]>
IRCT2017020412438N22 IRCT 2017-04-21 Kashan University of Medical Sciences Effect of Omega-3 fatty acid on patients with coronary heart disease A comparison between the effects of flaxseed oil and fish oil supplementation on cardiovascular health in type 2 diabetic patients with coronary heart disease 2017-01-01 anticipated 90 Complete https://irct.ir/trial/12510 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Coronary Heart Disease. Intervention 1: Intervention group: Omega-3 fatty acid (flaxseed oil) pearl, 1000 mg, BID, for 3 months orally. Intervention 2: Intervention group: Omega-3 fatty acid (fish oil) pearl, 1000 mg, BID, for 3 months orally. Intervention 3: control group: placebo pearl, 1000 mg, BID, for 3 months orally. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available
public Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 1771844351 +98 31 5554 0021 asemi_z@kaums.ac.ir Kashan University of Medical Sciences scientific Zatollah Asemi
Kashan University Of Medical Sciences, Kashan
Kashan Iran (Islamic Republic of) 1771844351 +98 31 5554 0021 asemi_z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Inclusion Criteria: Subjects aged 40-100 years Patients diagnosed with type 2 diabetes and coronary heart disease 40 years 100 years Both 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 I25.9 Chronic ischemic heart disease, unspecified Treatment - Drugs Treatment - Drugs Placebo Intervention group: Omega-3 fatty acid (flaxseed oil) pearl, 1000 mg, BID, for 3 months orally. Intervention group: 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. Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula. Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Weight. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: scale. BMI. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Formula. Kashan University of Medical Sciences Approved 2016-11-16 Ethics committee of Kashan University of Medical Sciences Kashan University Of Medical Sciences, Kashan Kashan Isfehan Iran (Islamic Republic of)