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

Cardiovascular Risk Factor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03796780
• Other study ID #: 425
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: October 1, 2019

Study information

• Verified date: December 2019
• Source: Shahid Beheshti University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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]).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

Dietary Supplement:
• Extra-Virgin Olive Oil
Daily consumption of 25 mL Extra-Virgin Olive Oil in adjunct to medical treatment for 6 weeks
• Refined Olive Oil
Daily consumption of 25 mL Refined Olive Oil in adjunct to medical treatment for 6 weeks

Locations

Country	Name	City	State
Iran, Islamic Republic of	Rajaei Cardiovascular, Medical & Research Center	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Javad Nasrollahzadeh	Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

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