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IRCT20090822002365N19 IRCT 2018-02-26 Iran University of Medical Sciences The effect of quercetin supplement on patients with myocardial infarction The effect of quercetin supplement on inflammatory factors and quality of life in patients with myocardial infarction 2018-04-04 anticipated 88 Complete https://irct.ir/trial/29694 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: For randomization, the permuted block randomization will be used with quadruple blocks. According to the identified sample size of 88, 22 blocks will be produced by using the online site (www.sealedenvelope.com), Blinding description: In order to apply the concealment in the randomization process, unique codes, which is generated by the software, will be used on the drug boxes. By entering each individual into the study based on the produced sequence, the drug box in which the code is registered, will be assigned to the individual. During the research, the randomization list is held by the statistic consultant, and the participants, the project implementer and all those who participate in the measurement of the indicators will not be aware of the assigned groups. 3 myocardial infarction. Intervention 1: Intervention group: 44 men and women with myocardial infarction, each receive a daily dose of 500 milligrams of quercetin supplement after meal for 8 weeks. Intervention 2: Control group: 44 men and women with myocardial infarction, each receive a daily dose of 500 milligrams of placebo (containing lactose, cellulose and starch), which looks like to quercetin supplement, after meal for 8 weeks. Yes - There is a plan to make this available What will be shared: Only a part of the data will be shared, such as primary outcomes and Etc. When: The access period will be 6 months after the publication of the results. To whom: The obtained data from current study will be available only for researchers working in academic and scientific institutions. Conditions: Six months after the publication of this study papers, the obtained data will be available to the applicant researchers for further analysis. Where to obtain: Applicants can be contacted with corresponding author by e-mail or postal address to receive the requested data. Postal address: Nutrition Department, School of health, Iran University of Medical Science, Hemmat Expressway, Tehran Phone Number: 0098 2186704743 E-mail: rezavafa@yahoo.com How to obtain: Applicants will be able to access the obtained data from current study by sending an email to the corresponding author up to one week. Comments:
public Mohammadreza Vafa
Nutrition Department, School of Health, Iran University of Medical Sience, Hemmat Expressway
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8670 4743 rezavafa@yahoo.com Iran University of Medical Sciences scientific Mohammadreza Vafa
Nutrition department, School of health, Iran University of Medical Science, Hemmat Expressway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4743 rezavafa@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Having the consent and willingness to participate in the study Age range from 35 to 65 years Passing 6 to 8 weeks after the first heart attack BMI< 30 Kg/m2 35 years 65 years Both Smoking, alcohol consumption or narcotic use Taking vitamin, antioxidant or omega-3 supplements in the last 3 months Taking non-steroidal anti-inflammatory drugs over the past 3 months Suffering or having a history of chronic inflammation, kidney, liver and thyroid disease The occurrence of any problem or sensitivity at any time during the study Non-compliance with treatment (less than 80% or less than 48 days) Changes in physical activity, diet, or change in the type and dosage of the drug during the study and the occurrence of acute illness I21 ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Treatment - Other Treatment - Other Intervention group: 44 men and women with myocardial infarction, each receive a daily dose of 500 milligrams of quercetin supplement after meal for 8 weeks. Control group: 44 men and women with myocardial infarction, each receive a daily dose of 500 milligrams of placebo (containing lactose, cellulose and starch), which looks like to quercetin supplement, after meal for 8 weeks. Tumor necrosis factor alpha (TNF-α). Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: The level of TNF-α in serum is with ELISA method. High-sensitive C-reactive protein (hs-CRP). Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: The level of hs-CRP in serum with Immunoturbidimetry method. Interleukin 6 (IL-6). Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: The level of IL-6 in serum with ELISA method. Total Antioxidant Capacity (TAC). Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: The level of TAC in serum with ELISA method. Quality of life. Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: Myocardial infarction dimensional assessment scale (MIDAS) questionnaire. Systolic blood pressure. Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: sphygmomanometer (mmHg). Diastolic blood pressure. Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: sphygmomanometer (mmHg). Body Mass Index (BMI). Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: body weight in kilograms divided by the square of the body height in meters (kg/m2). Waist circumference. Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: Midpoint between the lower margin of the last palpable rib and the top of the iliac crest. Body fat percentage. Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: Body composition monitor scale. Iran University of Medical Sciences Approved 2018-02-12 Ethics committee of Iran University of Medical Science Hemmat Express way, Iran University of Medical Science Tehran Tehran Iran (Islamic Republic of)