Clinical trial NCT03796780: Comparison of Extra-Virgin and Refined Olive Oil on Some Cardiovascular Risk Factors
Official title: Comparison of Effects of Extra-virgin and Refined Olive Oil Consumption on Plasma Lipids and Inflammatory Markers in Patients Undergoing Coronary Angiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
First posted: 2019-01-08
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 \[CRP\]).

Eligibility criteria: 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

Primary outcomes:
measure: Interleukin-6 (IL-6)
timeFrame: 6 week
Secondary outcomes:
measure: plasma lipid profile
timeFrame: 6 week
measure: plasma liver enzymes (SGOT & SGPT)
timeFrame: 6 week
measure: Interleukin-10 (IL-10)
timeFrame: 6 week
measure: C reactive protein (CRP)
timeFrame: 6 week
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Rajaei Cardiovascular, Medical & Research Center
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Javad Nasrollahzadeh, Ph.D
role: STUDY_CHAIR
References:
citation: 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.