The effect of quercetin supplement on inflammatory factors and quality of life in patients with myocardial infarction

The effect of quercetin supplement on inflammatory factors and quality of life in patients with myocardial infarction

This study is a double-blind randomized clinical trial which will be done in patients with myocardial infarction who referred to the heart department of Rasoul-e-Akram Hospital in 2018-2019. Individuals who are willing to participate and enter the study, sign a written informed consent and enter the study. The duration of the study is 8 weeks, which is randomly assigned to 44 patients with myocardial infarction in quercetin supplement group and 44 patients with myocardial infarction in the placebo group. This study is in the third Phase of clinical trial.

In this study, patients with myocardial infarction referring to Hazrat Rasoul-e-Akram Hospital, who according to inclusion criteria and exclusion criteria, have the criteria to participate the study, would be asked to complete a written informed consent form. Individuals will be randomly assigned to receive intervention or placebo. Then, at the beginning and at the end of the study, 10 cc of fasting blood will be drawn. The level of inflammatory factors IL-6, TNF-α, hs-CRP and serum TAC levels will be measured. At the beginning and the end of the study, anthropometric measurments and personal information questionnaires, myocardial infarction dimensional assessment scale (MIDAS), physical activity, and 24-hour recall are filled through interview.

Inclusion criteria: 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, Body mass index less than 30 kilogram/meter2 Exclusion criteria: smoking, alcohol consumption or narcotic use, taking vitamin, antioxidant or omega-3 supplements in the past 3 months, taking non-steroidal anti-inflammatory drugs in the past 3 months, 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 changes in the type and dosage of the drug during the study, and Acute illness

Quercetin group: 44 men and women with myocardial infarction, each receive a daily dose of 500 mmilligrams of quercetin supplement after meal for 8 weeks. Placebo group: 44 men and women with myocardial infarction, each receive a daily dose of 500 milligrams of placebo tablet (containing lactose, cellulose and starch), which looks like quercetin supplement, after meal for 8 weeks.

The primary outcoms of this study are inflammatory factors (hs-CRP and TNF-α).

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).

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.

Only a part of the data will be shared, such as primary outcomes and Etc.

The access period will be 6 months after the publication of the results.

The obtained data from current study will be available only for researchers working in academic and scientific institutions.

Six months after the publication of this study papers, the obtained data will be available to the applicant researchers for further analysis.

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

Applicants will be able to access the obtained data from current study by sending an email to the corresponding author up to one week.