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

December 7, 2019 updated by: Javad Nasrollahzadeh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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]).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Javad Nasrollahzadeh

Collaborators

Shahid Beheshti University of Medical Sciences

Investigators

  • Study Chair: Javad Nasrollahzadeh, Ph.D, Shahid Beheshti University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

December 29, 2018

First Submitted That Met QC Criteria

January 4, 2019

First Posted (Actual)

January 8, 2019

Study Record Updates

Last Update Posted (Actual)

December 10, 2019

Last Update Submitted That Met QC Criteria

December 7, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 425

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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