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

NCT ID: NCT03796780

Last Updated: 2019-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-10-01

Brief Summary

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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

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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 \[CRP\]).

Conditions

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Cardiovascular Risk Factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Extra-Virgin Olive Oil

Daily consumption of 25 mL Extra-Virgin Olive Oil for 6 weeks

Group Type ACTIVE_COMPARATOR

Extra-Virgin Olive Oil

Intervention Type DIETARY_SUPPLEMENT

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 for 6 weeks

Group Type PLACEBO_COMPARATOR

Refined Olive Oil

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Extra-Virgin Olive Oil

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

Intervention Type DIETARY_SUPPLEMENT

Refined Olive Oil

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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. ŮŽChronic 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role collaborator

Javad Nasrollahzadeh

OTHER

Sponsor Role lead

Responsible Party

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Javad Nasrollahzadeh

Investigator in Clinical Nutrition

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Javad Nasrollahzadeh, Ph.D

Role: STUDY_CHAIR

Shahid Beheshti University of Medical Sciences

Locations

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Rajaei Cardiovascular, Medical & Research Center

Tehran, , Iran

Site Status

Countries

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Iran

References

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Khandouzi N, Zahedmehr A, Nasrollahzadeh J. Effect of polyphenol-rich extra-virgin olive oil on lipid profile and inflammatory biomarkers in patients undergoing coronary angiography: a randomised, controlled, clinical trial. Int J Food Sci Nutr. 2021 Jun;72(4):548-558. doi: 10.1080/09637486.2020.1841123. Epub 2020 Oct 29.

Reference Type DERIVED
PMID: 33121297 (View on PubMed)

Other Identifiers

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425

Identifier Type: -

Identifier Source: org_study_id