<?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>IRCT20191204045612N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-31</date_registration>
      <primary_sponsor>University of Isfahan</primary_sponsor>
      <public_title>Comparison of two high protein diets and physical activity on physical performance, biochemical markers and body composition in resistance-trained males</public_title>
      <acronym></acronym>
      <scientific_title>The effects of two resistance and concurrent training programs with high protein diets on physical performance, biochemical markers, and body composition in resistance trained males</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61555</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Other design features: Two resistance training groups will be the control groups for concurrent training groups, Randomization description: In this study, a simple randomization method using random number table is used. This method first uses a random number table, which is a set of numbers that have no pattern or order and which is completely generated. The researcher divides these numbers randomly between the intervention groups (both resistance training groups are the controls of concurrent training groups). With the presence of clients, the researcher begins to read the numbers in the specified order. Each participant receives its own number and is randomly assigned to either resistance training groups (2 groups: resistance training with 1.6 g/kg/day of protein and resistance training with 3.2 g/kg/day of protein ) or concurrent training groups (2 groups: concurrent training +  1.6 g/kg/day of protein and concurrent training +  3.2 g/kg/day of protein ), Blinding description: This study is a double-blind study. Since the researcher and the participants should not be aware of the group and the amount of protein consumed, a third person who is not aware of the objectives of the study will do the group assignment and protein recommendation. Also, the third person will codify them randomly and then provide the researcher with the code. It should be noted that all participants will be informed about the research and objectives, but will not be given information about which group they belong to. Data analysis will also be performed by an out-of-group biostatics specialist who is not aware of the participants and group assignment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Body composition, muscular and cardiovascular adaptation in resistance-trained males.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Resistance training + high protein diet (1.6 g/kg/day). In this group, participants will train for 4 sessions per week for 16 weeks. It should be noted that resistance training in the two groups of resistance training will be the same and there will be only a difference in the dose of protein consumed. Regarding testing sessions for all intervention groups, on the first visit, questionnaires will be assessed; on the second visit, blood draw (after 48 hours of rest and 8 overnight sleep), and body composition will be performed; on the third visit, maximal aerobic capacity (Vo2max) and performance tests will be performed; on the fourth visit, participants will complete chest press and leg press 1RM, muscular endurance tests (75% of 1RM), and muscular power. After completing the pre-test process, the participants will be visited by a nutritionist and will be informed about the nutritional conditions of the study. Intervention 2: Intervention group 2: Resistance training + high protein diet (3.2 g/kg/day). In this group, participants will also train for 4 sessions per week for 16 weeks. It should be noted that resistance training in the two groups of resistance training will be the same and there will be only a difference in the dose of protein consumed. Intervention 3: Intervention group 3: Concurrent training + high protein diet (1.6 g/kg/day). In this group, participants will also train for 4 sessions per week for 16 weeks. It should be noted that resistance training in the two groups of concurrent training will be the same and there will be only a difference in the dose of protein consumed. In this group, participants will perform resistance training at the beginning of the session and then will perform endurance training. Intervention 4: Intervention group 3: Concurrent training + high protein diet (3.2 g/kg/day). In this group, participants will also train for 4 sessions per week for 16 weeks. It should be noted that resistance training in the two groups of concurrent training will be the same and there will be only a difference in the dose of protein consumed. In this group, participants will perform resistance training at the beginning of the session and then will perform endurance training.</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's no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati St, Hatami 7</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9189763902</zip>
        <telephone>+98 51 3521 4034</telephone>
        <email>will.fivb@yahoo.com</email>
        <affiliation>University of Isfahan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati st, Hatami 7</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9189763902</zip>
        <telephone>+98 51 3521 4034</telephone>
        <email>will.fivb@yahoo.com</email>
        <affiliation>University of Isfahan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have a history of resistance training for at least 1 year on a regular basis (at least three training sessions per week).
All the participants will be males.
Having a normal sleep state.
In terms of health status; Healthy and have no specific problems or diseases.
Between the age of 18 to 35 years.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Musculoskeletal injuries
Not following the prescribed diet
Anabolic steroid injection
Contributing in exercises out of prescribed ones
Lack of inner desire to carry on exercise or diet  intervention</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y93.B</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Activities involving other muscle strengthening exercises</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Resistance training + high protein diet (1.6 g/kg/day). In this group, participants will train for 4 sessions per week for 16 weeks. It should be noted that resistance training in the two groups of resistance training will be the same and there will be only a difference in the dose of protein consumed. Regarding testing sessions for all intervention groups, on the first visit, questionnaires will be assessed; on the second visit, blood draw (after 48 hours of rest and 8 overnight sleep), and body composition will be performed; on the third visit, maximal aerobic capacity (Vo2max) and performance tests will be performed; on the fourth visit, participants will complete chest press and leg press 1RM, muscular endurance tests (75% of 1RM), and muscular power. After completing the pre-test process, the participants will be visited by a nutritionist and will be informed about the nutritional conditions of the study.</i_keyword>
      <i_keyword>Intervention group 2: Resistance training + high protein diet (3.2 g/kg/day). In this group, participants will also train for 4 sessions per week for 16 weeks. It should be noted that resistance training in the two groups of resistance training will be the same and there will be only a difference in the dose of protein consumed.</i_keyword>
      <i_keyword>Intervention group 3: Concurrent training + high protein diet (1.6 g/kg/day). In this group, participants will also train for 4 sessions per week for 16 weeks. It should be noted that resistance training in the two groups of concurrent training will be the same and there will be only a difference in the dose of protein consumed. In this group, participants will perform resistance training at the beginning of the session and then will perform endurance training.</i_keyword>
      <i_keyword>Intervention group 3: Concurrent training + high protein diet (3.2 g/kg/day). In this group, participants will also train for 4 sessions per week for 16 weeks. It should be noted that resistance training in the two groups of concurrent training will be the same and there will be only a difference in the dose of protein consumed. In this group, participants will perform resistance training at the beginning of the session and then will perform endurance training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Muscle strength. Timepoint: Pre-test, week 8 and week 17 (after 16 weeks of training). Method of measurement: 1RM tests for chest and leg press.</prim_outcome>
      <prim_outcome>Power. Timepoint: Pre-test, week 8 and week 17 (after 16 weeks of training). Method of measurement: Wingate test for upper and lower body.</prim_outcome>
      <prim_outcome>Biochemical markers for adipose tissue, liver and kidney. Timepoint: Pre-test, week 8 and week 17 (after 16 weeks of training). Method of measurement: Measurements with laboratory kits.</prim_outcome>
      <prim_outcome>Vo2max. Timepoint: Pre-test, week 8 and week 17 (after 16 weeks of training). Method of measurement: Through Bruce test.</prim_outcome>
      <prim_outcome>Muscular endurance. Timepoint: Pre-test, week 8 and week 17 (after 16 weeks of training). Method of measurement: Through 75% of 1RM for chest and leg press.</prim_outcome>
      <prim_outcome>Body composition. Timepoint: Pre-test, week 8 and week 17 (after 16 weeks of training). Method of measurement: Through DXA, 3D scan, and BIA.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The relationship between lean mass and muscular adaptation. Timepoint: At the end of the study. Method of measurement: With statistical analysis methods.</sec_outcome>
      <sec_outcome>Comparison between DXA, BIA, and 3D scan. Timepoint: Pre-test, week 8 and week 17. Method of measurement: Hologic Discovery, Inbody device, and 3d scan.</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>University of Isfahan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-26</approval_date>
        <contact_name>Research ethics committee of university of Isfahan</contact_name>
        <contact_address>Isfahan, Azadi Square, University of Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
