MedDataX Logo

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

NCT ID: NCT00925795

Last Updated: 2010-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Atherosclerosis HIV Infections

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

HIV atherosclerosis extra virgin olive oil Alternative therapies Treatment experienced+

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A (1. EVOO; 2. ROO)

Group Type ACTIVE_COMPARATOR

consumption 1. EVOO; 2. ROO

Intervention Type OTHER

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

Group B (1. ROO; 2. EVOO)

Group Type ACTIVE_COMPARATOR

consumption 1. ROO; 2. EVOO

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

olive oil olive oil

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital for Infectious Diseases, Croatia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University Hospital for Infectious Diseases "Dr Fran Mihaljevic"

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Josip Begovac, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital for Infectious Diseases "Dr Fran Mihaljevic" Zagreb, Croatia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital for Infectious Diseases "Dr Fran Mihaljevic"

Zagreb, , Croatia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Croatia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 17321749 (View on PubMed)

Perona 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.

Reference Type BACKGROUND
PMID: 16481154 (View on PubMed)

Covas 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.

Reference Type BACKGROUND
PMID: 16954359 (View on PubMed)

Mehta 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.

Reference Type BACKGROUND
PMID: 15765307 (View on PubMed)

Francisci 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.

Reference Type BACKGROUND
PMID: 19177019 (View on PubMed)

Kozic 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.

Reference Type DERIVED
PMID: 26280823 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UHID-01

Identifier Type: -

Identifier Source: org_study_id