Effect of Extra Virgin Olive Oil on Atherosclerosis Biomarkers in HIV-infected Patients
EVOO_HIV
1 other identifier
interventional
39
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv
Started Sep 2009
Shorter than P25 for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2009
CompletedFirst Posted
Study publicly available on registry
June 22, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedNovember 23, 2010
November 1, 2010
11 months
June 19, 2009
November 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess whether consumption of extra virgin olive oil (EVOO) leads to improvement of atherosclerosis biomarkers in persons receiving antiretroviral drugs.
biomarker measurement before and after both intervention periods (20 days each)
Secondary Outcomes (1)
To assess which atherosclerosis biomarkers are the most affected (inflammation, hypercoagulability, dislipidemia, endothelial dysfunction or oxidative stress) by EVOO consumption
biomarker measurement before and after both intervention periods (20 days each)
Study Arms (2)
Group A (1. EVOO; 2. ROO)
ACTIVE COMPARATORGroup B (1. ROO; 2. EVOO)
ACTIVE COMPARATORInterventions
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
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
Eligibility Criteria
You may qualify if:
- HIV-positive patients receiving antiretroviral drugs
- undetectable HIV viral load in plasma for at least 6 months (by high sensitive Amplicor HIV-1 Monitor, version 1.5)
- glucose level within reference range
You may not qualify if:
- pregnant HIV-positive women
- HIV-patients with underlying acute/chronic diseases (except cardiovascular)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital for Infectious Diseases "Dr Fran Mihaljevic"
Zagreb, 10 000, Croatia
Related Publications (6)
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: 17321749BACKGROUNDPerona 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: 16481154BACKGROUNDCovas 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: 16954359BACKGROUNDMehta 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: 15765307BACKGROUNDFrancisci 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: 19177019BACKGROUNDKozic 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.
PMID: 26280823DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Josip Begovac, MD, PhD
University Hospital for Infectious Diseases "Dr Fran Mihaljevic" Zagreb, Croatia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 19, 2009
First Posted
June 22, 2009
Study Start
September 1, 2009
Primary Completion
August 1, 2010
Study Completion
October 1, 2010
Last Updated
November 23, 2010
Record last verified: 2010-11