<?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>IRCT20171223038017N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-09</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Yogurt Fortified with beta-Hydroxy beta-Methyl Butyrate (HMB) in Sarcopenic Elderly</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the Effect of Yogurt Fortified with beta-Hydroxy beta-Methyl Butyrate (HMB), Vitamin D, and Vitamin C on Fat-Free Mass, Muscle Strength, and Physical Functionality in Sarcopenic Elderly</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28377</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Individuals will be classified into placebo and target groups with block randomization and Random allocation  methods, Blinding description: All participants in this study are unaware about their grouping because the package, label, and appearance of the target and placebo yogurt are quite similar. Since participants are not referred based on their group to clinical follow-up and outcome evaluator and he/she is also unaware of the separation of individuals. The principle investigators are not directly connected with the participants, so they are not aware of their grouping. An importer of data will also be outside the study system, which is generally unaware of the nature of the study.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Sarcopenia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: receiving 400 grams per day of yogurt fortified with beta-hydroxy beta-butyl butyrate (HMB), vitamin D, and C for 12-week intervention that were produced by Zarrin Ghazal Industrial Co. (Daity). Intervention 2: Control group: receiving 400 grams per day of placebo yogurt for 12-week intervention that were produced by Zarrin Ghazal Industrial Co. (Daity).</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 As we prefer that only colleagues have access to the data, we have not yet decided on this.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohammad Hossein Dabbaghmanesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Office of Vice chancellor for research, Central Building of Shiraz University of Medical Sciences, Zand Street</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134814336</zip>
        <telephone>+98 71 3235 7282</telephone>
        <email>dabbaghm@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Zahra Sohrabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nutrition and Food Science, Fatholmobin alley, Razi blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7153675541</zip>
        <telephone>+98 71 3725 1007</telephone>
        <email>zahra_2043@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Men and women aged 65 years and older
Sarcopenia diagnosis according to European Working Group on Sarcopenia in Older People (EWGSOP) guidelines</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Subjects unable to move without crutches, walker or other assistive devices.
Subjects with artificial limbs.
Subjects with history of chronic disease (e.g. Congestive Heart Failure (CHF), Chronic Obstructive Pulmonary Disorder (COPD), Chronic Renal Failure (CRF), cirrhosis liver failure and active cancer).
Subjects with history of kidney stones.
Subjects who regularly consume  any medications interfering with nutritional intervention (e.g. steroids, heparin, free amino acid, antioxidant, omega-3, vitamin D supplements).</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M62.84</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sarcopenia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: receiving 400 grams per day of yogurt fortified with beta-hydroxy beta-butyl butyrate (HMB), vitamin D, and C for 12-week intervention that were produced by Zarrin Ghazal Industrial Co. (Daity)</i_keyword>
      <i_keyword>Control group: receiving 400 grams per day of placebo yogurt for 12-week intervention that were produced by Zarrin Ghazal Industrial Co. (Daity)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fat-free mass. Timepoint: Before and after intervention. Method of measurement: Dual energy X-ray Absorptiometry (DXA); Bioelectrical Impedance Analysis (BIA).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hand grip. Timepoint: Before and after intervention. Method of measurement: Hydraulic Hand Dynamometer.</sec_outcome>
      <sec_outcome>Physical performance (gait speed). Timepoint: Before and after intervention. Method of measurement: Stopwatch.</sec_outcome>
      <sec_outcome>Physical activity. Timepoint: Before and after intervention. Method of measurement: International Physical Activity Questionnaire (IPAQ).</sec_outcome>
      <sec_outcome>Nutritional status. Timepoint: Before and after intervention. Method of measurement: Mini Nutritional Assessment (MNA) questionnaire.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Before and after intervention. Method of measurement: The Short Form Health Survey-12 (SF-12) questionnaire.</sec_outcome>
      <sec_outcome>25- hydroxy vitamin D (25-OHD) level. Timepoint: Before and after intervention. Method of measurement: Chemiluminescence immunoassay (CLIA) method.</sec_outcome>
      <sec_outcome>Albumin level. Timepoint: Before and after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kit.</sec_outcome>
      <sec_outcome>Creatinine level. Timepoint: Before and after intervention. Method of measurement: Jaffe’s method.</sec_outcome>
      <sec_outcome>C-Reactive Protein (hs-CRP) level. Timepoint: Before and after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kit.</sec_outcome>
      <sec_outcome>Insulin-like Growth Factor – 1 (IGF-1). Timepoint: Before and after intervention. Method of measurement: Chemiluminescence immunoassay (CLIA) method.</sec_outcome>
      <sec_outcome>Fasting Blood Sugar (FBS) level. Timepoint: Before and after intervention. Method of measurement: Auto analyser.</sec_outcome>
      <sec_outcome>Fasting insulin level. Timepoint: Before and after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kit.</sec_outcome>
      <sec_outcome>Malondialdehyde (MDA) level. Timepoint: Before and after intervention. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Blood urea nitrogen level. Timepoint: Before and after intervention. Method of measurement: Chemical Method (Diazine).</sec_outcome>
      <sec_outcome>Lipid profile (LDL, HDL, Triglyceride, total Cholesterol). Timepoint: Before and after intervention. Method of measurement: Chemical Method (Kit).</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Shiraz University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shiraz University of Medical Sciences</source_name>
      <source_name>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-30</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
