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Effect of Extra Virgin Olive Oil on Atherosclerosis Biomarkers in HIV-infected Patients (EVOO_HIV)

This study has been completed.
Sponsor:
Information provided by:
University Hospital for Infectious Diseases, Croatia
ClinicalTrials.gov Identifier:
NCT00925795
First received: June 19, 2009
Last updated: November 22, 2010
Last verified: November 2010

June 19, 2009
November 22, 2010
September 2009
August 2010   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00925795 on ClinicalTrials.gov Archive Site
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) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Extra Virgin Olive Oil on Atherosclerosis Biomarkers in HIV-infected Patients
Effect of Extra Virgin Olive Oil on Atherosclerosis Biomarkers in Patients Treated With Combination Antiretroviral Therapy: a Randomized, Crossover Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • HIV
  • Atherosclerosis
  • HIV Infections
  • 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
  • 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
  • Active Comparator: Group A (1. EVOO; 2. ROO)
    Intervention: Other: consumption 1. EVOO; 2. ROO
  • Active Comparator: Group B (1. ROO; 2. EVOO)
    Intervention: Other: consumption 1. ROO; 2. EVOO

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
October 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • pregnant HIV-positive women
  • HIV-patients with underlying acute/chronic diseases (except cardiovascular)
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Croatia
 
NCT00925795
UHID-01
Yes
Josip Begovac, MD, PhD, professor in infectious diseases, University Hospital for Infectious Diseases "Dr Fran Mihaljevic"
University Hospital for Infectious Diseases, Croatia
Not Provided
Principal Investigator: Josip Begovac, MD, PhD University Hospital for Infectious Diseases "Dr Fran Mihaljevic" Zagreb, Croatia
University Hospital for Infectious Diseases, Croatia
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP