Objective: To examine the effect of flaxseed consumption on inflammation and vascular endothelial function markers in patients with coronary artery disease
Design: This study is a single center, not blinded, randomized clinical trial with two parallel groups in third phase.
In this study, 60 non smoker patients with coronary artery disease referred for angioplasty in Rajaee hospital, will be randomized into two groups, falxseed (30 gram of flaxseed per day) or placebo (1 gram of wheat fiber) for 3 months. Vascular endothelial function will be evaluated through measurement of flow mediated dilatation (FMD) in brachial artery via ultrasound sonography. Fasting blood sample will be taken at the baseline and the end of study to measure plasma level of C-reactive protein and inflammatory cytokines.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2017040328742N2
Registration date:2017-06-13, 1396/03/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-13, 1396/03/23
Registrant information
Name
Javad Nasrollahzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2236 0656
Email address
jnasrolah@razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of flaxseed consumption on inflammation and vascular endothelial function markers in coronary artery disease patients
Public title
Effect of flaxseed in patients with heart disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
1) coronary artery disease patients (more than 50% blockage in coronary arteries) needed angioplasty with stent
2) willing to participation in the study
َExclusion Criteria:
1) cigarette Smoking
2) continuous consumption of any antioxidant supplement such as vitamin E, vitamin C and Selenium in last month
3) consumption of flaxseed or any omega-3 supplement at the beginning of the study
4) َadvanced renal disease
5) unwillingness to continuance
6) any change in disease treatment plan such as change in type and dose of lipid lowering drugs or surgical operation
Age
From 20 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Type of randomization: simple (complete randomness of the assignment of a subject to a particular group) by an random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Rajaei Cardiovascular, Medical & Research Center
Street address
Niyayesh Conjunction, Valiasr Street, Tehran
City
Tehran
Postal code
Approval date
2016-12-07, 1395/09/17
Ethics committee reference number
rhc.ac.ir.rec.1395.30
Health conditions studied
1
Description of health condition studied
Coronary heart disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
Flow Mediated Dilatation (FMD)
Timepoint
Baseline and the end of the study
Method of measurement
Ultrasound Sonography
Secondary outcomes
1
Description
Blood inflammatory cytokines
Timepoint
At baseline and the end of the study
Method of measurement
ELISA
Intervention groups
1
Description
Control: Daily consumption of one capsule containing 1 gr wheat fiber for 3 months
Category
Lifestyle
2
Description
Intervention: Daily consumption of 30 gr flaxseed for 3 months
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee Cardiovascular, Medical & Research Center
Full name of responsible person
Street address
Niyayesh Conjunction, Valiasr Street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Morteza Abdollahi
Street address
No. 46, Hafezi St, Farahzadi Blvd, Qods Town, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Nutrition Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nafiseh Khandouzi
Position
Ph.D. Student
Other areas of specialty/work
Street address
No. 46, Hafezi St, Farahzadi Blvd, Qods Town, Tehran
City
Tehran
Postal code
Phone
+98 21 2207 7424
Fax
Email
khandozi_n@yahoo.com; n-khandouzi@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nutrition Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Javad Nasrollahzadeh
Position
Ph.D. in nutrition
Other areas of specialty/work
Street address
No. 46, Hafezi St, Farahzadi Blvd, Qods Town, Tehran
City
Tehran
Postal code
Phone
+98 21 2207 7424
Fax
Email
jnasrollahzadeh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nutrition, Shahid Beheshti University of Medical sciences
Full name of responsible person
Nafiseh Khandouzi
Position
Ph.D. Student
Other areas of specialty/work
Street address
No. 46, Hafezi St, Farahzadi Blvd, Qods Town, Tehran
City
Tehran
Postal code
Phone
+98 21 2207 7424
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)