<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/NCT04441840</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-19-161</org_study_id>
    <nct_id>NCT04441840</nct_id>
  </id_info>
  <brief_title>Immune and Recovery Modulating Impact of Probiotic Supplementation After Intense Resistance Exercise</brief_title>
  <official_title>Immune and Recovery Modulating Impact of Probiotic Supplementation After Intense Resistance Exercise</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>
      This study proposal seeks to examine the efficacy of probiotic supplementation at mitigating&#xD;
      changes in immune function and recovery after completion of intense, stressful exercise while&#xD;
      also allowing for a better understanding of its ability to promote recovery and maintenance&#xD;
      of physical performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Visit 1 - Familiarization:&#xD;
&#xD;
      During the familiarization visit, participants will first read and sign an IRB-approved&#xD;
      informed consent document and complete a short form of the International Physical Activity&#xD;
      Questionnaire (IPAQ). Participants will then have their height, weight, and body composition&#xD;
      determined using Dual-Energy X-ray Absorptiometry (DEXA) (Hologic Discovery A). To&#xD;
      standardize body composition assessment, participants will be required to observe an 8-hour&#xD;
      fast and maintain a well-hydrated state. Each participant will provide a urine sample to&#xD;
      confirm a hydrated stated through determination of a urine specific gravity values greater&#xD;
      1.020. Participants will then complete a peak oxygen consumption test (VO2Peak) using&#xD;
      indirect calorimetry on a ParvoMedics TrueOne (Sandy, UT) metabolic cart interfaced to a&#xD;
      motorized cycle ergometer (Lode Corival). The peak oxygen consumption test protocol will&#xD;
      require each study participants to start at 100 watts before progressively increasing by 1&#xD;
      watt every two seconds. To determine whether maximal effort occurred a respiratory exchange&#xD;
      ratio of &gt;1.00 must be achieved.&#xD;
&#xD;
      Following the peak oxygen consumption assessment, participants will perform practice&#xD;
      repetitions of all performance tests (force plate vertical jumps, isometric mid-thigh pulls,&#xD;
      Biodex isometric and isokinetic knee extensor testing) as well as the exercises that will be&#xD;
      performed during Visit 3 (leg press, hex bar deadlift, and drop jump).&#xD;
&#xD;
      Study Visit 2 - Pre-Supplementation Baseline Testing:&#xD;
&#xD;
      Study participants will be asked to complete a 24-hour food recall between each testing&#xD;
      condition and will be asked to replicate their diet prior to this visit for all subsequent&#xD;
      visits. Upon arrival, participants will first have their blood drawn from a forearm vein&#xD;
      before completing a perceived soreness, pressure-pain threshold, and recovery assessment.&#xD;
      Prior to testing, participants will complete the same standardized warm-up consisting of 5&#xD;
      minutes of light cycling, 10 body weight squats, 10 body weight walking lunges, 10 dynamic&#xD;
      walking hamstring stretches (straight-leg march), and 10 dynamic walking quadriceps&#xD;
      stretches. After the warm-up, participants will complete five countermovement jump squats on&#xD;
      top of bilateral triaxial force plates (Hawkins Dynamics) interfaced to a personal computer&#xD;
      to derive relevant force-time variables. Next, participants will complete two assessments of&#xD;
      peak isometric force production. Using an electronic load cell with a 5,000-N capacity (Load&#xD;
      Star load cells) connected to a computer, three 5-second maximal isometric mid-thigh pulls&#xD;
      will be completed. Participants will then be outfitted on a Biodex isokinetic dynamometer&#xD;
      where they will complete three maximal isometric knee extensions. Following the isometric&#xD;
      knee extensor testing, participants will complete a 50-repetition test of concentric-only&#xD;
      repetitions to assess changes in force production, torque, and rates of fatigue development.&#xD;
      After the baseline performance testing, participants will have their leg press and hex bar&#xD;
      deadlift one-repetition maximum (1RM) determined.&#xD;
&#xD;
      *Supplementation (14 days, described below) followed by exercise trial.*&#xD;
&#xD;
      Study Visit 3 (Post-Supplementation Testing, Exercise Trial):&#xD;
&#xD;
      Upon arrival, study participants will be asked to complete a 24-hour food recall and between&#xD;
      each testing condition, study participants will be asked to replicate their diet. Upon&#xD;
      arrival, participants will first have their blood drawn from a forearm vein before completing&#xD;
      perceived soreness, pressure-pain threshold, and recovery assessments. Prior to testing,&#xD;
      participants will complete the same standardized warm-up consisting of 5 minutes of light&#xD;
      cycling, 10 body weight squats, 10 body weight walking lunges, 10 dynamic walking hamstring&#xD;
      stretches (straight-leg march), and 10 dynamic walking quadriceps stretches. After the&#xD;
      warm-up, participants will complete five countermovement jump squats on top of bilateral&#xD;
      triaxial force plates (Hawkins Dynamics) interfaced to a personal computer to derive relevant&#xD;
      force-time variables. Using an electronic load cell with a 5,000-N capacity (Load Star load&#xD;
      cells) connected to a computer, three 5-second maximal isometric mid-thigh pulls will be&#xD;
      completed. Participants will then be positioned on a Biodex isokinetic dynamometer where they&#xD;
      will complete three maximal isometric knee extensions. Lastly, participants will complete a&#xD;
      50-repetition test of concentric-only repetitions to assess changes in force production,&#xD;
      torque, and rates of fatigue development. Following the completion of these tests,&#xD;
      participants will perform an exercise trial according to the methods described below.&#xD;
      Following completion of the exercise trial, participants will undergo the previous testing&#xD;
      battery (blood sample, perceived soreness, pressure-pain threshold assessment, recovery&#xD;
      assessment, countermovement vertical jumps, isometric mid-thigh pulls, Biodex isometric and&#xD;
      isokinetic testing) at five time points: immediately after exercise, 30 minutes&#xD;
      post-exercise, 1 hour, 2 hours, and 5 hours post-exercise.&#xD;
&#xD;
      Study Visits 4 - 6: Post-Exercise Performance In an identical fashion, with the exception of&#xD;
      1RM assessment, study visits 4, 5, and 6 will be completed 24, 48, and 72 hours,&#xD;
      respectively, after completion of the exercise bout. Briefly, study participants will return&#xD;
      to the laboratory after an overnight fast (10 hours). Participants will bring in the&#xD;
      completed 24-hour dietary recall, donate venous blood samples, assess their soreness,&#xD;
      pressure-pain threshold, and recovery, complete the warm-up, perform five countermovement&#xD;
      jumps, assess peak isometric force production, and complete a 50-repetition muscle fatigue&#xD;
      test during each visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 16, 2019</start_date>
  <completion_date type="Actual">August 1, 2021</completion_date>
  <primary_completion_date type="Actual">August 1, 2021</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>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>The supplements were delivered in identical containers, each marked with a separate code marked on the outside of the supplement container. Once data collection, data entry, and statistical analysis was completely finished, the study code was broken.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Immune Markers</measure>
    <time_frame>Three weeks</time_frame>
    <description>C-reactive protein [milligrams per liter (mg/L)]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complete blood count</measure>
    <time_frame>Three weeks</time_frame>
    <description>White blood cell and platelet count [Thousand per microliter (Thousand/uL)]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Markers of muscle damage</measure>
    <time_frame>Three weeks</time_frame>
    <description>Creatine kinase [Units per liter (U/L)]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Force production assessment</measure>
    <time_frame>Three weeks</time_frame>
    <description>Maximal voluntary isometric contraction (knee extension) [pounds (lb)]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Force production assessment</measure>
    <time_frame>Three weeks</time_frame>
    <description>Isometric mid-thigh pull [pounds (lb)]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Countermovement Jump</measure>
    <time_frame>Three weeks</time_frame>
    <description>peak force [Newtons (N)]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Countermovement Jump</measure>
    <time_frame>Three weeks</time_frame>
    <description>eccentric force [Newtons (N)]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Countermovement Jump</measure>
    <time_frame>Three weeks</time_frame>
    <description>eccentric rate of force development [Newtons (N)]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Countermovement Jump</measure>
    <time_frame>Three weeks</time_frame>
    <description>reactive strength index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dynamic muscular fatigue</measure>
    <time_frame>Three weeks</time_frame>
    <description>Biodex 50-repetition test [Percent fatigue rate]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived soreness</measure>
    <time_frame>Three weeks</time_frame>
    <description>Soreness questionnaire (0 - 10) 0 is low, 10 is high</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived soreness</measure>
    <time_frame>Three weeks</time_frame>
    <description>pain-pressure threshold via algometer [Newtons (N)]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immune Marker</measure>
    <time_frame>Three weeks</time_frame>
    <description>Interleukin-6, Tumor necrosis factor-alpha, Monocyte chemoattractant protein 1 [picograms per milliliter (pg/mL)]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Markers of muscle damage</measure>
    <time_frame>Three weeks</time_frame>
    <description>Myoglobin [nanogram per milliliter (ng/mL)].</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complete blood count (CBC)</measure>
    <time_frame>Three weeks</time_frame>
    <description>Red blood cell count [Millions per microliter (million/uL)]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complete blood count (CBC)</measure>
    <time_frame>Three weeks</time_frame>
    <description>Hemoglobin and Mean corpuscular hemoglobin concentration (MCHC) [grams per deciliter (g/dL)]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complete blood count (CBC)</measure>
    <time_frame>Three weeks</time_frame>
    <description>Hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, basophils,Red cell distribution width (RDW) [Percentage (%)]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complete blood count (CBC)</measure>
    <time_frame>Three weeks</time_frame>
    <description>Mean corpuscular volume (MCV) and Mean platelet volume (MPV) [Femtoliters (fL)]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complete blood count (CBC)</measure>
    <time_frame>Three weeks</time_frame>
    <description>Mean corpuscular hemoglobin (MCH) [Picograms (pg)]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complete blood count (CBC)</measure>
    <time_frame>Three weeks</time_frame>
    <description>Absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils [cells per microliter (cells/uL)]</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Immune Markers</condition>
  <condition>Complete Blood Count (CBC) With Platelet Differentials</condition>
  <condition>Muscle Damage</condition>
  <condition>Muscular Force Production</condition>
  <condition>Countermovement Jump</condition>
  <condition>Muscular Fatigue</condition>
  <condition>Muscular Soreness</condition>
  <arm_group>
    <arm_group_label>Active Probiotic Culture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active culture of Bacillus Coagulans Dose: 1 x 10^9 colony forming units (CFU)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inactive Probiotic Culture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Inactive culture of Bacillus Coagulans (GBI-30, 6086) - Marked as &quot;StaImune&quot; Dose: 1 x 10^9 colony forming units (CFU)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Active Probiotic Culture</intervention_name>
    <description>Both conditions matched in appearance and serving size</description>
    <arm_group_label>Active Probiotic Culture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Inactive Probiotic Culture</intervention_name>
    <description>Both conditions matched in appearance and serving size</description>
    <arm_group_label>Inactive Probiotic Culture</arm_group_label>
    <other_name>StaImune</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Free from any disorders or diseases as stated on health history form&#xD;
&#xD;
          -  Between the ages of 18 - 55 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently being treated for or are diagnosed with a cardiac, respiratory, circulatory,&#xD;
             musculoskeletal, metabolic, obesity (defined as body mass index &gt; 30 kg/m2 and body&#xD;
             fat greater than 30%), immune, autoimmune, hematological, neurological or&#xD;
             endocrinological disorder or disease unless the scenario is viewed to not be a&#xD;
             contraindication by the clinical coordinator of the study protocol. Individuals who&#xD;
             are currently prescribed a hypertensive or cholesterol-lowering medication will be&#xD;
             allowed entry into the study with clearance from clinical coordinator or their&#xD;
             personal physician.&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  An individual who is less than 18 and greater than 55 years of age will be excluded.&#xD;
&#xD;
          -  Participants younger than 18 are excluded due to necessity of parental consent.&#xD;
&#xD;
          -  Participants greater than 55 years old lie outside of the target demographic for the&#xD;
             current study.&#xD;
&#xD;
          -  Considered to be sedentary, defined as getting less than 30 minutes of moderate&#xD;
             intensity physical activity for most days of the week.&#xD;
&#xD;
          -  Currently not resistance training at least 2 days per week for the past 30 days&#xD;
&#xD;
          -  Currently smoking or have quit smoking within the past 6 months&#xD;
&#xD;
          -  Currently taking a probiotic. Individuals who currently report as taking a probiotic&#xD;
             will be allowed entry into study protocol if a wash-out period of 30 days is&#xD;
             observed.)&#xD;
&#xD;
          -  Currently consuming any form of dietary supplements that are viewed by study&#xD;
             investigators to confound the outcomes of the study protocol (i.e., creatine,&#xD;
             beta-alanine, essential amino acids, beta-hydroxy-beta-methylbutyrate (HMB),&#xD;
             branched-chain amino acids, or any pre-workout that contain combinations of these&#xD;
             ingredients). Individuals who currently report as taking any of these supplements will&#xD;
             be allowed entry into study protocol if a wash-out period of 30 days is observed.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chad Kerksick, PhD</last_name>
    <role>Principal Investigator</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>April 2022</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>April 4, 2022</last_update_submitted>
  <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_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 Institutional Review Board (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/NCT04441840
org study id: IRB-19-161
nct id: NCT04441840
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study proposal seeks to examine the efficacy of probiotic supplementation at mitigating
      changes in immune function and recovery after completion of intense, stressful exercise while
      also allowing for a better understanding of its ability to promote recovery and maintenance
      of physical performance.
Study Visit 1 - Familiarization:

      During the familiarization visit, participants will first read and sign an IRB-approved
      informed consent document and complete a short form of the International Physical Activity
      Questionnaire (IPAQ). Participants will then have their height, weight, and body composition
      determined using Dual-Energy X-ray Absorptiometry (DEXA) (Hologic Discovery A). To
      standardize body composition assessment, participants will be required to observe an 8-hour
      fast and maintain a well-hydrated state. Each participant will provide a urine sample to
      confirm a hydrated stated through determination of a urine specific gravity values greater
      1.020. Participants will then complete a peak oxygen consumption test (VO2Peak) using
      indirect calorimetry on a ParvoMedics TrueOne (Sandy, UT) metabolic cart interfaced to a
      motorized cycle ergometer (Lode Corival). The peak oxygen consumption test protocol will
      require each study participants to start at 100 watts before progressively increasing by 1
      watt every two seconds. To determine whether maximal effort occurred a respiratory exchange
      ratio of >1.00 must be achieved.

      Following the peak oxygen consumption assessment, participants will perform practice
      repetitions of all performance tests (force plate vertical jumps, isometric mid-thigh pulls,
      Biodex isometric and isokinetic knee extensor testing) as well as the exercises that will be
      performed during Visit 3 (leg press, hex bar deadlift, and drop jump).

      Study Visit 2 - Pre-Supplementation Baseline Testing:

      Study participants will be asked to complete a 24-hour food recall between each testing
      condition and will be asked to replicate their diet prior to this visit for all subsequent
      visits. Upon arrival, participants will first have their blood drawn from a forearm vein
      before completing a perceived soreness, pressure-pain threshold, and recovery assessment.
      Prior to testing, participants will complete the same standardized warm-up consisting of 5
      minutes of light cycling, 10 body weight squats, 10 body weight walking lunges, 10 dynamic
      walking hamstring stretches (straight-leg march), and 10 dynamic walking quadriceps
      stretches. After the warm-up, participants will complete five countermovement jump squats on
      top of bilateral triaxial force plates (Hawkins Dynamics) interfaced to a personal computer
      to derive relevant force-time variables. Next, participants will complete two assessments of
      peak isometric force production. Using an electronic load cell with a 5,000-N capacity (Load
      Star load cells) connected to a computer, three 5-second maximal isometric mid-thigh pulls
      will be completed. Participants will then be outfitted on a Biodex isokinetic dynamometer
      where they will complete three maximal isometric knee extensions. Following the isometric
      knee extensor testing, participants will complete a 50-repetition test of concentric-only
      repetitions to assess changes in force production, torque, and rates of fatigue development.
      After the baseline performance testing, participants will have their leg press and hex bar
      deadlift one-repetition maximum (1RM) determined.

      *Supplementation (14 days, described below) followed by exercise trial.*

      Study Visit 3 (Post-Supplementation Testing, Exercise Trial):

      Upon arrival, study participants will be asked to complete a 24-hour food recall and between
      each testing condition, study participants will be asked to replicate their diet. Upon
      arrival, participants will first have their blood drawn from a forearm vein before completing
      perceived soreness, pressure-pain threshold, and recovery assessments. Prior to testing,
      participants will complete the same standardized warm-up consisting of 5 minutes of light
      cycling, 10 body weight squats, 10 body weight walking lunges, 10 dynamic walking hamstring
      stretches (straight-leg march), and 10 dynamic walking quadriceps stretches. After the
      warm-up, participants will complete five countermovement jump squats on top of bilateral
      triaxial force plates (Hawkins Dynamics) interfaced to a personal computer to derive relevant
      force-time variables. Using an electronic load cell with a 5,000-N capacity (Load Star load
      cells) connected to a computer, three 5-second maximal isometric mid-thigh pulls will be
      completed. Participants will then be positioned on a Biodex isokinetic dynamometer where they
      will complete three maximal isometric knee extensions. Lastly, participants will complete a
      50-repetition test of concentric-only repetitions to assess changes in force production,
      torque, and rates of fatigue development. Following the completion of these tests,
      participants will perform an exercise trial according to the methods described below.
      Following completion of the exercise trial, participants will undergo the previous testing
      battery (blood sample, perceived soreness, pressure-pain threshold assessment, recovery
      assessment, countermovement vertical jumps, isometric mid-thigh pulls, Biodex isometric and
      isokinetic testing) at five time points: immediately after exercise, 30 minutes
      post-exercise, 1 hour, 2 hours, and 5 hours post-exercise.

      Study Visits 4 - 6: Post-Exercise Performance In an identical fashion, with the exception of
      1RM assessment, study visits 4, 5, and 6 will be completed 24, 48, and 72 hours,
      respectively, after completion of the exercise bout. Briefly, study participants will return
      to the laboratory after an overnight fast (10 hours). Participants will bring in the
      completed 24-hour dietary recall, donate venous blood samples, assess their soreness,
      pressure-pain threshold, and recovery, complete the warm-up, perform five countermovement
      jumps, assess peak isometric force production, and complete a 50-repetition muscle fatigue
      test during each visit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
masking description: The supplements were delivered in identical containers, each marked with a separate code marked on the outside of the supplement container. Once data collection, data entry, and statistical analysis was completely finished, the study code was broken.
measure: Immune Markers
time frame: Three weeks
description: C-reactive protein [milligrams per liter (mg/L)]
measure: Complete blood count
time frame: Three weeks
description: White blood cell and platelet count [Thousand per microliter (Thousand/uL)]
measure: Markers of muscle damage
time frame: Three weeks
description: Creatine kinase [Units per liter (U/L)]
measure: Force production assessment
time frame: Three weeks
description: Maximal voluntary isometric contraction (knee extension) [pounds (lb)]
measure: Force production assessment
time frame: Three weeks
description: Isometric mid-thigh pull [pounds (lb)]
measure: Countermovement Jump
time frame: Three weeks
description: peak force [Newtons (N)]
measure: Countermovement Jump
time frame: Three weeks
description: eccentric force [Newtons (N)]
measure: Countermovement Jump
time frame: Three weeks
description: eccentric rate of force development [Newtons (N)]
measure: Countermovement Jump
time frame: Three weeks
description: reactive strength index
measure: Dynamic muscular fatigue
time frame: Three weeks
description: Biodex 50-repetition test [Percent fatigue rate]
measure: Perceived soreness
time frame: Three weeks
description: Soreness questionnaire (0 - 10) 0 is low, 10 is high
measure: Perceived soreness
time frame: Three weeks
description: pain-pressure threshold via algometer [Newtons (N)]
measure: Immune Marker
time frame: Three weeks
description: Interleukin-6, Tumor necrosis factor-alpha, Monocyte chemoattractant protein 1 [picograms per milliliter (pg/mL)]
measure: Markers of muscle damage
time frame: Three weeks
description: Myoglobin [nanogram per milliliter (ng/mL)].
measure: Complete blood count (CBC)
time frame: Three weeks
description: Red blood cell count [Millions per microliter (million/uL)]
measure: Complete blood count (CBC)
time frame: Three weeks
description: Hemoglobin and Mean corpuscular hemoglobin concentration (MCHC) [grams per deciliter (g/dL)]
measure: Complete blood count (CBC)
time frame: Three weeks
description: Hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, basophils,Red cell distribution width (RDW) [Percentage (%)]
measure: Complete blood count (CBC)
time frame: Three weeks
description: Mean corpuscular volume (MCV) and Mean platelet volume (MPV) [Femtoliters (fL)]
measure: Complete blood count (CBC)
time frame: Three weeks
description: Mean corpuscular hemoglobin (MCH) [Picograms (pg)]
measure: Complete blood count (CBC)
time frame: Three weeks
description: Absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils [cells per microliter (cells/uL)]
arm group label: Active Probiotic Culture
arm group type: Active Comparator
description: Active culture of Bacillus Coagulans Dose: 1 x 10^9 colony forming units (CFU)
arm group label: Inactive Probiotic Culture
arm group type: Active Comparator
description: Inactive culture of Bacillus Coagulans (GBI-30, 6086) - Marked as "StaImune" Dose: 1 x 10^9 colony forming units (CFU)
intervention type: Dietary Supplement
intervention name: Active Probiotic Culture
description: Both conditions matched in appearance and serving size
arm group label: Active Probiotic Culture
intervention type: Dietary Supplement
intervention name: Inactive Probiotic Culture
description: Both conditions matched in appearance and serving size
arm group label: Inactive Probiotic Culture
other name: StaImune
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chad Kerksick, PhD
role: Principal Investigator
affiliation: Laboratory Director
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fatigue
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 Institutional Review Board (IRB) compliance