<?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>IRCT2017101423002N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-10-31</date_registration>
      <primary_sponsor>Investigator</primary_sponsor>
      <public_title>Effect of resistance training and Epicatechin on Sarcopenia</public_title>
      <acronym></acronym>
      <scientific_title>Improvement of muscle strength and circulatory levels of plasma Follistatin and Myostatin following resistance training and Epicatechin supplementation in sarcopenic older adults</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19739</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Health service research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sarcopenia.</hc_freetext>
      <i_freetext>Intervention 1: Exercise+Placebo group: participants of this group performed 8 weeks resistance training (at 5 to 6 p.m., three sessions per week, each session took approximately 60 minutes, with 60-80% of one repetition maximum). In addition, during this 8-week period this group received one capsule similar to Epicatechin capsules (in terms of color and shape) with 200 ml water daily, at the same time as the supplement group (one hour before doing resistance training, at 4 p.m.). Intervention 2: Placebo group: participants of this group will receive one capsule similar to Epicatechin capsules (in terms of smell and shape) daily with 200 ml water for 8 weeks, at the same time as the supplement group (at 4 p.m.). Intervention 3: Exercise+supplement group: participants of this group performed 8 weeks resistance training (at 5 to 6 p.m., three sessions per week, each session took approximately 60 minutes, with 60-80% of one repetition maximum). In addition, during this 8-week period this group consumed one Epicatechin capsule daily (1 mg/kg/day), with 200 ml water, one hour before doing resistance training (at 4 p.m.). Intervention 4: Supplement group: participants of this group consumed one Epicatechin capsule daily (1mg/kg/day) with 200 ml water, at 4 p.m. for 8 weeks.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Ghardashi Afousi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Physical Education and Sport Sciences, after the intersection of Jalal Al Ahmad, between 15th and 16th Street, North Kargar Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8835 1740</telephone>
        <email>ghardashi.a@ut.ac.ir</email>
        <affiliation>University of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abbasali Gaeini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Physical Education and Sport Sciences, after the intersection of Jalal Al Ahmad, between 15th and 16th Street, North Kargar Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8835 1740</telephone>
        <email>aagaeini@ut.ac.ir</email>
        <affiliation>University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: males between the age of 65-75 years; suffering from class I sarcopenia (AMMI: less than 10.75 kg.m-2); and having no training experiences over the past 12 months before the study. &#13;
Exclusion criteria: having a history of specific diseases (e.g. valvular heart disease (VHD), ischemic heart disease (IHD); chronic lung disease (COLD); hypertrophic cardiomyopathy (HCM); hyperlipoproteinemia (HLP); hypertension (HTN)); unwillingness to participate in the study; smoking; using supplements or drugs over the past month before the study; suffering from psychological diseases (e.g. mental disorder); and suffering from muscle and joint injuries (e.g. slip disk in the back).</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>75 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></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>Placebo</i_code>
      <i_code>Placebo</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Exercise+Placebo group: participants of this group performed 8 weeks resistance training (at 5 to 6 p.m., three sessions per week, each session took approximately 60 minutes, with 60-80% of one repetition maximum). In addition, during this 8-week period this group received one capsule similar to Epicatechin capsules (in terms of color and shape) with 200 ml water daily, at the same time as the supplement group (one hour before doing resistance training, at 4 p.m.).</i_keyword>
      <i_keyword>Placebo group: participants of this group will receive one capsule similar to Epicatechin capsules (in terms of smell and shape) daily with 200 ml water for 8 weeks, at the same time as the supplement group (at 4 p.m.).</i_keyword>
      <i_keyword>Exercise+supplement group: participants of this group performed 8 weeks resistance training (at 5 to 6 p.m., three sessions per week, each session took approximately 60 minutes, with 60-80% of one repetition maximum). In addition, during this 8-week period this group consumed one Epicatechin capsule daily (1 mg/kg/day), with 200 ml water, one hour before doing resistance training (at 4 p.m.).</i_keyword>
      <i_keyword>Supplement group: participants of this group consumed one Epicatechin capsule daily (1mg/kg/day) with 200 ml water, at 4 p.m. for 8 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Follistatin. Timepoint: Before starting the intervention, after eight weeks intervention. Method of measurement: Blood sample, ELISA method with special kit.</prim_outcome>
      <prim_outcome>Myostatin. Timepoint: Before starting the intervention, after eight weeks intervention. Method of measurement: Blood sample, ELISA method with special kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>BMI. Timepoint: Before and after the intervention. Method of measurement: weight(kg) / height to the power of 2 (cm).</sec_outcome>
      <sec_outcome>AMMI. Timepoint: Before and after the intervention. Method of measurement: DXA.</sec_outcome>
      <sec_outcome>Up and go test. Timepoint: Before and after the intervention. Method of measurement: measuring the test time.</sec_outcome>
      <sec_outcome>Physical activities rate. Timepoint: Before and after the intervention. Method of measurement: Via The Physical Activity Scale for the Elderly questionnaire /PASE.</sec_outcome>
      <sec_outcome>Physical health condition. Timepoint: Before and after the intervention. Method of measurement: using PAR-Q questionnaire.</sec_outcome>
      <sec_outcome>Maximal Strength. Timepoint: Before and after the intervention. Method of measurement: 1RM test.</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>Investigator</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-16</approval_date>
        <contact_name>University of Tehran</contact_name>
        <contact_address>16th Azar Street, Enghelab Square, Central Organization of University of Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
