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
-
-
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
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
-
Method of measurement
-
Formula
Intervention groups
1
-
Description
-
Intervention group: Omega-3 fatty acid (flaxseed oil) pearl, 1000 mg, BID, for 3 months orally.
-
Category
-
Treatment - Drugs
2
-
Description
-
Intervention group: Omega-3 fatty acid (fish oil) pearl, 1000 mg, BID, for 3 months orally.
-
Category
-
Treatment - Drugs
3
-
Description
-
control group: placebo pearl, 1000 mg, BID, for 3 months orally.
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Kashan University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available