<?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>IRCT2013051313308N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-06-17</date_registration>
      <primary_sponsor>Shahid Sadoughi University of Medical Science,International branch</primary_sponsor>
      <public_title>Flaxseed and prediabetes</public_title>
      <acronym></acronym>
      <scientific_title>Effect of flaxseed on insulin resistance and oxidative stress  in prediabetic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13200</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>prediabetes.</hc_freetext>
      <i_freetext>Intervention 1: In first intrvention group,prediabetic individuals,aged 30-65 years, will recieve a daily allotment of 20 gr ground flaxseed for 12 week.they will be instructed to incorporate the suplement  in their daily meals using method described in instruction pamphlet.They are instructed to substitute flaxseed for some of their usual carbohydrate and fat consumed at the meal.The subjects are told not to change diet and activity level. Intervention 2: In second  intrvention group, prediabetic individuals,aged 30-65 years, will recieve a daily allotment of 40 gr ground flaxseed for 12 week.they will be instructed to incorporate the suplement  in their daily meals using method described in instruction pamphlet.They are instructed to substitute flaxseed for some of their usual carbohydrate and fat consumed at the meal.The subjects are told not to change diet and activity level. Intervention 3: In control group,prediabetic individuals,aged 30-65 years, will recieve no intervention.The subjects are told not to change diet and activity level.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Afrooz Javidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>International campus of Shahid Sadoughi University of Medical Science,  5th kilometer of Fahraj-Khavidak road, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8944157963</zip>
        <telephone>+98 35 1836 7668</telephone>
        <email>afrooz.javidi@gmail.com</email>
        <affiliation>Shahid Sadoughi University of Medical Science-Intrnational branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hasan Mozaffari Khosravi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Health School, Daneshjoo Blvd,Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>89156-887</zip>
        <telephone>+98 35 1624 5900</telephone>
        <email>mozaffari.kh@gmail.com</email>
        <affiliation>Shahid Sadoughi University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:willing to follow study protocol, scheduling, and testing location&#13;
;men and women  30 to 65 years; Body mass index (BMI) of 25 - 34.9 Kg / m2&#13;
;prediabetic patients with fasting blood sugar of 100 -125mg/ dl or a two-hour blood sugar between 140 to 199 mg/ dl;not using Insulin ang other glucose lowering medicatins;non smoking status; not using herbal , antioxidant supplementation and omega-3 until 3 months before intervention;without any history of gastrointestinal and kindney disorder;without any acute  thyroid, kidney, liver, CVD diseases&#13;
&#13;
Exclusion criteria:unwillingness to follow study protocol, scheduling, and testing location;diagnosis of type 2 diabetes;smoking at least 2 tmes a week;regular history of flaxseed or flaxseed oil supplement or any omega-3 supplement intake&#13;
;taking glucose lowering drugs or insulin or estrogen or progesterone drugs&#13;
;pregnancy and lactation</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R73.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Impaired glucose tolerance prediabetes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In first intrvention group,prediabetic individuals,aged 30-65 years, will recieve a daily allotment of 20 gr ground flaxseed for 12 week.they will be instructed to incorporate the suplement  in their daily meals using method described in instruction pamphlet.They are instructed to substitute flaxseed for some of their usual carbohydrate and fat consumed at the meal.The subjects are told not to change diet and activity level.</i_keyword>
      <i_keyword>In second  intrvention group, prediabetic individuals,aged 30-65 years, will recieve a daily allotment of 40 gr ground flaxseed for 12 week.they will be instructed to incorporate the suplement  in their daily meals using method described in instruction pamphlet.They are instructed to substitute flaxseed for some of their usual carbohydrate and fat consumed at the meal.The subjects are told not to change diet and activity level</i_keyword>
      <i_keyword>In control group,prediabetic individuals,aged 30-65 years, will recieve no intervention.The subjects are told not to change diet and activity level.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum concentration of MDA. Timepoint: before and 3 months after intervention. Method of measurement: with spectrophotometer.</prim_outcome>
      <prim_outcome>Serum total  antioxidant capacity. Timepoint: before and 3 months after intervention. Method of measurement: cation decolorization assey ABTS.</prim_outcome>
      <prim_outcome>Insulin resistance. Timepoint: before and 3 months after intervention. Method of measurement: HOMA-IR index.</prim_outcome>
      <prim_outcome>Beta-cell function. Timepoint: before and 3 months after intervention. Method of measurement: ELISA kit.</prim_outcome>
      <prim_outcome>Insulin sensitivity. Timepoint: before and 3 months after intervention. Method of measurement: QUICKI index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: before and after intervention. Method of measurement: scale with accuracy 100 gr.</sec_outcome>
      <sec_outcome>Height. Timepoint: before and after intervention. Method of measurement: tape meter instaled on the wall.</sec_outcome>
      <sec_outcome>BMI(Body Mass Index). Timepoint: before and after intervention. Method of measurement: Calculation:Weight (kg) / squared height (m).</sec_outcome>
      <sec_outcome>Total energy intake. Timepoint: before and after intervention. Method of measurement: 24 hour recall.</sec_outcome>
      <sec_outcome>Charbohydate intake. Timepoint: before and after intervention. Method of measurement: 24 hour recall.</sec_outcome>
      <sec_outcome>Protein intake. Timepoint: before and after intervention. Method of measurement: 24 hour recall.</sec_outcome>
      <sec_outcome>Fat intake. Timepoint: before and after intervention. Method of measurement: 24 hour recall.</sec_outcome>
      <sec_outcome>Fiber intake. Timepoint: before and after intervention. Method of measurement: 24 hour recall.</sec_outcome>
      <sec_outcome>Saturated fatty acid intake. Timepoint: before and after intervention. Method of measurement: 24 hour recall.</sec_outcome>
      <sec_outcome>Mono unsaturated fatty acid intake(MUFA). Timepoint: before and after intervention. Method of measurement: 24 hour recall.</sec_outcome>
      <sec_outcome>Poly unsaturated fatty acid intake(PUFA). Timepoint: before and after intervention. Method of measurement: 24 hour recall.</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>Shahid Sadoughi University of Medical Science,International branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-05-19</approval_date>
        <contact_name>Shahid Sadoughi University of Medical Science</contact_name>
        <contact_address>International campus of Shahid Sadoughi University of Medical Science,  5th kilometer of Fahraj-Khavidak road, Yazd Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
