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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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
Design
A single center, randomized, not blinded, controlled clinical trial with a parallel group design of 40 participants
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
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
Public title
Comparison of effects of refined olive oil and canola in patients referred for coronary angiography
Purpose
Supportive
Inclusion/Exclusion criteria
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
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthics Committee of Shahid Beheshti University of Medical Sciences
Street address
No. 46, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2018-03-13, 1396/12/22
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1396.203
Health conditions studied
1
Description of health condition studied
Coronary Artery Disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery