<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/NCT04491188</url>
  </required_header>
  <id_info>
    <org_study_id>01082018</org_study_id>
    <nct_id>NCT04491188</nct_id>
  </id_info>
  <brief_title>Plasma Amino Acid Response to Whey Protein Ingestion Following 28-days of Probiotic Supplementation</brief_title>
  <official_title>Plasma Amino Acid Response to Whey Protein Ingestion Following 28-days of Probiotic (Bacillus Subtilis DE111) Supplementation in Active Men and Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lipscomb University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Deerland Enzymes</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Lipscomb University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Active males and females consumed a probiotic for 28-days. Before and after the intervention&#xD;
      period, participants reported to the lab in a fasted state where they consumed 25 grams of&#xD;
      whey protein. Following drink consumption, participants provided blood draws at 15-minute&#xD;
      intervals. Blood samples were analyzed for amino acid concentrations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2018</start_date>
  <completion_date type="Actual">May 3, 2018</completion_date>
  <primary_completion_date type="Actual">May 3, 2018</primary_completion_date>
  <phase>N/A</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma Amino Acid response</measure>
    <time_frame>28-days</time_frame>
    <description>We measured plasma amino acid concentrations before and after the 28-day intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>28-days</time_frame>
    <description>Body Fat Percentage (%) will be monitored before and after the intervention via Bioelectical Impedance Analysis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Focus of Study is Amino Acid Appearace in Blood</condition>
  <arm_group>
    <arm_group_label>Probiotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 x10-9 CFU Bacillus subtilis DE111 was consumed daily for 28-days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Maltodextrin placebo was consumed for 28-days</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Bacillus subtilis DE111</intervention_name>
    <description>1 x10-9 CFU Bacillus subtilis DE111 probiotic</description>
    <arm_group_label>Probiotic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Maltodextrin placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-34 years old Participants must have at least 1 year of resistance training&#xD;
             experience.&#xD;
&#xD;
          -  Free of any physical limitations, medications, and supplements that may affect&#xD;
             performance, as determined by a health and activity questionnaire.&#xD;
&#xD;
          -  Are free of musculoskeletal injuries&#xD;
&#xD;
          -  Are not taking medications that may interfere with study measurements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Taking any other nutritional supplement or performance enhancing drug.&#xD;
&#xD;
          -  Any chronic illness that causes continuous medical care&#xD;
&#xD;
          -  Taking any other nutritional supplement or performance enhancing drug.&#xD;
&#xD;
          -  Any chronic illness that causes continuous medical care.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>34 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jeremy Townsend</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lipscomb University</investigator_affiliation>
    <investigator_full_name>Jeremy Townsend</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04491188
org study id: 01082018
nct id: NCT04491188
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Active males and females consumed a probiotic for 28-days. Before and after the intervention
      period, participants reported to the lab in a fasted state where they consumed 25 grams of
      whey protein. Following drink consumption, participants provided blood draws at 15-minute
      intervals. Blood samples were analyzed for amino acid concentrations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Plasma Amino Acid response
time frame: 28-days
description: We measured plasma amino acid concentrations before and after the 28-day intervention
measure: Body Composition
time frame: 28-days
description: Body Fat Percentage (%) will be monitored before and after the intervention via Bioelectical Impedance Analysis.
arm group label: Probiotic
arm group type: Experimental
description: 1 x10-9 CFU Bacillus subtilis DE111 was consumed daily for 28-days
arm group label: Placebo
arm group type: Placebo Comparator
description: Maltodextrin placebo was consumed for 28-days
intervention type: Dietary Supplement
intervention name: Bacillus subtilis DE111
description: 1 x10-9 CFU Bacillus subtilis DE111 probiotic
arm group label: Probiotic
intervention type: Dietary Supplement
intervention name: Placebo
description: Maltodextrin placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 34 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Lipscomb University
investigator full name: Jeremy Townsend
investigator title: Assistant Professor
sharing ipd: Undecided