<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20171130037689N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-03</date_registration>
      <primary_sponsor>University of Tabriz - Research Deputy</primary_sponsor>
      <public_title>Effect of flaxseed supplementation and concurrent training on overweight</public_title>
      <acronym></acronym>
      <scientific_title>Effect of four weeks flaxseed supplementation and concurrent training on  certain factors of cardiovascular disease and cortisol hormones in overweight women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27956</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Prevention, Randomization description: At first, the university will be called upon to invite all women who are overweight to participate in the current study, and then from among the volunteers willing to participate in the study, 36 eligible people will study The age range of 20 to 29 years will be selected. In order to homogenize the subjects, age, height, weight, fat percentage and some blood parameters of all subjects will be measured. Finally, considering these indices and using the Shapiro - Wilk test and ensuring the homogeneity of the data, 36 people will be randomly assigned to four homogeneous groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Overweight.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: flaxseed supplement (62.0 g / kg of body weight per day) in flaxseed supplementary group. Your flaxseed used in this study is from the Green Healing Faculty in Tabriz And was then ground and delivered as powder or broken and participated in a digital scale (0.62 grams per kilogram of body weight per day) in a pack containing three parts. Samples were asked to dissolve each package an hour before food, in three meals, and within 250 milligrams of water. Intervention 2: Intervention group 2: concurrent training (endurance-resistance) in the training group. concurrent training included aerobic exercises with an intensity of 65% of heart rate and resistance training with intensity of 60% 1RM. Intervention 3: Intervention group 3: concurrent training (endurance-resistance) and supplementation of flaxseed (62.0 g / kg of body weight per day) in the training group + flaxseed supplement. Intervention 4: Control group: They did not receive any intervention.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme HalalKhor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>29 Bahman Blvd.,Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166616471</zip>
        <telephone>+98 41 4224 1099</telephone>
        <email>m_nikkhesal@tabrizu.ac.ir</email>
        <affiliation>University of Tabriz</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vahid Sari-Sarraf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>29 Bahman Blvd.,Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5414646871</zip>
        <telephone>+98 41 3339 3251</telephone>
        <email>sarraf@tabrizu.ac.ir</email>
        <affiliation>The University of Tabriz</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>women Students University of Tabriz
Inactivity
overweight
BMI Between 25 and 29/9</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>29 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Smoking
Cardiovascular disease and surgery
Chronic Diseases
Consumption any kind of supplement fat burner
Regularly have exercise activities</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: flaxseed supplement (62.0 g / kg of body weight per day) in flaxseed supplementary group. Your flaxseed used in this study is from the Green Healing Faculty in Tabriz And was then ground and delivered as powder or broken and participated in a digital scale (0.62 grams per kilogram of body weight per day) in a pack containing three parts. Samples were asked to dissolve each package an hour before food, in three meals, and within 250 milligrams of water.</i_keyword>
      <i_keyword>Intervention group 2: concurrent training (endurance-resistance) in the training group. concurrent training included aerobic exercises with an intensity of 65% of heart rate and resistance training with intensity of 60% 1RM</i_keyword>
      <i_keyword>Intervention group 3: concurrent training (endurance-resistance) and supplementation of flaxseed (62.0 g / kg of body weight per day) in the training group + flaxseed supplement</i_keyword>
      <i_keyword>Control group: They did not receive any intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight. Timepoint: Before and after the exercise period. Method of measurement: Digital Weight Meter.</prim_outcome>
      <prim_outcome>Body fat percentage. Timepoint: Before and after the exercise period. Method of measurement: Measuring subcutaneous fat with caliper.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cholesterol. Timepoint: Before and after the exercise period. Method of measurement: Colorimetric method using commercial kits.</sec_outcome>
      <sec_outcome>High-density lipoprotein. Timepoint: Before and after the exercise period. Method of measurement: Colorimetric method using commercial kits.</sec_outcome>
      <sec_outcome>Low density lipoprotein. Timepoint: Before and after the exercise period. Method of measurement: Colorimetric method using commercial kits.</sec_outcome>
      <sec_outcome>Serum cortisol level. Timepoint: Before and after the exercise period. Method of measurement: It will be measured using the radioimmunoassay method.</sec_outcome>
      <sec_outcome>Malondialdehyde (MDA). Timepoint: Before and after the exercise period. Method of measurement: Colorimetric method using Germany kit (BioCore).</sec_outcome>
      <sec_outcome>Total antioxidant capacity of the blood. Timepoint: Before and after the exercise period. Method of measurement: Spectrophotometry and ELISA.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>University of Tabriz - Research Deputy</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-19</approval_date>
        <contact_name>Ethics Committee of Sport Sciences Research Institute of Iran</contact_name>
        <contact_address>No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
