Cardiovascular Risk Factor
Conditions
Brief summary
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
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 \[CRP\]).
Interventions
DIETARY_SUPPLEMENTExtra-Virgin Olive Oil
Daily consumption of 25 mL Extra-Virgin Olive Oil in adjunct to medical treatment for 6 weeks
DIETARY_SUPPLEMENTRefined Olive Oil
Daily consumption of 25 mL Refined Olive Oil in adjunct to medical treatment for 6 weeks
Sponsors
Shahid Beheshti University of Medical Sciences
Javad Nasrollahzadeh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. patients with at least one of the cardiovascular risk factors (hypertension, hyperlipidemia, diabetes mellitus) candidate for angiography 2. willing to participation in the study
Exclusion criteria
1. Continuous consumption of any supplement with anti-inflammatory or antioxidant properties such as Omega-3, vitamin E, vitamin C and Selenium in last month 2. َChronic kidney disease stage 5 3. Any change in disease treatment plan such as change in type and dose of lipid lowering drugs or surgical operation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interleukin-6 (IL-6) | 6 week | change in plasma level of interleukin-6 (IL-6) in pg/mL from baseline at week-6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| plasma lipid profile | 6 week | change in plasma level of lipoproteins in mg/dL from baseline at 6 week |
| plasma liver enzymes (SGOT & SGPT) | 6 week | change in plasma level of liver enzymes (SGOT & SGPT) in mg/dL from baseline at 6 week |
| Interleukin-10 (IL-10) | 6 week | Change in plasma level of interleukin-10 (IL-10) in pg/mL at baseline and week-6 |
| C reactive protein (CRP) | 6 week | Change in plasma level of C reactive protein (CRP) in mg/dL from baseline and week-6 |
Countries
Iran
Outcome results
None listed