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
  Purpose

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.


Condition Intervention
HIV
Atherosclerosis
HIV Infections
Other: consumption 1. EVOO; 2. ROO
Other: consumption 1. ROO; 2. EVOO

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effect of Extra Virgin Olive Oil on Atherosclerosis Biomarkers in Patients Treated With Combination Antiretroviral Therapy: a Randomized, Crossover Trial

Resource links provided by NLM:


Further study details as provided by University Hospital for Infectious Diseases, Croatia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 39
Study Start Date: September 2009
Study Completion Date: October 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00925795

Locations
Croatia
University Hospital for Infectious Diseases "Dr Fran Mihaljevic"
Zagreb, Croatia, 10 000
Sponsors and Collaborators
University Hospital for Infectious Diseases, Croatia
Investigators
Principal Investigator: Josip Begovac, MD, PhD University Hospital for Infectious Diseases "Dr Fran Mihaljevic" Zagreb, Croatia
  More Information

Publications:
Responsible Party: Josip Begovac, MD, PhD, professor in infectious diseases, University Hospital for Infectious Diseases "Dr Fran Mihaljevic"
ClinicalTrials.gov Identifier: NCT00925795     History of Changes
Other Study ID Numbers: UHID-01
Study First Received: June 19, 2009
Last Updated: November 22, 2010
Health Authority: Croatia: Ministry of Health and Social Care

Keywords provided by University Hospital for Infectious Diseases, Croatia:
HIV
atherosclerosis
extra virgin olive oil
Alternative therapies
Treatment experienced+

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Atherosclerosis
Arteriosclerosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014