Protocol summary
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Study aim
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Comparison of effects of refined olive oil or canola oil consumption on plasma lipids and inflammatory cytokines secretion of whole blood culture in patients referred for coronary angiography
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Design
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A single center, randomized, not blinded, controlled clinical trial with a parallel group design of 40 participants
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Settings and conduct
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40 patients with at least one cardiovascular risk factor, referred for angiography in Rajaee hospital, will be randomized into two groups, refined olive oil (25 mL refined olive oil per day) or canola oil (25 mL canola oil) for 6 weeks. Plasma concentration of lipoproteins and lipoprotein phospholipase A2, and IL-6 and MCP-1 concentration in cultured whole blood are measured.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria:
1) Existence of at least one of the major cardiovascular risk factors
2) Willingness to participate in the study
3) Aged 20-75 years
4) No continuous consumption of any anti-inflammatory and antioxidant supplement such as omega-3, vitamin E, vitamin C and Selenium in last month
َExclusion Criteria:
1) Unwillingness to cooperation
2) Advanced hepatic or renal disease
3) Existence of gastrointestinal complications such as diarrhea
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Intervention groups
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1) Refined olive oil (intervention)
2) Canola oil (control)
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Main outcome variables
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lipoprotein phospholipase A2 (Lp-PLA2)
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160702028742N5
Registration date:
2019-04-19, 1398/01/30
Registration timing:
retrospective
Last update:
2021-01-06, 1399/10/17
Update count:
1
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Registration date
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2019-04-19, 1398/01/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-01-01, 1397/10/11
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Expected recruitment end date
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2019-04-19, 1398/01/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of effect of refined olive oil with canola oil consumption on plasma lipids and inflammatory cytokines secretion of whole blood culture in patients referred for coronary angiography
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Public title
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Comparison of effects of refined olive oil and canola in patients referred for coronary angiography
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Existence of at least one of the major cardiovascular risk factors
Willingness to participate in the study
No consumption of any anti-inflammatory or antioxidant supplement such as omega-3, vitamin E, vitamin C and Selenium in last month
Exclusion criteria:
Unwillingness to continue
Any changes in disease treatment plan such as changes in medical treatment or surgery
Existence of gastrointestinal complications such as diarrhea
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Age
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From 20 years old to 75 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization method (the easiest method of randomization) using a random numbers table
Random numbers table is a list of numbers, composed of the digits 0-9. Numbers in the list are arranged randomly, means that each number has no predictable relationship to the numbers that preceded it or to the numbers that followed it. At first, each member of study population (patients) has been assigned a number. Then, as regard to required sample size, it is randomly started from a point, moved systematically based on previous decision to the right, left, up or down, and the next number is selected. Based on previous decision, odd and even numbers are placed in the control and intervention groups, respectively. The random number allocation was concealed from the researcher and participants.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-03-13, 1396/12/22
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Ethics committee reference number
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IR.SBMU.NNFTRI.REC.1396.203
Health conditions studied
1
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Description of health condition studied
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Coronary Artery Disease
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ICD-10 code
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I25.1
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ICD-10 code description
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Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
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Description
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lipoprotein-associated phospholipase A2 (Lp-PLA2)
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Timepoint
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Baseline and the end of the study
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Method of measurement
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ELISA
Secondary outcomes
1
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Description
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Plasma Lipoproteins
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Timepoint
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Baseline and the end of the study
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Method of measurement
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colorimetry
2
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Description
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Interleukin-6 (IL-6) & Monocyte Chemoattractant Protein-1 (MCP-1) in cultured whole blood
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Timepoint
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Baseline and the end of the study
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Method of measurement
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ELISA
Intervention groups
1
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Description
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Intervention group: Daily consumption of 25 mL of pure canola oil as cold with meals for 6 weeks
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Category
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Lifestyle
2
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Description
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Intervention group: Daily consumption of 25 mL of refined olive oil as cold with meals for 6 weeks
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
Trial results
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Please tick if results have been published
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Yes
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Summary result posting date
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2021-01-06, 1399/10/17
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Table of baseline comparison
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Participant flow diagram
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Table of variable outcomes' results
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Table of adverse events
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First publication date
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empty
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Abstract of published paper
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