<?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>IRCT20230112057115N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-09</date_registration>
      <primary_sponsor>Ardabil University of Medical Sciences</primary_sponsor>
      <public_title>The effect of TRF and exercise on health indicators</public_title>
      <acronym>GTES</acronym>
      <scientific_title>The Effect of TRF and Exercise on Inflammatory,Metabolic and Hormonal Indicators in Overweight Men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>9</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68149</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Simple randomization model is used for the study.Subjects are randomly placed in one of the three study groups with the help of a random number table and receive the intervention related to the same group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Overweight.</hc_freetext>
      <i_freetext>Intervention group: The first group: TRF with a 6-hour feeding window (8-14) along with low-intensity aerobic exercise* The second group: TRF  with an 8-hour feeding window (8-16) along with low-intensity aerobic exercise * The third group: TRF with a 10-hour feeding window (8-18) along with low-intensity aerobic exercise. There is no control group and the effect of independent variables of TRF and exercise on the study groups are compared with dependent variables in three occasions before the intervention, 6 weeks from the start of the intervention and 12 weeks from the start of the intervention. A comparison is made between the groups themselves in terms of the amount and intensity of changes in the dependent variables in these three times..</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 Our subjects are not sick, just overweight.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamid Mohebbi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasht, Persian Gulf highway (kilometer 5 of the Rasht-Qazvin road), Gilan University Complex, Faculty of Physical Education and Sports Sciences</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۱۹۹۶۱۳۷۷۶</zip>
        <telephone>۸ -۳۳۶۹۰۲۷۴-۰۱۳</telephone>
        <email>mohebbi_h@yahoo.com</email>
        <affiliation>Gilan University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Mohebbi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasht, Persian Gulf highway (kilometer 5 of the Rasht-Qazvin road), Gilan University Complex, Faculty of Physical Education and Sports Sciences</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۱۹۹۶۱۳۷۷۶</zip>
        <telephone>33690274-013</telephone>
        <email>mohebbi_h@yahoo.com</email>
        <affiliation>Gilan University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being male
Age 35 to 55 years
Body mass index 25 to 30</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>55 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Pulmonary disease
Having diabetes
Suffering from other metabolic diseases
Inflammatory diseases
Suffering from cardiovascular diseases
Having liver diseases</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>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The first group: TRF with a 6-hour feeding window (8-14) along with low-intensity aerobic exercise* The second group: TRF  with an 8-hour feeding window (8-16) along with low-intensity aerobic exercise * The third group: TRF with a 10-hour feeding window (8-18) along with low-intensity aerobic exercise. There is no control group and the effect of independent variables of TRF and exercise on the study groups are compared with dependent variables in three occasions before the intervention, 6 weeks from the start of the intervention and 12 weeks from the start of the intervention. A comparison is made between the groups themselves in terms of the amount and intensity of changes in the dependent variables in these three times.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measurement of height, weight and BMI. Timepoint: Before the intervention, 6 weeks after the start of the intervention, 12 weeks after the intervention. Method of measurement: اندازه گیری توسط وزنه دیجیتال و متر نواری.</prim_outcome>
      <prim_outcome>Vo2max. Timepoint: Before the intervention, 6 weeks after the start of the intervention, 12 weeks after the intervention. Method of measurement: Measuring by tread mill and bulk test.</prim_outcome>
      <prim_outcome>Measurement of body composition. Timepoint: Before the intervention, 6 weeks after the start of the intervention, 12 weeks after the intervention. Method of measurement: Using caliper and 7-point method and "Jackson-Palux" equation for bone density and "Siris" formula to obtain fat percentage.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fasting plasma concentrations of Glucose, insulin, cortisol. Timepoint: Before the intervention, 6 weeks after the start of the intervention, 12 weeks after the intervention. Method of measurement: Using glucose oxidase method to measure glucose concentration and ELISA technique to measure other blood factors in plasma.</sec_outcome>
      <sec_outcome>Measurement of plasma concentration of leptin, AGRP, ghrelin. Timepoint: Before the intervention, 6 weeks after the start of the intervention, 12 weeks after the intervention. Method of measurement: ELISA technique.</sec_outcome>
      <sec_outcome>Measurement of plasma concentration of TNF-α, IL6 CRP. Timepoint: Before the intervention, 6 weeks after the start of the intervention, 12 weeks after the intervention. Method of measurement: ELISA technique.</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>Ardabil University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-28</approval_date>
        <contact_name>Research Ethics Committee of University of Guilan</contact_name>
        <contact_address>Rasht, Persian Gulf Highway, Kilometer 5 Qazvin Road, Gilan University Complex Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
