Effect of Extra Virgin Olive Oil on Atherosclerosis Biomarkers in HIV-infected Patients (EVOO_HIV)
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|ClinicalTrials.gov Identifier: NCT00925795|
Recruitment Status : Completed
First Posted : June 22, 2009
Last Update Posted : November 23, 2010
|Condition or disease||Intervention/treatment||Phase|
|HIV Atherosclerosis HIV Infections||Other: consumption 1. EVOO; 2. ROO Other: consumption 1. ROO; 2. EVOO||Not Applicable|
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.
A 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.
As 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Effect of Extra Virgin Olive Oil on Atherosclerosis Biomarkers in Patients Treated With Combination Antiretroviral Therapy: a Randomized, Crossover Trial|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||October 2010|
|Active Comparator: Group A (1. EVOO; 2. ROO)||
Other: consumption 1. EVOO; 2. ROO
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
Other Name: olive oil
|Active Comparator: Group B (1. ROO; 2. EVOO)||
Other: consumption 1. ROO; 2. EVOO
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
Other Name: olive oil
- To assess whether consumption of extra virgin olive oil (EVOO) leads to improvement of atherosclerosis biomarkers in persons receiving antiretroviral drugs. [ Time Frame: biomarker measurement before and after both intervention periods (20 days each) ]
- To assess which atherosclerosis biomarkers are the most affected (inflammation, hypercoagulability, dislipidemia, endothelial dysfunction or oxidative stress) by EVOO consumption [ Time Frame: biomarker measurement before and after both intervention periods (20 days each) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00925795
|University Hospital for Infectious Diseases "Dr Fran Mihaljevic"|
|Zagreb, Croatia, 10 000|
|Principal Investigator:||Josip Begovac, MD, PhD||University Hospital for Infectious Diseases "Dr Fran Mihaljevic" Zagreb, Croatia|