<?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>IRCT20200804048306N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-13</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The Effect Of 8 Weeks Combined Training (Aerobic-Resistance) At Home With Quinoa Seed Supplementation On Total Antioxidant Capacity And Appetite In Women With Type 2 Diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The Effect Of 8 Weeks Combined Training (Aerobic-Resistance) At Home With Quinoa Seed Supplementation On Total Antioxidant Capacity And Appetite In Women With Type 2 Diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54318</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This research is of quasi-experimental type with pre-test and post-test design. The statistical population of this study is women in the age range of 35 to 65 years and with type 2 diabetes in Kermanshah, who will be selected by clinical trials. According to the corona conditions, the sample size will be estimated at 36 people: then the subjects will be divided into 3 groups using simple random sampling, including: the first group: quinoa supplement (12 people); The second group: quinoa supplementation and resistance-aerobic exercise (12 people); Third group: control (12 people) will be divided. None of the subjects will be aware of the status of supplementation and groupings. The researcher numbers the names of the subjects and puts the numbers in an envelope and another person enters the names and puts them in 3 groups, respectively, Blinding description: This research is of quasi-experimental type with pre-test and post-test design. The statistical population of this study is women in the age range of 35 to 65 years and with type 2 diabetes in Kermanshah, who will be selected by clinical trials. According to the corona conditions, the sample size will be estimated at 36 people: then the subjects will be divided into 3 groups using simple random sampling, including: the first group: quinoa supplement (12 people); The second group: quinoa supplementation and resistance-aerobic exercise (12 people); Third group: control (12 people) will be divided. None of the subjects will be aware of the status of supplementation and groupings. The researcher numbers the names of the subjects and puts the numbers in an envelope and another person enters the names and puts them in 3 groups, respectively.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The exercise plus supplement group and the supplement group will consume 25 grams/day of cooked quinoa seeds  with a snack in the morning and from 10 to 11 o'clock for 8 weeks. Intervention 2: Intervention group: Exercise plus supplement group also performs combined training (aerobic-resistance) 3 days in week for 8 weeks. The combined training program includes: 5-10 minutes warm-up (stretching and kinetic movements), the main body of the combined training includes 30 minutes of resistance training and then 30 minutes of aerobic training, which includes walking at a preferred speed. Resistance exercises will be done 8 to 12 repetitions in 3 sets (the first week 8 repetitions for body adaptation, the second and third weeks 10 repetitions and finally the fourth to eighth weeks 12 repetitions) with 60 second rest intervals between each set. Intervention 3: Control group: The control group also engages in their normal daily activities for 8 weeks.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nillofar moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Karmandan Street, Station 4</address>
        <city>kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715769751</zip>
        <telephone>+98 83 3429 5590</telephone>
        <email>n.moradi@stu.razi.ac.ir</email>
        <affiliation>Razi University of Kermanshah</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nillofar moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Karmandan Street, Station 4</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715769751</zip>
        <telephone>+98 83 3429 5590</telephone>
        <email>n.moradi@stu.razi.ac.ir</email>
        <affiliation>Razi University of Kermanshah</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The present study will be conducted by quasi-experimental research method and pre-test-post-test design, one-sided blind and random selection. In this randomized one-blind design with a 15% probability 36 women with type 2 diabetes (35-65 years) in Kermanshah will be selected as a statistical sample. After obtaining permission from the ethics committee of Razi University of Kermanshah and after being called to the Diabetes Center, participants who have been suffering from diabetes for less than ten years will be called. Inclusion criteria include: less than ten years of type 2 diabetes at the discretion of the treating physician, A1c level between 6.4 to 10, no insulin use, no regular exercise, no pregnancy, no allergy to quinoa seeds, age 35-64 years. All subjects are explained the goals and nature of the research and individuals participate in the research voluntarily. Subjects are assured that the information will remain confidential and that the information will be used solely for the purposes of this study. Subjects can leave the study any time that they want.</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Exclusion criteria include: use of insulin during the study, hospitalization during the study, intolerance to exercise (expression of discomfort, severe lethargy, imbalance and confusion), cardiovascular disease, lack of regular participation Exercises, foot ulcers and complications in the legs during the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10, E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The exercise plus supplement group and the supplement group will consume 25 grams/day of cooked quinoa seeds  with a snack in the morning and from 10 to 11 o'clock for 8 weeks.</i_keyword>
      <i_keyword>Intervention group: Exercise plus supplement group also performs combined training (aerobic-resistance) 3 days in week for 8 weeks. The combined training program includes: 5-10 minutes warm-up (stretching and kinetic movements), the main body of the combined training includes 30 minutes of resistance training and then 30 minutes of aerobic training, which includes walking at a preferred speed. Resistance exercises will be done 8 to 12 repetitions in 3 sets (the first week 8 repetitions for body adaptation, the second and third weeks 10 repetitions and finally the fourth to eighth weeks 12 repetitions) with 60 second rest intervals between each set.</i_keyword>
      <i_keyword>Control group: The control group also engages in their normal daily activities for 8 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Antioxidants are compounds that are able to protect biological systems against the harmful effects of reactive oxygen species and oxygen. In fact, antioxidants play an important role in inhibiting the active species of oxygen and nitrogen and preventing their formation. The involvement of reactive oxygen species, oxygen, nitrogen and chlorine in the pathology of many diseases, including type 2 diabetes, has been well established. Therefore, the effect of quinoa seeds and exercise on total antioxidant capacity and appetite in people with type 2 diabetes is investigated. Timepoint: 2 months. Method of measurement: By blood measurements.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Razi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-13</approval_date>
        <contact_name>National Ethics Committee in Biomedical Research</contact_name>
        <contact_address>Karmandan Street, Station 4 kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
