<?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>IRCT20180503039517N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-14</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effects of beta-hydroxy beta-methyl butyrate HMB supplementation with selected resistance training on Liver, Muscular, Kidney Enzymes, Lipid Profile, Body Combination, Strength and Some Other Physical Fitness Factors in Bodybuilding Athletes</public_title>
      <acronym></acronym>
      <scientific_title>The effects of beta-hydroxy beta-methyl butyrate HMB supplementation with selected resistance training on some biochemical factors of blood and strength in bodybuilding athletes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>63</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49189</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Other, Randomization description: 40 bodybuilders were selected by available sampling method.
Through drawing (The participants' names were written on paper and selected through a simple random draw for the two intervention groups and a control group), Blinding description: In this research, participants are unaware of the group assigned to themselves and other participants. A separate workout hour is considered for each intervention group.
The person in charge of collecting data and the processor are also unaware of the type of intervention and the people involved in the research groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>supplementation in body builders.</hc_freetext>
      <i_freetext>Intervention 1: The experimental group performed selected resistance exercises for 8 weeks and 3 sessions per week and received HMB supplement in the amount of 3 g per day as two suckers for 14 days. Blood samples are taken from all samples in the laboratory before and after exercise (48 hours apart) and some biochemical factors such as liver, muscle, kidney, and lipid profiles are analyzed in the serum of the subjects. Placed. Intervention 2: Control group: The selected resistance exercises were performed for 8 weeks and 3 sessions per week and the polydextrose capsule was taken in the amount of 3 g per day as two suckers for 14 days. Blood samples are taken from all samples in the laboratory before and after exercise (48 hours apart) and some biochemical factors such as liver, muscle, kidney, and lipid profiles are analyzed in the serum of the subjects.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soleyman Ansari Kolachahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>second floor,  Adibsaber Apartment, next to Esparo restaurant, Prof. Samei Blv.</address>
        <city>RASHT</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4193193933</zip>
        <telephone>+98 911 230 6198</telephone>
        <email>solomonansari@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soleyman Ansari Kolachahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>second floor, Adibsaber Apartment, next to Esparo restaurant, Prof. Samei Blv.</address>
        <city>RASHT</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4193193933</zip>
        <telephone>+98 911 230 6198</telephone>
        <email>solomonansari@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age (19-29years)
Gender (male)
a maximum of 3 months involving in resistance exercise</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>29 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>smoking
having cardiorespiratory, musculoskeletal, neurological, hormonal or orthopedic disorders
No ingestion of androgenic and energetic supplements in the past 1 months</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>Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The experimental group performed selected resistance exercises for 8 weeks and 3 sessions per week and received HMB supplement in the amount of 3 g per day as two suckers for 14 days. Blood samples are taken from all samples in the laboratory before and after exercise (48 hours apart) and some biochemical factors such as liver, muscle, kidney, and lipid profiles are analyzed in the serum of the subjects. Placed.</i_keyword>
      <i_keyword>Control group: The selected resistance exercises were performed for 8 weeks and 3 sessions per week and the polydextrose capsule was taken in the amount of 3 g per day as two suckers for 14 days. Blood samples are taken from all samples in the laboratory before and after exercise (48 hours apart) and some biochemical factors such as liver, muscle, kidney, and lipid profiles are analyzed in the serum of the subjects.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum levels of liver enzymes (Aspartate transaminase (AST) and Alanine transaminase (ALT). Timepoint: Initial blood sampling will be performed in the pre-test phase two days before the start of the study, and final blood sampling will be performed in the post-test phase two days after the end of the study in the laboratory. Method of measurement: Using the Pars Azmoun laboratory kit (made in Iran) according to the manufacturer's instructions and the ELISA method.</prim_outcome>
      <prim_outcome>Serum levels of muscle enzymes (Creatine kinase (CK) and lactate dehydrogenase (LDH)). Timepoint: Initial blood sampling will be performed in the pre-test phase two days before the start of the study, and final blood sampling will be performed in the post-test phase two days after the end of the study in the laboratory. Method of measurement: Using Pars Azmoun laboratory kit (made in Iran) according to the manufacturer's instructions and the ELISA method.</prim_outcome>
      <prim_outcome>Serum levels of renal function enzymes (the blood urea nitrogen (BUN), Creatinine and Urea. Timepoint: Initial blood sampling will be performed in the pre-test phase two days before the start of the study, and final blood sampling will be performed in the post-test phase two days after the end of the study in the laboratory. Method of measurement: Using the Pars Azmoun laboratory kit (made in Iran) according to the manufacturer's instructions and the ELISA method.</prim_outcome>
      <prim_outcome>Serum levels of Lipid profile (low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, Total cholesterol and triglycerides. Timepoint: Initial blood sampling will be performed in the pre-test phase two days before the start of the study, and final blood sampling will be performed in the post-test phase two days after the end of the study in the laboratory. Method of measurement: Using Biosystems Laboratory kit (made in Spain), according to the manufacturer's instructions and the ELISA method.</prim_outcome>
      <prim_outcome>Some physical fitness factors (strength, body composition and power). Timepoint: Initial measurements in the pre-test phase will be performed two days before the start of the study, and final measurement in the post-test phase will be performed two days after the end of the study at the club. Method of measurement: One maximum repetition test and body mass index (BMI) will be used to measure strength and body composition.</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 of Rasht Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-29</approval_date>
        <contact_name>The ethics committee of Islamic Azad University, Rasht Branch</contact_name>
        <contact_address>Islamic Azad University, Rasht Branch, Lakan Blv RASHT Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
