Comparison of Extra-Virgin and Refined Olive Oil on Some Cardiovascular Risk Factors
Comparison of Effects of Extra-virgin and Refined Olive Oil Consumption on Plasma Lipids and Inflammatory Markers in Patients Undergoing Coronary Angiography
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedFirst Posted
Study publicly available on registry
January 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedDecember 10, 2019
December 1, 2019
8 months
December 29, 2018
December 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Interleukin-6 (IL-6)
change in plasma level of interleukin-6 (IL-6) in pg/mL from baseline at week-6
6 week
Secondary Outcomes (4)
plasma lipid profile
6 week
plasma liver enzymes (SGOT & SGPT)
6 week
Interleukin-10 (IL-10)
6 week
C reactive protein (CRP)
6 week
Study Arms (2)
Extra-Virgin Olive Oil
ACTIVE COMPARATORDaily consumption of 25 mL Extra-Virgin Olive Oil for 6 weeks
Refined Olive Oil
PLACEBO COMPARATORDaily consumption of 25 mL Refined Olive Oil for 6 weeks
Interventions
Daily consumption of 25 mL Extra-Virgin Olive Oil in adjunct to medical treatment for 6 weeks
Daily consumption of 25 mL Refined Olive Oil in adjunct to medical treatment for 6 weeks
Eligibility Criteria
You may qualify if:
- patients with at least one of the cardiovascular risk factors (hypertension, hyperlipidemia, diabetes mellitus) candidate for angiography
- willing to participation in the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rajaei Cardiovascular, Medical & Research Center
Tehran, Iran
Related Publications (1)
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.
PMID: 33121297DERIVED
Study Officials
- STUDY CHAIR
Javad Nasrollahzadeh, Ph.D
Shahid Beheshti University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Investigator in Clinical Nutrition
Study Record Dates
First Submitted
December 29, 2018
First Posted
January 8, 2019
Study Start
January 1, 2019
Primary Completion
September 1, 2019
Study Completion
October 1, 2019
Last Updated
December 10, 2019
Record last verified: 2019-12