<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/NCT03769012</url>
  </required_header>
  <id_info>
    <org_study_id>19BIHK</org_study_id>
    <nct_id>NCT03769012</nct_id>
  </id_info>
  <brief_title>Ability of Beta-glucan Supplementation to Augment Immune Function</brief_title>
  <official_title>A Single-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Ability of Beta-glucan (to Augment Immune Function, Decrease URTI Incidence Rates, and Counter Immune Changes in Marathon Runners</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kemin Foods LC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KGK Science Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Kemin Foods LC</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 proposed study is designed to assess the efficacy of a capsule containing beta-glucan&#xD;
      taken orally daily as compared to a placebo capsule on the URTI symptoms, and the immune&#xD;
      response change in marathon runners&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At screening, an informed consent form will be given to the potential volunteer. They will be&#xD;
      required to read the information and will be given the opportunity to seek more information&#xD;
      if needed or provided with the option of taking the consent form home to review prior to&#xD;
      making their decision. If agreeable, the volunteer will sign the consent form and receive a&#xD;
      duplicate of the signed copy. Once consent has been obtained, the screening visit will&#xD;
      proceed. Each volunteer will be sequentially assigned a screening number to be entered in the&#xD;
      screening and enrollment log. Screening assessments include: review medical history, assess&#xD;
      inclusion and exclusion criteria, vitals, study diary, URTI symptom questionnaire, bowel&#xD;
      diary, and GI symptom questionnaire.&#xD;
&#xD;
      The next visit will be scheduled 14 days prior to their marathon date (baseline).&#xD;
      Participants will be reminded to complete URTI questionnaire, daily study diary, modified GI&#xD;
      symptoms and bowel diary in advance of this baseline visit. At baseline participants will&#xD;
      begin daily completion of study diaries, URTI questionnaires, daily bowel diaries, and GI&#xD;
      tolerance questionnaires. In clinic subjects will complete mood and stress questionnaires,&#xD;
      and blood sample for the analysis of CRP and NK cell activity. In addition, on the day of the&#xD;
      marathon the participant will be instructed to complete a muscle soreness assessment.&#xD;
&#xD;
      Two and four weeks post-marathon participants will return to the clinic for with unused&#xD;
      investigational product, completed study diaries, daily URTI questionnaires, daily bowel&#xD;
      diaries, and GI tolerance questionnaires. In clinic subjects will complete mood and stress&#xD;
      questionnaires, and blood sample for the analysis of CRP and NK cell activity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 27, 2018</start_date>
  <completion_date type="Actual">May 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 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>Parallel Assignment</intervention_model>
    <intervention_model_description>Single-center, randomized, double-blind, placebo-controlled, parallel study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>A randomization schedule will be created and provided to the Investigator indicating the order of randomization. Each participant will be assigned a randomization code according to the order of the randomization list generated using www.randomization.com. Enrolled participants will be randomized to the different treatment arms at day -14. Concealment of the allocation of treatment will be employed through the use of opaque sealed envelopes, each labeled with a randomization number. Each envelope will contain information regarding the treatment associated with each randomization number.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Global Cold/Flu Symptom Severity Score Wisconsin Upper Respiratory Symptom Survey (WURSS)</measure>
    <time_frame>ANOVA with 2 and 4 weeks post-marathon</time_frame>
    <description>AUC for cold/flu symptoms from Wisconsin Upper Respiratory Symptom Score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>URTI Cold/Flu Symptoms from Wisconsin Upper Respiratory Symptom Survey</measure>
    <time_frame>ANOVA with 2 and 4 weeks post-marathon</time_frame>
    <description>Total number of symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of cold/flu symptoms from Wisconsin Upper Respiratory Symptom Survey</measure>
    <time_frame>ANOVA with 2 and 4 weeks post-marathon</time_frame>
    <description>Total severity score (each symptom scored on scale of 0-no symptom to 7-severe symptom)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>URTI Episodes from Wisconsin Upper Respiratory Symptom Survey</measure>
    <time_frame>ANOVA with 2 and 4 weeks post-marathon</time_frame>
    <description>Total number of URTI Episodes/person</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sick days</measure>
    <time_frame>ANOVA with 2 and 4 weeks post-marathon</time_frame>
    <description>Total number of sick days/person</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sick days</measure>
    <time_frame>ANOVA with 2 and 4 weeks post-marathon</time_frame>
    <description>Percentage of subjects with sick days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress Level from the perceived stress scale</measure>
    <time_frame>ANOVA with 2 and 4 weeks post-marathon</time_frame>
    <description>Change from baseline on the Perceived Stress Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-Reactive Protein</measure>
    <time_frame>ANOVA with 2 and 4 weeks post-marathon</time_frame>
    <description>Change in concentration from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Natural Killer Cell Activity</measure>
    <time_frame>ANOVA with 2 and 4 weeks post-marathon</time_frame>
    <description>Change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal symptoms</measure>
    <time_frame>ANOVA with 2 and 4 weeks post-marathon</time_frame>
    <description>Total gastrointestinal symptom rating score (GSRS)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Cold</condition>
  <condition>Cold Symptom</condition>
  <condition>Flu</condition>
  <condition>Flu Symptom</condition>
  <condition>Supplement</condition>
  <condition>Stress</condition>
  <condition>Gastrointestinal Tolerance</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Beta-Glucan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Beta-Glucan</intervention_name>
    <description>95% beta-glucan sourced from whole cell Euglena Gracilis</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>microcrystalline cellulose</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and Females 21-65 years age&#xD;
&#xD;
          2. Body Mass Index (BMI) &gt; 18 kg/m2 to &lt; 34.99 kg/m2&#xD;
&#xD;
          3. Willing to wash-out for nutritional supplements known to affect immune function&#xD;
&#xD;
          4. Females of childbearing potential must agree to use a medically approved method of&#xD;
             birth control and have a negative urine pregnancy test result.&#xD;
&#xD;
          5. Agree to keep lifestyle habits consistent&#xD;
&#xD;
          6. Currently registered to participate in a full marathon and on a training regimen&#xD;
&#xD;
          7. Healthy as determined by laboratory results, medical history, and physical exam&#xD;
&#xD;
          8. Has given voluntary, written, informed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women who are pregnant, breastfeeding, or planning to become pregnant during the&#xD;
             occurrence of the trial&#xD;
&#xD;
          2. Verbal confirmation of previous major gastrointestinal surgery or other major&#xD;
             digestive disorder which may interfere with the absorption of nutrients&#xD;
&#xD;
          3. Participant has a known allergy to the test material's active or inactive ingredients&#xD;
&#xD;
          4. Chronic consumption of beta-glucan supplements&#xD;
&#xD;
          5. Consumption of anti-inflammatory medications known to affect immune function&#xD;
&#xD;
          6. On antibiotics within 4 weeks of baseline&#xD;
&#xD;
          7. Currently taking antipsychotic medications&#xD;
&#xD;
          8. Prebiotics and probiotics unless on a stable regimen&#xD;
&#xD;
          9. Verbal confirmation of Type I or Type II diabetes or clinically important renal,&#xD;
             hepatic, cardiac, pulmonary, pancreatic, neurologic, or biliary disorder, or cancer to&#xD;
             be assessed by QI&#xD;
&#xD;
         10. Verbal confirmation of a diagnosed chronic inflammatory condition&#xD;
&#xD;
         11. Verbal confirmation of autoimmune disease or if immune-compromised&#xD;
&#xD;
         12. Chronic recurring respiratory signs and symptoms due to allergies (including seasonal&#xD;
             allergies) or chronic bronchitis, asthma, or wheezing&#xD;
&#xD;
         13. Current or history (within past 6 months) of tobacco use&#xD;
&#xD;
         14. Consumption of &gt;14 standard alcoholic drinks per week&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>KGK Science Inc.</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5R8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>February 2, 2021</last_update_submitted>
  <last_update_submitted_qc>February 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT03769012
org study id: 19BIHK
nct id: NCT03769012
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This proposed study is designed to assess the efficacy of a capsule containing beta-glucan
      taken orally daily as compared to a placebo capsule on the URTI symptoms, and the immune
      response change in marathon runners
At screening, an informed consent form will be given to the potential volunteer. They will be
      required to read the information and will be given the opportunity to seek more information
      if needed or provided with the option of taking the consent form home to review prior to
      making their decision. If agreeable, the volunteer will sign the consent form and receive a
      duplicate of the signed copy. Once consent has been obtained, the screening visit will
      proceed. Each volunteer will be sequentially assigned a screening number to be entered in the
      screening and enrollment log. Screening assessments include: review medical history, assess
      inclusion and exclusion criteria, vitals, study diary, URTI symptom questionnaire, bowel
      diary, and GI symptom questionnaire.

      The next visit will be scheduled 14 days prior to their marathon date (baseline).
      Participants will be reminded to complete URTI questionnaire, daily study diary, modified GI
      symptoms and bowel diary in advance of this baseline visit. At baseline participants will
      begin daily completion of study diaries, URTI questionnaires, daily bowel diaries, and GI
      tolerance questionnaires. In clinic subjects will complete mood and stress questionnaires,
      and blood sample for the analysis of CRP and NK cell activity. In addition, on the day of the
      marathon the participant will be instructed to complete a muscle soreness assessment.

      Two and four weeks post-marathon participants will return to the clinic for with unused
      investigational product, completed study diaries, daily URTI questionnaires, daily bowel
      diaries, and GI tolerance questionnaires. In clinic subjects will complete mood and stress
      questionnaires, and blood sample for the analysis of CRP and NK cell activity.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Single-center, randomized, double-blind, placebo-controlled, parallel study
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: A randomization schedule will be created and provided to the Investigator indicating the order of randomization. Each participant will be assigned a randomization code according to the order of the randomization list generated using www.randomization.com. Enrolled participants will be randomized to the different treatment arms at day -14. Concealment of the allocation of treatment will be employed through the use of opaque sealed envelopes, each labeled with a randomization number. Each envelope will contain information regarding the treatment associated with each randomization number.
measure: Global Cold/Flu Symptom Severity Score Wisconsin Upper Respiratory Symptom Survey (WURSS)
time frame: ANOVA with 2 and 4 weeks post-marathon
description: AUC for cold/flu symptoms from Wisconsin Upper Respiratory Symptom Score
measure: URTI Cold/Flu Symptoms from Wisconsin Upper Respiratory Symptom Survey
time frame: ANOVA with 2 and 4 weeks post-marathon
description: Total number of symptoms
measure: Severity of cold/flu symptoms from Wisconsin Upper Respiratory Symptom Survey
time frame: ANOVA with 2 and 4 weeks post-marathon
description: Total severity score (each symptom scored on scale of 0-no symptom to 7-severe symptom)
measure: URTI Episodes from Wisconsin Upper Respiratory Symptom Survey
time frame: ANOVA with 2 and 4 weeks post-marathon
description: Total number of URTI Episodes/person
measure: Sick days
time frame: ANOVA with 2 and 4 weeks post-marathon
description: Total number of sick days/person
measure: Sick days
time frame: ANOVA with 2 and 4 weeks post-marathon
description: Percentage of subjects with sick days
measure: Stress Level from the perceived stress scale
time frame: ANOVA with 2 and 4 weeks post-marathon
description: Change from baseline on the Perceived Stress Scale
measure: C-Reactive Protein
time frame: ANOVA with 2 and 4 weeks post-marathon
description: Change in concentration from baseline
measure: Natural Killer Cell Activity
time frame: ANOVA with 2 and 4 weeks post-marathon
description: Change from baseline
measure: Gastrointestinal symptoms
time frame: ANOVA with 2 and 4 weeks post-marathon
description: Total gastrointestinal symptom rating score (GSRS)
arm group label: Treatment
arm group type: Experimental
description: Beta-Glucan
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Dietary Supplement
intervention name: Beta-Glucan
description: 95% beta-glucan sourced from whole cell Euglena Gracilis
arm group label: Treatment
intervention type: Dietary Supplement
intervention name: Placebo
description: microcrystalline cellulose
arm group label: Placebo
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: No