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Completed

NCT Number: NCT03796780

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

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.

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Key information

Conditions

Cardiovascular Risk Factor

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rajaei Cardiovascular, Medical & Research Center

Tehran, Iran

About this study

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]).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with at least one of the cardiovascular risk factors (hypertension, hyperlipidemia, diabetes mellitus) candidate for angiography
  • willing to participation in the study

Exclusion criteria

  • Continuous consumption of any supplement with anti-inflammatory or antioxidant properties such as Omega-3, vitamin E, vitamin C and Selenium in last month
  • َChronic kidney disease stage 5
  • Any change in disease treatment plan such as change in type and dose of lipid lowering drugs or surgical operation

Treatment and study plan

Extra-Virgin Olive Oil

Dietary Supplement

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

Refined Olive Oil

Dietary Supplement

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

Primary outcomes

  1. 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

Secondary outcomes

  1. plasma lipid profile

    Time frame: 6 week

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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Javad Nasrollahzadeh

Other

Collaborators

  • Shahid Beheshti University of Medical Sciences

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 8, 2019
Registry last updated
Dec 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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