xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06007430</url>
    </required_header>
    <id_info>
      <org_study_id>4-3672 in 27/10/2024</org_study_id>
      <nct_id>NCT06007430</nct_id>
    </id_info>
    <brief_title>Colostrum Supplements Effect on the Physical Performance and Cognitive Function</brief_title>
    <official_title>The Value of Using Colostrum Supplements on the Physical Performance and Cognitive Function in Healthy Subjects and Type 2 Diabetes: A Case-management Comparative Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Al-Mustafa University College</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Al-Mustafa University College</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this interventional Randomized clinical is to compare the effect of colostrum&#xD;
        pharmaceutical preparation and placebo in a sample of Iraqi participants. The main questions&#xD;
        to answer are:&#xD;
  &#xD;
          1. What are the effects of the tested regimens on the level of IL-1 and IL-15.&#xD;
  &#xD;
          2. What are the effects of the tested regimens on the Fasting Blood glucose?&#xD;
  &#xD;
          3. What are the effects of the tested regimens on the HbA1C?&#xD;
  &#xD;
          4. What are the effects of the tested regimens on the Body Mass Index?&#xD;
  &#xD;
          5. What are the effects of the tested regimens on the Lipid profile?&#xD;
  &#xD;
          6. What are the effects of the tested regimens on C-reactive protein?&#xD;
  &#xD;
          7. What are the effects of the tested regimens on Hematological indices?&#xD;
  &#xD;
          8. What are the effects of the tested regimens on Rate pressure product?&#xD;
  &#xD;
        Participants will be separated into four groups:&#xD;
  &#xD;
          1. Group 1 (Healthy control): 24 Patients, will be receiving Placebo Capsule per oral once&#xD;
             daily for 60 days&#xD;
  &#xD;
          2. Group 2 (Healthy control) : 26 Patients, will be receiving Colostrum Capsule 500 mg per&#xD;
             oral once daily for 60 days.&#xD;
  &#xD;
          3. Group 3 (Diabetes Type 2): 23 Patieints, will be receiving Placebo Capsule per oral once&#xD;
             daily for 60 days.&#xD;
  &#xD;
          4. Group 4 (Diabetes Type 2) : 27 Patients, will be receiving Colostrum Capsule 500 mg per&#xD;
             oral once daily for 60 days.&#xD;
  &#xD;
        Researchers will compare Groups 1,2,3, and 4 to observe the effect of the tested treatment&#xD;
        regimens on IL-1, IL-6 ,Fasting Blood Glucose, HbA1c, Body Mass Index, Lipid profile, Rate&#xD;
        pressure product, C-reactive protein, and Hematological indices. and use these measures In&#xD;
        special formulas to determine the effect of the tested regimens on physical performance and&#xD;
        cognitive function.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 15, 2023</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Serum interleukin-1 (IL-1) Level</measure>
      <time_frame>At Baseline, and After 60 days of treatment.</time_frame>
      <description>Measured in Pg/mL</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum interleukin-15 (IL-15) Level</measure>
      <time_frame>At Baseline, and After 60 days of treatment.</time_frame>
      <description>Measured in Pg/mL</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fasting Blood Sugar (FBS)</measure>
      <time_frame>At Baseline, and After 60 days of treatment.</time_frame>
      <description>Measured in mg/dL</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hemoglobin A1C (HbA1C)</measure>
      <time_frame>At Baseline, and After 60 days of treatment.</time_frame>
      <description>Measured in percent from total Hemoglobin</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body Mass Index (BMI)</measure>
      <time_frame>At baseline, and after 60 days of treatment</time_frame>
      <description>Measured in Kg/m²</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Serum C-reactive protein (CRP)</measure>
      <time_frame>At baseline, and after 60 days of treatment</time_frame>
      <description>Measured in mg/dL</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate Pressure Product</measure>
      <time_frame>At baseline, and after 60 days of treatment.</time_frame>
      <description>Measured in an equation combining Heart rate in (BPM) and blood pressure in (mmHg)</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Diabetes Mellitus, Type 2</condition>
    <arm_group>
      <arm_group_label>Group 1 (Healthy Control)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>24 Patients receiving Placebo Capsule per oral once daily for 60 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2 (Healthy control)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>26 Patients receiving Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA), one capsule per oral once daily for 60 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 3 (Diabetes Type 2)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>23 Patients receiving Placebo Capsule per oral once daily for 60 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 4 (Diabetes Type 2)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>27 Patients Receiving Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA), one capsule per oral once daily for 60 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA)</intervention_name>
      <description>Brand name: (Colostrum® 500 mg Veg Capsules) capsules per oral / once daily / 60 days duration.</description>
      <arm_group_label>Group 2 (Healthy control)</arm_group_label>
      <arm_group_label>Group 4 (Diabetes Type 2)</arm_group_label>
      <other_name>Colostrum®</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo Capsule / Capsules per oral / once daily / 60 days duration</description>
      <arm_group_label>Group 1 (Healthy Control)</arm_group_label>
      <arm_group_label>Group 3 (Diabetes Type 2)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Apparently Healthy patients for control&#xD;
  &#xD;
            -  Patients diagnosed with T2DM&#xD;
  &#xD;
            -  Age between 18-70&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with T1DM&#xD;
  &#xD;
            -  Patients with a drug history of anabolic substances for more than 14 days duration.&#xD;
  &#xD;
            -  Patients with co-morbidities (e.g. CVS, renal, hepatic, and endocrine disorders)&#xD;
  &#xD;
            -  Pregnancy, lactation, or female patient willing for conception.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ahmed Khalid Mohammed Albasri, MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Al-Farabi Kazakh National University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Hayder Adnan Fawzi, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Al-Mustafa University College</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ahmed Khalid Mohammed Albasri, MSc</last_name>
      <phone>+9647812831612</phone>
      <email>ahmedalbasri28@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Al-Zahraa Teaching Hospital</name>
        <address>
          <city>Wasit</city>
          <zip>52001</zip>
          <country>Iraq</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hayder Fadhil Lateef, PhD</last_name>
        <phone>+9647809412243</phone>
        <email>Hf_nice@yahoo.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Iraq</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Al-Mustafa University College</investigator_affiliation>
      <investigator_full_name>Hayder Adnan Fawzi</investigator_full_name>
      <investigator_title>Assistant Prof.</investigator_title>
    </responsible_party>
    <keyword>Colostrum</keyword>
    <keyword>Diabetes Mellitus, Type 2</keyword>
    <keyword>Cognition</keyword>
    <keyword>Physical Functional Performance</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06007430
  org study id: 4-3672 in 27/10/2024
  nct id: NCT06007430
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this interventional Randomized clinical is to compare the effect of colostrum
        pharmaceutical preparation and placebo in a sample of Iraqi participants. The main questions
        to answer are:
  
          1. What are the effects of the tested regimens on the level of IL-1 and IL-15.
  
          2. What are the effects of the tested regimens on the Fasting Blood glucose?
  
          3. What are the effects of the tested regimens on the HbA1C?
  
          4. What are the effects of the tested regimens on the Body Mass Index?
  
          5. What are the effects of the tested regimens on the Lipid profile?
  
          6. What are the effects of the tested regimens on C-reactive protein?
  
          7. What are the effects of the tested regimens on Hematological indices?
  
          8. What are the effects of the tested regimens on Rate pressure product?
  
        Participants will be separated into four groups:
  
          1. Group 1 (Healthy control): 24 Patients, will be receiving Placebo Capsule per oral once
             daily for 60 days
  
          2. Group 2 (Healthy control) : 26 Patients, will be receiving Colostrum Capsule 500 mg per
             oral once daily for 60 days.
  
          3. Group 3 (Diabetes Type 2): 23 Patieints, will be receiving Placebo Capsule per oral once
             daily for 60 days.
  
          4. Group 4 (Diabetes Type 2) : 27 Patients, will be receiving Colostrum Capsule 500 mg per
             oral once daily for 60 days.
  
        Researchers will compare Groups 1,2,3, and 4 to observe the effect of the tested treatment
        regimens on IL-1, IL-6 ,Fasting Blood Glucose, HbA1c, Body Mass Index, Lipid profile, Rate
        pressure product, C-reactive protein, and Hematological indices. and use these measures In
        special formulas to determine the effect of the tested regimens on physical performance and
        cognitive function.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Serum interleukin-1 (IL-1) Level
  time frame: At Baseline, and After 60 days of treatment.
  description: Measured in Pg/mL
  measure: Serum interleukin-15 (IL-15) Level
  time frame: At Baseline, and After 60 days of treatment.
  description: Measured in Pg/mL
  measure: Fasting Blood Sugar (FBS)
  time frame: At Baseline, and After 60 days of treatment.
  description: Measured in mg/dL
  measure: Hemoglobin A1C (HbA1C)
  time frame: At Baseline, and After 60 days of treatment.
  description: Measured in percent from total Hemoglobin
  measure: Body Mass Index (BMI)
  time frame: At baseline, and after 60 days of treatment
  description: Measured in Kg/m²
  measure: Serum C-reactive protein (CRP)
  time frame: At baseline, and after 60 days of treatment
  description: Measured in mg/dL
  measure: Rate Pressure Product
  time frame: At baseline, and after 60 days of treatment.
  description: Measured in an equation combining Heart rate in (BPM) and blood pressure in (mmHg)
  arm group label: Group 1 (Healthy Control)
  arm group type: Placebo Comparator
  description: 24 Patients receiving Placebo Capsule per oral once daily for 60 days.
  arm group label: Group 2 (Healthy control)
  arm group type: Active Comparator
  description: 26 Patients receiving Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA), one capsule per oral once daily for 60 days.
  arm group label: Group 3 (Diabetes Type 2)
  arm group type: Placebo Comparator
  description: 23 Patients receiving Placebo Capsule per oral once daily for 60 days.
  arm group label: Group 4 (Diabetes Type 2)
  arm group type: Active Comparator
  description: 27 Patients Receiving Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA), one capsule per oral once daily for 60 days.
  intervention type: Drug
  intervention name: Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA)
  description: Brand name: (Colostrum® 500 mg Veg Capsules) capsules per oral / once daily / 60 days duration.
  arm group label: Group 2 (Healthy control)
  arm group label: Group 4 (Diabetes Type 2)
  other name: Colostrum®
  intervention type: Other
  intervention name: Placebo
  description: Placebo Capsule / Capsules per oral / once daily / 60 days duration
  arm group label: Group 1 (Healthy Control)
  arm group label: Group 3 (Diabetes Type 2)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ahmed Khalid Mohammed Albasri, MSc
  role: Principal Investigator
  affiliation: Al-Farabi Kazakh National University
  last name: Hayder Adnan Fawzi, PhD
  role: Study Chair
  affiliation: Al-Mustafa University College
  last name: Ahmed Khalid Mohammed Albasri, MSc
  phone: +9647812831612
  email: ahmedalbasri28@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Iraq
  responsible party type: Principal Investigator
  investigator affiliation: Al-Mustafa University College
  investigator full name: Hayder Adnan Fawzi
  investigator title: Assistant Prof.
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2