HIVEVOO_HIVNCT00925795
Effect of Extra Virgin Olive Oil on Atherosclerosis Biomarkers in HIV-infected Patients
A study testing consumption 1. EVOO; 2. ROO and consumption 1. ROO; 2. EVOO in people with HIV and Atherosclerosis, run by University Hospital for Infectious Diseases, Croatia at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HIV, Atherosclerosis, HIV Infections
- What is being tested?
- consumption 1. EVOO; 2. ROO and consumption 1. ROO; 2. EVOO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteCroatia
- Study dates
- Sep 2009to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnant HIV-positive women
- HIV-patients with underlying acute/chronic diseases (except cardiovascular)
Trial locations and contacts
1 site in 1 country.
Croatia1 site
University Hospital for Infectious Diseases "Dr Fran Mihaljevic"
Zagreb, 10 000
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV, Atherosclerosis, HIV Infections
- Being tested
- consumption 1. EVOO; 2. ROO, consumption 1. ROO; 2. EVOO
- Keywords
- HIV, atherosclerosis, extra virgin olive oil, Alternative therapies, Treatment experienced+
- Medical subject headings
- Atherosclerosis, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
consumption 1. EVOO; 2. ROOOther
Also called olive oil
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
consumption 1. ROO; 2. EVOOOther
Also called olive oil
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
| Study group | Role | What they receive |
|---|---|---|
| Group A (1. EVOO; 2. ROO) | Active comparator | Not described Receives: Other: consumption 1. EVOO; 2. ROO |
| Group B (1. ROO; 2. EVOO) | Active comparator | Not described Receives: Other: consumption 1. ROO; 2. EVOO |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether consumption of extra virgin olive oil (EVOO) leads to improvement of atherosclerosis biomarkers in persons receiving antiretroviral drugs.
Measured: 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
Measured: biomarker measurement before and after both intervention periods (20 days each)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital for Infectious Diseases, Croatia
- Sponsor type
- University, hospital or other
- Investigators
- Josip Begovac, MD, PhD, Principal investigator, University Hospital for Infectious Diseases "Dr Fran Mihaljevic" Zagreb, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925795
- Sponsor's protocol ID
- UHID-01
- Acronym
- EVOO_HIV
- Status last verified
- Nov 2010
- First submitted
- 19 Jun 2009
- Last updated
- 23 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17321749Perona 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.
PubMed 16481154Covas 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.
PubMed 16954359Mehta 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.
PubMed 15765307Francisci 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.
PubMed 19177019Kozic 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.
PubMed 26280823
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extra Virgin Olive Oil on Atherosclerosis Biomarkers in Patients Treated With Combination Antiretroviral Therapy: a Randomized, Crossover Trial
- ClinicalTrials.gov ID
- NCT00925795
- Acronym / sponsor ID
- EVOO_HIV / UHID-01
- Conditions
- HIV, Atherosclerosis, HIV Infections
- Keywords
- HIV, atherosclerosis, extra virgin olive oil, Alternative therapies, Treatment experienced+
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Hospital for Infectious Diseases, CroatiaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 22 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (1. EVOO; 2. ROO) | Active comparator | Other: consumption 1. EVOO; 2. ROO |
| Group B (1. ROO; 2. EVOO) | Active comparator | Other: consumption 1. ROO; 2. EVOO |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- pregnant HIV-positive women
- HIV-patients with underlying acute/chronic diseases (except cardiovascular)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| consumption 1. EVOO; 2. ROOAlso: olive oilEVOO 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 | Group A (1. EVOO; 2. ROO) |
| consumption 1. ROO; 2. EVOOAlso: olive oilROO 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 | Group B (1. ROO; 2. EVOO) |
Primary outcome
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)
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2010.
- Background: PubMed 17321749Covas 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.
- Background: PubMed 16481154Perona 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.
- Background: PubMed 16954359Covas 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.
- Background: PubMed 15765307Mehta 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.
- Background: PubMed 19177019Francisci 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.
- Derived from this study: PubMed 26280823Kozic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josip Begovac, MD, PhD principal investigator
University Hospital for Infectious Diseases "Dr Fran Mihaljevic" Zagreb, Croatia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing consumption 1. EVOO; 2. ROO and consumption 1. ROO; 2. EVOO in people with HIV and Atherosclerosis, run by University Hospital for Infectious Diseases, Croatia at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00925795, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2010.