<?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>IRCT20231126060196N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-20</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Effect of low glycemic index diet on body composition and fatigue</public_title>
      <acronym></acronym>
      <scientific_title>The effect of low glycemic index diet on body composition and fatigue in amateur strength athletes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>38</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73977</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The people participating in the study were divided into 2 groups of case (receiver of diet with low glycemic index) and control (regular diet) by random block allocation method and using RAS software, and followed the respective diet for 4 weeks. People who must follow a low glycemic index diet are given a list of prohibited foods during this period, Blinding description: The participants in this study were in a separate group; Both groups were given a file, the case group received a diet and the control group continued with their normal diet and only the study process was explained from beginning to end.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Body composition-fatigue factors.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group is fully justified at the beginning of the study process and a consent form is obtained; At first, a blood sample will be taken from them and an analysis and anthropometric measurements will be performed. Finally, the study will be repeated after 28 days. Food record sheets will also be given, which record 3days at the beginning, middle and end of the study. Along with strength training, foods with a high glycemic index, whose list was given to the intervention group, are removed from their diet. Intervention 2: Control group: The control group is fully justified in the beginning of the study process and a consent form is taken; At first, a blood sample will be taken from them and an analysis and anthropometric measurements will be performed. Finally, the study will be repeated after 28 days. Food record sheets will also be given, which record 3days at the beginning, middle and end of the 3-day study.</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>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdi Samavat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Salmani St.- North Nawab St.-Qazvin</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419915315</zip>
        <telephone>+98 28 3333 6001</telephone>
        <email>Mahdisamavat3125@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahdi Samavat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Salmani St.- North Nawab St. - Qazvin</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>34199-15315</zip>
        <telephone>+98 28 3333 6001</telephone>
        <email>Mahdisamavat3125@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>.    Tendency to participate in the study
.    Amateur athletes
.    Age between 20-45 years
.    Having perfect physical health
.    Not using antioxidant supplements in the last month</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Using hormones and steroid drugs
Using sports supplements to increase strength and energy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group is fully justified at the beginning of the study process and a consent form is obtained; At first, a blood sample will be taken from them and an analysis and anthropometric measurements will be performed. Finally, the study will be repeated after 28 days. Food record sheets will also be given, which record 3days at the beginning, middle and end of the study. Along with strength training, foods with a high glycemic index, whose list was given to the intervention group, are removed from their diet.</i_keyword>
      <i_keyword>Control group: The control group is fully justified in the beginning of the study process and a consent form is taken; At first, a blood sample will be taken from them and an analysis and anthropometric measurements will be performed. Finally, the study will be repeated after 28 days. Food record sheets will also be given, which record 3days at the beginning, middle and end of the 3-day study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body Composition. Timepoint: At the beginning of the study and 28 days after the start of the study. Method of measurement: Body َAnalysis device.</prim_outcome>
      <prim_outcome>Fatigue factors: AST, LDH. Timepoint: At the beginning of the study and 28 days after the start of the study. Method of measurement: Blood test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fat mass. Timepoint: ََAt the beginning and 28 days later at the end of the study. Method of measurement: Inbody 270.</sec_outcome>
      <sec_outcome>Fat percentage. Timepoint: At the beginning and 28 days later at the end of the study. Method of measurement: Inbody 270.</sec_outcome>
      <sec_outcome>Skeletal muscle mass. Timepoint: at the beginning and 28 days later at the end of the study. Method of measurement: Inbody 270.</sec_outcome>
      <sec_outcome>Weight. Timepoint: At the beginning and 28 days later at the end of the study. Method of measurement: Scale with an accuracy of 50 grams.</sec_outcome>
      <sec_outcome>BMI. Timepoint: At the beginning and 28 days later at the end of the study. Method of measurement: Ratio of weight to height to exponentiation 2.</sec_outcome>
      <sec_outcome>Abdominal circumference. Timepoint: At the beginning and 28 days later at the end of the study. Method of measurement: Meter.</sec_outcome>
      <sec_outcome>Hips circumference. Timepoint: At the beginning and 28 days later at the end of the study. Method of measurement: Meter.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-12</approval_date>
        <contact_name>Ethics Committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Qazvin University of medical sciences- Shahid Bahonar Boulevard- Qazvin Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
