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IRCT20190819044563N1 IRCT 2019-11-10 Oroumia University of Medical Sciences Assessment the Effect of omega 3 supplementation on Improving Metabolic Syndrome indices Assessment the Effect of omega 3 supplementation on Improving Metabolic Syndrome indices in Patients with Ischemic heart disease 2019-09-23 anticipated 90 Complete https://irct.ir/trial/41720 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be divided into two groups according to the stratified block randomization method, Blinding description: Participants are unaware of either the intervention group or the control group. Also, the clinical researcher and outcome assessor do not know which individuals are in the intervention and control groups. Only the statistical expert who randomly divided the subjects into two groups is aware of the status of the individuals and who is in the intervention group and who is in the control group. 3 Metabolic syndrome. Intervention 1: Intervention group: Intervention group given daily omega-3 supplement in the form of 1000 mg gel made by Zahravi Pharmaceutical Company of Tabriz. Intervention 2: Control group: Omega-3 supplemented placebo control group given by Tabriz Zahravi Pharmaceutical Company. 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 No more information
public Asma Zamanian
Kosar Dormitory,Urmia University of Medical Sciences,Nazlou, Serow Road
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 4897 asma_wzm@yahoo.com Oroumia University of Medical Sciences scientific Asma Zamanian
Kosar Dormitory,Urmia University of Medical Sciences,Nazlou, Serow Road
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 4897 asma_wzm@yahoo.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Interested in attending the study who have completed and signed the informed consent form. Metabolic syndrome according to existing criteria, including: There are 3 of the following: Waist circumference ≥ 80 cm for women and Waist circumference ≥ 94 cm for men, fasting blood glucose ≥ 100 mg / dl , Systolic blood pressure ≥ 130 and diastolic blood pressure above ≥ 85 , mm Hg, HDL less than 50 mg / dL for women and less than 40 mg / dL for men and triglycerides; 150 mg / dL and drug administration for triglycerides Blood glyceride, cholesterol and LDL (including statins, etc.). With ischemic heart disease. no limit no limit Both Mental, emotional, cognitive, or any disorders that may prevent a person from participating in this study. People who have certain dietary restrictions and follow a specific diet. autoimmune diseases (corticosteroids), cancer alcohol consumption Pregnancy Breastfeeding Infectious Diseases Chronic Kidney Disease Liver disease Food intolerance and sensitivity to fish Drug abuse Anticoagulants such as warfarin Changes in the level of physical activity during the study People taking Omega-3 supplements Consume more than one serving of fish per week Omega-3 sensitivity cases E88.81 Metabolic syndrome Treatment - Drugs Treatment - Drugs Intervention group: Intervention group given daily omega-3 supplement in the form of 1000 mg gel made by Zahravi Pharmaceutical Company of Tabriz Control group: Omega-3 supplemented placebo control group given by Tabriz Zahravi Pharmaceutical Company Triglyceride. Timepoint: Blood triglyceride levels at baseline (before intervention) and at the end of the study at week 12. Method of measurement: Serum triglyceride concentration measurement by enzymatic method with BT1500. High-density lipoprotein. Timepoint: Blood High-density lipoprotein levels at baseline (before intervention) and at the end of the study at week 12. Method of measurement: Serum high-density lipoprotein concentration measurement by enzymatic method with BT1500. Low-density lipoprotein. Timepoint: Blood Low-density lipoprotein levels at baseline (before intervention) and at the end of the study at week 12. Method of measurement: Serum low-density lipoprotein concentration measurement by enzymatic method with BT1500. Fasting blood sugar. Timepoint: Blood Fasting blood sugar levels at baseline (before intervention) and at the end of the study at week 12. Method of measurement: Serum fasting blood sugar concentration measurement by enzymatic method with BT1500. Total cholesterol. Timepoint: Blood Total cholesterol levels at baseline (before intervention) and at the end of the study at week 12. Method of measurement: Serum total cholesterol concentration measurement by enzymatic method with BT1500. Waist circumference. Timepoint: Waist measurement at baseline (before intervention) and at weeks 4, 8 and end of study at week 12. Method of measurement: Using meters and in centimeters. Weight. Timepoint: Weight measurement at baseline (before intervention) and at 4, 8 and 12 weeks. Method of measurement: The weight of a person with minimal clothing and no shoes is measured to the nearest 100 grams. Body Mass Index. Timepoint: Body Mass Index measurement at baseline (before intervention) and at 4, 8 and 12 weeks. Method of measurement: Using the values of height and weight and by the formula of weight divided by the square of height in meters. Physical activity. Timepoint: Physical activity measurement at baseline (before intervention) and at 4, 8 and 12 weeks. Method of measurement: Measurement of physical activity at three levels of light, moderate and vigorous using the International Physical Activity Questionnaire. Systolic blood pressure. Timepoint: Systolic blood pressure measurement at baseline (before intervention) and at 4, 8 and 12 weeks. Method of measurement: Using a calibrated digital barometer. Diastolic blood pressure. Timepoint: Diastolic blood pressure measurement at baseline (before intervention) and at 4, 8 and 12 weeks. Method of measurement: Using a calibrated digital barometer. Feed Frequency Questionnaire. Timepoint: Feed Frequency Questionnaire at the beginning of the study (before the intervention) and at the end of the 12 week study. Method of measurement: Using a food frequency questionnaire. Height. Timepoint: Measurement of individuals height at baseline (before intervention). Method of measurement: Using the height gauge. Oroumia University of Medical Sciences Approved 2019-08-19 Ethics committee of Urmia University of Medical Sciences Department of Nutrition, Faculty of Medicine, Urmia University of Medical Sciences, Sero Highway, Urmia, Iran Urmia West Azarbaijan Iran (Islamic Republic of)