Comparison of Extra-Virgin and Refined Olive Oil on Some Cardiovascular Risk Factors

Study Overview
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Brief Summary
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Consumption of extra-virgin olive oil has beneficial effects on cardiovascular risk factors. The purpose of this study is to compare the effects of extra-virgin olive oil and refined olive oil, in adjunct to conventional medical treatment, in improving liver enzymes, plasma lipid profile and inflammatory markers in patients with cardiovascular risk factors.

Detailed Description
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A randomized placebo controlled clinical trial will be conducted in Rajaie Cardiovascular Center in Tehran, Iran. After review of the inclusion and exclusion criteria and explanation of the design of the study, written consent form will be completed. The participants are 40 eligible patients, aged 20-75 years. Intervention group will be received 25 mL/d extra-virgin olive oil and control group will be received 25 mL/d refined olive oil for 6 weeks. Fasting blood sample will be taken to measure lipid profile, liver enzymes and inflammatory markers (Interleukine-6 [IL-6] and Interleukine-10 [IL-10] and C-Reactive Protein [CRP]).

Official Title
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Comparison of Effects of Extra-virgin and Refined Olive Oil Consumption on Plasma Lipids and Inflammatory Markers in Patients Undergoing Coronary Angiography

Conditions
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Cardiovascular Risk Factor

Intervention / Treatment
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* Dietary Supplement: Extra-Virgin Olive Oil
* Dietary Supplement: Refined Olive Oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with at least one of the cardiovascular risk factors (hypertension, hyperlipidemia, diabetes mellitus) candidate for angiography willing to participation in the study Exclusion Criteria: Continuous consumption of any supplement with anti-inflammatory or antioxidant properties such as Omega-3, vitamin E, vitamin C and Selenium in last month َChronic kidney disease stage 5 Any change in disease treatment plan such as change in type and dose of lipid lowering drugs or surgical operation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extra-Virgin Olive Oil<br>Daily consumption of 25 mL Extra-Virgin Olive Oil for 6 weeks | Dietary Supplement: Extra-Virgin Olive Oil<br>* Daily consumption of 25 mL Extra-Virgin Olive Oil in adjunct to medical treatment for 6 weeks<br>|
| Placebo Comparator: Refined Olive Oil<br>Daily consumption of 25 mL Refined Olive Oil for 6 weeks | Dietary Supplement: Refined Olive Oil<br>* Daily consumption of 25 mL Refined Olive Oil in adjunct to medical treatment for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin-6 (IL-6) | change in plasma level of interleukin-6 (IL-6) in pg/mL from baseline at week-6 | 6 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma lipid profile | change in plasma level of lipoproteins in mg/dL from baseline at 6 week | 6 week | 
| plasma liver enzymes (SGOT & SGPT) | change in plasma level of liver enzymes (SGOT & SGPT) in mg/dL from baseline at 6 week | 6 week | 
| Interleukin-10 (IL-10) | Change in plasma level of interleukin-10 (IL-10) in pg/mL at baseline and week-6 | 6 week | 
| C reactive protein (CRP) | Change in plasma level of C reactive protein (CRP) in mg/dL from baseline and week-6 | 6 week |