<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/NCT03259997</url>
  </required_header>
  <id_info>
    <org_study_id>ProFormance135</org_study_id>
    <nct_id>NCT03259997</nct_id>
  </id_info>
  <brief_title>Efficacy of Probiotics on Physical Performance</brief_title>
  <official_title>Efficacy of Probiotics on Physical Performance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Probi AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Probi AB</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>
      Efficacy of probiotics on physical performance&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2017</start_date>
  <completion_date type="Actual">May 9, 2018</completion_date>
  <primary_completion_date type="Actual">May 9, 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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Metabolic response at standardized workloads during ergometer cycling</measure>
    <time_frame>4,8 and 12 weeks</time_frame>
    <description>Change from baseline in metabolic response at standardized workloads during ergometer cycling after 4,8 and 12 weeks of supplementation</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Physical Performance</condition>
  <arm_group>
    <arm_group_label>Probiotic supplement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic supplement</intervention_name>
    <description>Probiotic supplement</description>
    <arm_group_label>Probiotic supplement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, aged 18 to 40 years, at the time of signing the informed consent form&#xD;
&#xD;
          -  Provides signed and dated informed consent form&#xD;
&#xD;
          -  Engaged in competitive sports and regularly training&#xD;
&#xD;
          -  Non-anemic, iron-deficient&#xD;
&#xD;
          -  Willing to comply with all study procedures and be available for the duration of the&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of probiotics&#xD;
&#xD;
          -  Use of iron supplementation&#xD;
&#xD;
          -  Use of ascorbic acid (Vitamin C) supplementation&#xD;
&#xD;
          -  Hypersensitivity to any of the ingredients in the investigational product (IP)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Svensson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Umeå University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Idrottsmedicinska enheten, Umeå universitet</name>
      <address>
        <city>Umeå</city>
        <zip>90187</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>March 19, 2019</last_update_submitted>
  <last_update_submitted_qc>March 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2019</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/NCT03259997
org study id: ProFormance135
nct id: NCT03259997
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Efficacy of probiotics on physical performance
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Metabolic response at standardized workloads during ergometer cycling
time frame: 4,8 and 12 weeks
description: Change from baseline in metabolic response at standardized workloads during ergometer cycling after 4,8 and 12 weeks of supplementation
arm group label: Probiotic supplement
arm group type: Active Comparator
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Probiotic supplement
description: Probiotic supplement
arm group label: Probiotic supplement
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Svensson, PhD
role: Principal Investigator
affiliation: Umeå University
facility: 
country: Sweden
responsible party type: Sponsor
sharing ipd: No