<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/NCT04427020</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-20-15</org_study_id>
    <nct_id>NCT04427020</nct_id>
  </id_info>
  <brief_title>Changes in Amino Acid Absorption After Adding a Probiotic to an Acute Protein Feeding</brief_title>
  <official_title>Changes in Amino Acid Absorption After Adding a Probiotic to an Acute Protein Feeding</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lindenwood University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lindenwood University</source>
  <oversight_info>
    <has_dmc>No</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 purpose of this study is to examine the pharmacokinetic pattern of amino acid absorption&#xD;
      after a two-week pattern of milk protein supplementation with and without the addition of&#xD;
      Bacillus coagulans GBI-30, 6086.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted using a randomized, double-blind, crossover study design. 30&#xD;
      healthy men and women between the ages of 18 - 55 years of age will be recruited to&#xD;
      participate in this study. Prior to beginning the study, all participants will sign an&#xD;
      IRB-approved informed consent document and complete a healthy history questionnaire to&#xD;
      determine study eligibility. Two supplementation protocols that each span two weeks will be&#xD;
      completed and separated with a washout period of three weeks. For each study visit, all&#xD;
      participants will report to the laboratory between 0600 - 1000 hours after observing an 8 -&#xD;
      10-hour fast. For two weeks prior to each study visit, participants will be assigned in a&#xD;
      randomized, double-blind, crossover fashion to ingest a single daily 25-gram dose of a milk&#xD;
      protein concentrate or a similar dose of milk protein concentrate plus bacillus coagulans&#xD;
      GBI-30, 6086. Upon arrival for each study visit, participants will have their resting heart&#xD;
      rate, blood pressure, body mass, height, and body composition measured using bioelectrical&#xD;
      impedance analysis (BIA). Upon ingestion of their final assigned supplementation dose,&#xD;
      standard multiple sample phlebotomy approaches will used to collect approximately 10mL of&#xD;
      venous blood from a forearm vein before (0 min), 30, 60, 90, 120, 180, and 240 minutes after&#xD;
      ingestion of their final assigned supplementation dose for that period in the study protocol.&#xD;
      Participants will be provided 200 mL of cold water to ingest after each blood collection.&#xD;
      Upon processing, all blood samples will be stored at -80 C. All samples will o be discarded&#xD;
      according to Institutional Review Board-stipulated guidelines. Study participants will be&#xD;
      provided an additional two-week supply of the alternative treatment to begin after observing&#xD;
      a three-week washout. After two weeks of supplementation, study participants will return to&#xD;
      the laboratory for their remaining testing visit. All subsequent study visits will be&#xD;
      completed in a randomized fashion to minimize any order effects from testing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2019</start_date>
  <completion_date type="Actual">December 3, 2019</completion_date>
  <primary_completion_date type="Actual">December 3, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Protein and probiotics were delivered separately. Upon arrival a faculty member (who was not an investigator) blinded both the protein and probiotic samples and kept the code sealed in an envelope until all statistical analysis was complete. Once all data collection, data entry, and statistical analysis was completely finished, the study code was broken.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of amino acid absorption</measure>
    <time_frame>seven weeks</time_frame>
    <description>We intend to determine if the addition of a probiotic to milk protein ingestion changes the rate (in minutes) to which amino acids are absorbed into our bloodstream.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of amino acid absorption</measure>
    <time_frame>seven weeks</time_frame>
    <description>We intend to determine if the addition of a probiotic to milk protein ingestion changes the extent (concentration in millimoles/Liter) to which amino acids are absorbed into our bloodstream.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Amino Acid Absorption</condition>
  <arm_group>
    <arm_group_label>Milk Protein + Probiotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 gram dose of milk protein concentrate with bacillus coagulans GBI-30, 6086</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Milk Protein</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>25 gram dose of milk protein concentrate</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Milk protein + GBI-30</intervention_name>
    <description>Both conditions matched flavor, color, and serving size</description>
    <arm_group_label>Milk Protein + Probiotic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Milk protein</intervention_name>
    <description>Both conditions matched flavor, color, and serving size</description>
    <arm_group_label>Milk Protein</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All participants will be between the ages of 18-55 years.&#xD;
&#xD;
          -  Participants will be healthy and free of disease as determined by evaluation of a&#xD;
             medical history.&#xD;
&#xD;
          -  Completing at least 30 minutes of moderate exercise three days per week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those individuals less than 18 and greater than 55 years of age will be excluded.&#xD;
&#xD;
          -  Any individual who is currently being treated for or diagnosed with a cardiac disorder&#xD;
             or disease&#xD;
&#xD;
          -  Any individual who is currently being treated for or diagnosed with a respiratory&#xD;
             disorder or disease&#xD;
&#xD;
          -  Any individual who is currently being treated for or diagnosed with a circulatory&#xD;
             disorder or disease&#xD;
&#xD;
          -  Any individual who is currently being treated for or diagnosed with a musculoskeletal&#xD;
             disorder or disease&#xD;
&#xD;
          -  Any individual who is currently being treated for or diagnosed with a metabolic&#xD;
             disorder or disease&#xD;
&#xD;
          -  Any individual who is currently being treated for or diagnosed with obesity (defined&#xD;
             as body mass index &gt; 30 kg/m and body fat greater than 30%)&#xD;
&#xD;
          -  Any individual who is currently being treated for or diagnosed with an immune or&#xD;
             autoimmune disorder or disease&#xD;
&#xD;
          -  Any individual who is currently being treated for or diagnosed with a psychiatric&#xD;
             disorder or disease&#xD;
&#xD;
          -  Any individual who is currently being treated for or diagnosed with a hematological&#xD;
             disorder or disease&#xD;
&#xD;
          -  Any individual who is currently being treated for or diagnosed with a neurological&#xD;
             disorder or disease&#xD;
&#xD;
          -  Any individual who is currently being treated for or diagnosed with an&#xD;
             endocrinological disorder or disease&#xD;
&#xD;
          -  Participants who are determined to not be weight stable defined as measured body mass&#xD;
             deviating by 2% or more.&#xD;
&#xD;
          -  Participants who do not or are not willing to abstain from alcohol, nicotine, and&#xD;
             caffeine for 12 hours prior to each visit will be excluded&#xD;
&#xD;
          -  Participants who do not or are not willing to abstain from exercise for 12 hours prior&#xD;
             to each visit will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chad Kerksick, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Laboratory Director</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lindenwood University</name>
      <address>
        <city>Saint Charles</city>
        <state>Missouri</state>
        <zip>63301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Caseins</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All approved unidentified study data inside the laboratory will be saved within a research repository bank for future research questions. Otherwise, participant data will be destroyed after three years of study completion to maintain IRB compliance.</ipd_description>
  </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/NCT04427020
org study id: IRB-20-15
nct id: NCT04427020
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine the pharmacokinetic pattern of amino acid absorption
      after a two-week pattern of milk protein supplementation with and without the addition of
      Bacillus coagulans GBI-30, 6086.
The study will be conducted using a randomized, double-blind, crossover study design. 30
      healthy men and women between the ages of 18 - 55 years of age will be recruited to
      participate in this study. Prior to beginning the study, all participants will sign an
      IRB-approved informed consent document and complete a healthy history questionnaire to
      determine study eligibility. Two supplementation protocols that each span two weeks will be
      completed and separated with a washout period of three weeks. For each study visit, all
      participants will report to the laboratory between 0600 - 1000 hours after observing an 8 -
      10-hour fast. For two weeks prior to each study visit, participants will be assigned in a
      randomized, double-blind, crossover fashion to ingest a single daily 25-gram dose of a milk
      protein concentrate or a similar dose of milk protein concentrate plus bacillus coagulans
      GBI-30, 6086. Upon arrival for each study visit, participants will have their resting heart
      rate, blood pressure, body mass, height, and body composition measured using bioelectrical
      impedance analysis (BIA). Upon ingestion of their final assigned supplementation dose,
      standard multiple sample phlebotomy approaches will used to collect approximately 10mL of
      venous blood from a forearm vein before (0 min), 30, 60, 90, 120, 180, and 240 minutes after
      ingestion of their final assigned supplementation dose for that period in the study protocol.
      Participants will be provided 200 mL of cold water to ingest after each blood collection.
      Upon processing, all blood samples will be stored at -80 C. All samples will o be discarded
      according to Institutional Review Board-stipulated guidelines. Study participants will be
      provided an additional two-week supply of the alternative treatment to begin after observing
      a three-week washout. After two weeks of supplementation, study participants will return to
      the laboratory for their remaining testing visit. All subsequent study visits will be
      completed in a randomized fashion to minimize any order effects from testing.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
masking description: Protein and probiotics were delivered separately. Upon arrival a faculty member (who was not an investigator) blinded both the protein and probiotic samples and kept the code sealed in an envelope until all statistical analysis was complete. Once all data collection, data entry, and statistical analysis was completely finished, the study code was broken.
measure: Rate of amino acid absorption
time frame: seven weeks
description: We intend to determine if the addition of a probiotic to milk protein ingestion changes the rate (in minutes) to which amino acids are absorbed into our bloodstream.
measure: Concentration of amino acid absorption
time frame: seven weeks
description: We intend to determine if the addition of a probiotic to milk protein ingestion changes the extent (concentration in millimoles/Liter) to which amino acids are absorbed into our bloodstream.
arm group label: Milk Protein + Probiotic
arm group type: Experimental
description: 25 gram dose of milk protein concentrate with bacillus coagulans GBI-30, 6086
arm group label: Milk Protein
arm group type: Active Comparator
description: 25 gram dose of milk protein concentrate
intervention type: Dietary Supplement
intervention name: Milk protein + GBI-30
description: Both conditions matched flavor, color, and serving size
arm group label: Milk Protein + Probiotic
intervention type: Dietary Supplement
intervention name: Milk protein
description: Both conditions matched flavor, color, and serving size
arm group label: Milk Protein
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chad Kerksick, PhD
role: Study Director
affiliation: Laboratory Director
facility: 
country: United States
responsible party type: Sponsor
mesh term: Caseins
sharing ipd: No
ipd description: All approved unidentified study data inside the laboratory will be saved within a research repository bank for future research questions. Otherwise, participant data will be destroyed after three years of study completion to maintain IRB compliance.