This randomized, double-blind, controlled clinical trial will be done on a total of 44 coronary artery disease (CAD) patients. Participants will be divided randomly into intervention and placebo groups. The CAD will be defined as presence of ≥1 stenotic coronary arteries with at least 50% stenosis confirmed by coronary angiography among subjects referring to Madani University hospital, Tabriz, Iran. The participants with 30-65 years old and BMI at the range of 25-35 will be included. Patients with other cardiovascular or chronic diseases will be excluded. To minimize the effect of confounders, matching will be applied for age, sex, BMI and any current anti-hyperlipidemic and anti-hypertensive medications . All the Subjects will be receiving a moderate calorie restricted dietary plan. They will be requested to consume 200 ml of milk prepared with 1.5% fat+ 2% flaxseed oil (containing 2 g alpha linolenic acid) or 1.5% fat milk for eight consecutive weeks. Food intake will be assessed using 3 days food record method at the beginning and end of the study. After 10-12 h fasting, 4 ml blood will be taken to evaluate primary outcomes. informed consent form will be fulfilled prior to start of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017102811288N13
Registration date:2017-11-01, 1396/08/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-11-01, 1396/08/10
Registrant information
Name
Mohammad Alizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7313
Email address
mdalizadeh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University Of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of flaxseed oil supplementation on some inflammatory factors level in Patients with Coronary Artery Disease
Public title
Effect of flaxseed oil supplementation on some inflammatory factors level in Patients with Coronary Artery Disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Subjects with 30-65 years old; BMI equal 25-35 kg/m2, angiographically confirmed coronary artery disease with more than 50% stenosis of at least one of the major coronary vessels; ٍExclusion criteria: Heart failure (function class III and IV), Heart valve diseases; Diabetes dependent on insuline therapy or any other chronic disease; Consumption of any immunosuppressive drugs; Antioxidant and/or vitamin supplements; Fish oil or (n-3) fatty acid supplements; Weight loss drugs or weight loss surgery; Smoking and drug users; Pregnant and lactating women; Those with Lactase deficiency ( milk intolerance)
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Of Medical Sciences
Street address
Golghasht St,
City
Tabriz
Postal code
Approval date
2017-09-18, 1396/06/27
Ethics committee reference number
IR.TBZMED.REC.1396.613
Health conditions studied
1
Description of health condition studied
Coronary Artery Disease
ICD-10 code
170
ICD-10 code description
Atherosclerosis
Primary outcomes
1
Description
Serum Levels Of MMP-9
Timepoint
Pre And Post Intervention
Method of measurement
ELISA Kit
2
Description
Serum Levels Of MCP-1
Timepoint
Pre And Post Intervention
Method of measurement
ELISA Kit
Secondary outcomes
1
Description
Energy And Macronutrient Levels
Timepoint
Pre And Post Intervention
Method of measurement
Food Record Questionnaire
2
Description
Physical Activity Level
Timepoint
Pre And Post Intervention
Method of measurement
International Physical Activity Questionnaire
Intervention groups
1
Description
Intervention Group|: 200 ml Of Milk Prepared With 1.5% Fat+ 2 % Flaxseed Oil (containing 2 g alpha linolenic acid)/day For 2 Months
Category
Lifestyle
2
Description
Control Group: 200 ml Of milk contained 1.5% fat/ Day For 2 Mounths
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital, Tabriz
Full name of responsible person
Dr. Mohammad Alizadeh
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Office Of The Vice Chancellor For Research Of Tabriz University Of Medical Sciences
Full name of responsible person
Dr. Rashidi
Street address
Vice Chancellor for Research No 2 Central Building, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Office Of The Vice Chancellor For Research Of Tabriz 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 And Food Science, Tabriz University Of Medical Sciences
Full name of responsible person
Sevda Saleh- Ghadimi
Position
Ph.D. Candidate Of Nutrition Science
Other areas of specialty/work
Street address
Golgasht St
City
Tabriz
Postal code
Phone
+98 41 3381 1902
Fax
Email
salehghadimisevda@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty Of Nutrition And Food Science, Tabriz University Of Medical Sciences
Full name of responsible person
Dr. Mohammad Alizadeh
Position
MD, PhD
Other areas of specialty/work
Street address
Golgasht St
City
Tabriz
Postal code
Phone
+98 41 3335 7581
Fax
Email
salehghadimisevda@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Sevda Saleh-Ghadimi
Position
Other areas of specialty/work
Street address
City
Tabriz
Postal code
Phone
+98 41 3381 1902
Fax
Email
salehghadimisevda@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)