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| Name | Class |
|---|---|
| Shahid Beheshti University of Medical Sciences | OTHER |
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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.
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]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extra-Virgin Olive Oil | Active Comparator | Daily consumption of 25 mL Extra-Virgin Olive Oil for 6 weeks |
|
| Refined Olive Oil | Placebo Comparator | Daily consumption of 25 mL Refined Olive Oil for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extra-Virgin Olive Oil | Dietary Supplement | Daily consumption of 25 mL Extra-Virgin Olive Oil in adjunct to medical treatment for 6 weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javad Nasrollahzadeh, Ph.D | Shahid Beheshti University of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rajaei Cardiovascular, Medical & Research Center | Tehran | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33121297 | Derived | Khandouzi N, Zahedmehr A, Nasrollahzadeh J. Effect of polyphenol-rich extra-virgin olive oil on lipid profile and inflammatory biomarkers in patients undergoing coronary angiography: a randomised, controlled, clinical trial. Int J Food Sci Nutr. 2021 Jun;72(4):548-558. doi: 10.1080/09637486.2020.1841123. Epub 2020 Oct 29. |
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| Refined Olive Oil | Dietary Supplement | Daily consumption of 25 mL Refined Olive Oil in adjunct to medical treatment for 6 weeks |
|
| 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 |