<?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>IRCT20181224042106N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-16</date_registration>
      <primary_sponsor>Islamic Azad University, Isfahan Branch (Khorasgan), Research Deputy</primary_sponsor>
      <public_title>A review of low-carbohydrate diet and crossfit on women's performance</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of a Low-carbohydrate Diet Combined with CrossFit Training on Ghrelin levels, Insulin and Performance in Active Woman.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40411</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method: Simple randomization;
Randomization Tool: Random Number Table;
 Randomization Unit: Individual;

For using a random number table, the researcher determined the reading position of the table numbers. Then the numbers were considered for different groups. After that, the numbers were recorded and assigned to four groups, including low carbohydrate diet, cross-fit training, combination, and control. Furthermore, to hide random allocation, the method of coded boxes with the random sequence was used. In this method, several boxes that are numbered based on a random sequence were provided.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Female Athletes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1:Low carb diet, low carb diet includes 40% carbohydrates, 40% fat and 20% protein. Intervention 2: Intervention group 2: Cross-fit training, training for 8 weeks and 3 sessions of cross-fit training per week, including weightlifting, gymnastics. Intervention 3: Intervention group 3: Low carb diet, low carb diet including 40% carbohydrates, 40% fat and 20% protein and cross-fit workout, workout for 8 weeks and 3 sessions of cross-fit workouts per week including weightlifting, gymnastics. Intervention 4: Control group: Control group: No intervention, only follow up.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzaneh Taghian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorasgan University, Arghavanie St, Isfahan</address>
        <city>اصفهان</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8183895183</zip>
        <telephone>+98 31335002352</telephone>
        <email>F_taghian@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farzaneh Taghian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorasgan University, Arghavanie St, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8183895183</zip>
        <telephone>+98 31335002352</telephone>
        <email>F_taghian@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have at least 6 months of functional training
Normal BMI
Cardiovascular health
Don't  use hormones , stimulants and fat burners drugs, During the study</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Skeletal, muscular and metabolic problems that limiting exercise activities
Enter the menopausal period
Have blood pressure and diabetes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y93.B9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Activity, other specified sports and athletics</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1:Low carb diet, low carb diet includes 40% carbohydrates, 40% fat and 20% protein</i_keyword>
      <i_keyword>Intervention group 2: Cross-fit training, training for 8 weeks and 3 sessions of cross-fit training per week, including weightlifting, gymnastics</i_keyword>
      <i_keyword>Intervention group 3: Low carb diet, low carb diet including 40% carbohydrates, 40% fat and 20% protein and cross-fit workout, workout for 8 weeks and 3 sessions of cross-fit workouts per week including weightlifting, gymnastics</i_keyword>
      <i_keyword>Control group: Control group: No intervention, only follow up</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum ghrelin concentration. Timepoint: At the beginning and end of the study after 8 weeks. Method of measurement: Serum concentration of ghrelin by ELISA method using the Lake.Inc Monobind USA.C kit in USA.</prim_outcome>
      <prim_outcome>Serum insulin  concentration. Timepoint: At the beginning and end of the study after 8 weeks. Method of measurement: Serum concentration of insulin by ELISA method using the (Sweden, Uppsala, Mercodia) kit.</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>Islamic Azad University, Isfahan Branch (Khorasgan), Research Deputy</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-16</approval_date>
        <contact_name>Ethics Committee on Research Islamic Azad University - Isfahan Branch (Khorasgan)</contact_name>
        <contact_address>University Blvd , Arghavanie , East Gay Street, Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
