Effect of Extra Virgin Olive Oil on Atherosclerosis Biomarkers in HIV-infected Patients
Condition: HIV; Atherosclerosis; HIV Infections
MeSH terms: Atherosclerosis
Study type: Interventional

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. 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.
    

Intervention name(s): consumption 1. EVOO; 2. ROO; consumption 1. ROO; 2. EVOO
Intervention type(s): Other; Other
Intervention description(s): 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; 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 intervention name(s): olive oil; olive oil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: HIV; atherosclerosis; extra virgin olive oil; Alternative therapies; Treatment experienced+