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

Javad Nasrollahzadeh40 enrolled

Overview

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 \[CRP\]).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cardiovascular Risk Factor

Interventions

Extra-Virgin Olive OilDIETARY_SUPPLEMENT

Daily consumption of 25 mL Extra-Virgin Olive Oil in adjunct to medical treatment for 6 weeks

Refined Olive OilDIETARY_SUPPLEMENT

Daily consumption of 25 mL Refined Olive Oil in adjunct to medical treatment for 6 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Rajaei Cardiovascular, Medical & Research Center

Tehran, Iran

Outcomes

Primary Outcomes

Interleukin-6 (IL-6)

change in plasma level of interleukin-6 (IL-6) in pg/mL from baseline at week-6

Time frame: 6 week

Secondary Outcomes

plasma lipid profile

change in plasma level of lipoproteins in mg/dL from baseline at 6 week

Time frame: 6 week

plasma liver enzymes (SGOT & SGPT)

change in plasma level of liver enzymes (SGOT \& SGPT) in mg/dL from baseline at 6 week

Time frame: 6 week

Interleukin-10 (IL-10)

Change in plasma level of interleukin-10 (IL-10) in pg/mL at baseline and week-6

Time frame: 6 week

C reactive protein (CRP)

Change in plasma level of C reactive protein (CRP) in mg/dL from baseline and week-6

Time frame: 6 week

Data from ClinicalTrials.gov

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