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

November 22, 2010 updated by: University Hospital for Infectious Diseases, Croatia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10 000
        • University Hospital for Infectious Diseases "Dr Fran Mihaljević"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • olive oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
biomarker measurement before and after both intervention periods (20 days each)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
biomarker measurement before and after both intervention periods (20 days each)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital for Infectious Diseases, Croatia

Investigators

  • Principal Investigator: Josip Begovac, MD, PhD, University Hospital for Infectious Diseases "Dr Fran Mihaljevic" Zagreb, Croatia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

June 19, 2009

First Submitted That Met QC Criteria

June 19, 2009

First Posted (Estimate)

June 22, 2009

Study Record Updates

Last Update Posted (Estimate)

November 23, 2010

Last Update Submitted That Met QC Criteria

November 22, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHID-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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