A comparison between the effects of flaxseed oil and fish oil supplementation on cardiovascular health in type 2 diabetic patients with coronary heart disease
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General information
2017-04-21, 1396/02/01
2017-01-01, 1395/10/12
2017-0401-2101 00:00:00
2018-04-21, 1397/02/01
2017-01-30, 1395/11/11
20182017-0401-2130 00:00:00
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The revisions were accordance with the original approved proposal and with coordination with Vice Chancellor of Research at the University.
The revisions were accordance with the original approved proposal and with coordination with Vice Chancellor of Research at the University.
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اصلاحات صورت گرفته مطابق با پروپوزال اصلی تصویب شده و با هماهنگی معاونت پژوهشی دانشگاه بود.
اصلاحات صورت گرفته مطابق با پروپوزال اصلی تصویب شده و با هماهنگی معاونت پژوهشی دانشگاه بود.
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Protocol summary
Study aim
Objective: The aim of this study is to compare the effects of flaxseed oil and fish oil supplementation on cardiovascular health in type 2 diabetic patients with coronary heart disease.
Design
Study design: Randomized double-blind placebo-controlled trial. To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<65 and ≥65 y). Then, participants in each block will be randomly allocated into three groups to take either supplements or placebo. Randomization will be done by the use of computer software.
Settings and conduct
Among patients with CHD referred to cardiology Clinic affiliated to Kashan University of Medical Sciences, 90 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Subjects aged 40-100 years diagnosed with type 2 diabetes and coronary heart disease. Exclusion Criteria: Individuals consuming omega-3 supplements within the last 3 months, having an acute myocardial infarction or cardiac surgery within the past 3 months.
Intervention groups
Intervention group 1: Omega-3 fatty acid (flaxseed oil) pearl, 1000 mg, BID, for 3 months orally. Intervention group 2: Omega-3 fatty acid (fish oil) pearl, 1000 mg, BID, for 3 months orally. control group: placebo pearl, 1000 mg, BID, for 3 months orally.
Main outcome variables
Outcomes: Insulin resistance (primary outcomes) and lipid profile, weight, BMI, biomarkers of inflammation and oxidative stress (secondary outcomes) will be quantified at study baseline and end-of-trial
General information
Reason for update
The revisions were accordance with the original approved proposal and with coordination with Vice Chancellor of Research at the University.
Acronym
IRCT registration information
IRCT registration number:IRCT2017020412438N22
Registration date:2017-04-21, 1396/02/01
Registration timing:retrospective
Last update:2020-12-02, 1399/09/12
Update count:2
Registration date
2017-04-21, 1396/02/01
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij Research Center of Medicinal Herbs
Expected recruitment start date
2017-01-01, 1395/10/12
Expected recruitment end date
2017-01-30, 1395/11/11
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
A comparison between the effects of flaxseed oil and fish oil supplementation on cardiovascular health in type 2 diabetic patients with coronary heart disease
Public title
Effect of Omega-3 fatty acid on patients with coronary heart disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion Criteria: Subjects aged 40-100 years
Patients diagnosed with type 2 diabetes and coronary heart disease
Exclusion criteria:
Exclusion Criteria: Individuals consuming omega-3 supplements within the last 3 months
having an acute myocardial infarction or cardiac surgery within the past 3 months
Age
From 40 years old to 100 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<65 and ≥65 y). Then, participants in each block will be randomly allocated into three groups to take either supplements or placebo. Randomization will be done by the use of computer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the cardiology clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of supplements
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
Approval date
2016-11-16, 1395/08/26
Ethics committee reference number
IR.KAUMS.REC.1395.84
Health conditions studied
1
Description of health condition studied
Coronary Heart Disease
ICD-10 code
I25.9
ICD-10 code description
Chronic ischemic heart disease, unspecified
Primary outcomes
1
Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula
Secondary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
2
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
6
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
7
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
8
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
9
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
10
Description
Weight
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
scale
11
Description
BMI
Timepoint
At the beginning of the study and after 12 weeks of intervention