145(5):333-41. doi: 10.7326/0003-4819-145-5-200609050-00006.'}, {'pmid': '15765307', 'type': 'BACKGROUND', 'citation': 'Mehta N, Reilly M. Atherosclerotic cardiovascular disease risk in the HAART-treated HIV-1 population. HIV Clin Trials. 2005 Jan-Feb;6(1):5-24. doi: 10.1310/HT0W-NX2N-U2BM-7LUU.'}, {'pmid': '19177019', 'type': 'BACKGROUND', 'citation': 'Francisci D, Giannini S, Baldelli F, Leone M, Belfiori B, Guglielmini G, Malincarne L, Gresele P. HIV type 1 infection, and not short-term HAART, induces endothelial dysfunction. AIDS. 2009 Mar 13;23(5):589-96. doi: 10.1097/QAD.0b013e328325a87c.'}, {'pmid': '26280823', 'type': 'DERIVED', 'citation': 'Kozic Dokmanovic S, Kolovrat K, Laskaj R, Jukic V, Vrkic N, Begovac J. Effect of Extra Virgin Olive Oil on Biomarkers of Inflammation in HIV-Infected Patients: A Randomized, Crossover, Controlled Clinical Trial. Med Sci Monit. 2015 Aug 16;21:2406-13. doi: 10.12659/MSM.893881.'}]}, 'descriptionModule': {'briefSummary': "HIV infection is associated with systemic inflammation that is involved in pathogenesis of atherosclerosis. Treatment of HIV infection may cause lipid profile disturbance and consequently, atherosclerosis progression. In general, extra virgin olive oil (EVOO) has beneficial effect on atherosclerosis markers. Our goals are to examine the effect of EVOO on atherosclerosis markers in HIV-treated patients. A controlled randomized cross-over study will be performed on 40 participants. They will consume EVOO and ROO (refined olive oil) during two 20 days intervention periods, interrupted with 14 days wash-out period. Before the trial and after both intervention periods we will analyze participants' blood for: ESR, white blood cell count, hsCRP, interleukin-6, oxidized LDL, glutathione peroxidase, superoxide dismutase, malondialdehyde, triglycerides, total cholesterol, HDL and LDL cholesterol, fibrinogen, factor VII and von Willebrand factor. We expect an improvement of these parameters after three weeks of EVOO consumption.", 'detailedDescription': 'There are many studies about beneficial effect of extra virgin olive oil on atherosclerosis biomarkers. Our study investigates the same, but in population of HIV-infected patients receiving antiretroviral treatment. The main health benefit of EVOO can be attributed to high content of phenolic compounds, that have a favorable effect on blood pressure, LDL oxidation, platelet aggregation, endothelial function, oxidative stress. We analyzed the total phenolic compounds (PC) in different types of olive oils and decided to use EVOO with four times higher levels of PC than refined olive oil (ROO) which we would use as placebo.\n\nA randomized crossover controlled trial will be performed on 40 participants with signed informed consent. They will be randomly divided in two groups. Each group will consume two types of olive oils (EVOO and ROO) in two intervention periods, but in different order. That means that group "A" will consume EVOO in the first and ROO in the second intervention period. Group "B" has inversed order of olive oil administration. Two intervention periods of 20 days will be interrupted with wash-out period of 14 days. During intervention periods participants will consume daily doses of 50 mL of particular olive oil. During wash-out periods participants should avoid olives and olive oil consumption. Before the first and after each of the two intervention periods, blood will be taken. Some of the tests will be done immediately after blood sample collection (glucose, hsCRP, triglycerides, total cholesterol, HDL and LDL cholesterol, CBC, ESR). For some of the tests (IL-6, von Willebrand factor, factor VII, oxidated LDL, glutathione peroxidase, superoxide dismutase) the specimens will be collected and stored at -80°C until the analysis.\n\nAs many studies showed improvement of these parameters in population affected with atherosclerosis, we could also expect the similar effect in HIV-infected patients who are more likely to develop atherosclerosis, partly because of HIV-infection itself and partly because of side effects of antiretroviral therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-positive patients receiving antiretroviral drugs\n* undetectable HIV viral load in plasma for at least 6 months (by high sensitive Amplicor HIV-1 Monitor, version 1.5)\n* glucose level within reference range\n\nExclusion Criteria:\n\n* pregnant HIV-positive women\n* HIV-patients with underlying acute/chronic diseases (except cardiovascular)'}, 'identificationModule': {'nctId': 'NCT00925795', 'acronym': 'EVOO_HIV', 'briefTitle': 'Effect of Extra Virgin Olive Oil on Atherosclerosis Biomarkers in HIV-infected Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital for Infectious Diseases, Croatia'}, 'officialTitle': 'Effect of Extra Virgin Olive Oil on Atherosclerosis Biomarkers in Patients Treated With Combination Antiretroviral Therapy: a Randomized, Crossover Trial', 'orgStudyIdInfo': {'id': 'UHID-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A (1. EVOO; 2. ROO)', 'interventionNames': ['Other: consumption 1. EVOO; 2. ROO']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (1. ROO; 2. EVOO)', 'interventionNames': ['Other: consumption 1. ROO; 2. EVOO']}], 'interventions': [{'name': 'consumption 1. EVOO; 2. ROO', 'type': 'OTHER', 'otherNames': ['olive oil'], 'description': 'EVOO in doses of 50 mL/daily for 20 days; 14 days of wash-out period without olives and olive oil; followed by ROO in doses of 50 mL/daily for 20 days', 'armGroupLabels': ['Group A (1. EVOO; 2. ROO)']}, {'name': 'consumption 1. ROO; 2. EVOO', 'type': 'OTHER', 'otherNames': ['olive oil'], 'description': 'ROO in doses of 50 mL/daily for 20 days; 14 days of wash-out period without olives and olive oil; followed by EVOO in doses of 50 mL/daily for 20 days', 'armGroupLabels': ['Group B (1. ROO; 2. EVOO)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10 000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'University Hospital for Infectious Diseases "Dr Fran Mihaljevic"', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}], 'overallOfficials': [{'name': 'Josip Begovac, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital for Infectious Diseases "Dr Fran Mihaljevic" Zagreb, Croatia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital for Infectious Diseases, Croatia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Josip Begovac, MD, PhD, professor in infectious diseases', 'oldOrganization': 'University Hospital for Infectious Diseases "Dr Fran Mihaljevic"'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-07-28', 'type': 'RELEASE'}, {'date': '2011-08-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University Hospital for Infectious Diseases, Croatia'}}}}