<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/NCT02971787</url>
  </required_header>
  <id_info>
    <org_study_id>Tissue Salt 5</org_study_id>
    <nct_id>NCT02971787</nct_id>
  </id_info>
  <brief_title>Salt Intake and Lactobacillus Abundance</brief_title>
  <official_title>Influence of Increased Salt Intake on Lactobacillus Abundance in Healthy Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the influence of an increased salt intake (6 g/d for 14 days) on the relative&#xD;
      abundance of gut lactobillus species in healthy men&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decrease of relative abundance of four lactobacillus species</measure>
    <time_frame>14 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Increase of systolic blood pressure</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increase of pulse wave velocity</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increase of lymphocytic pro-inflammatory mediators</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Healthy Volunteers</condition>
  <condition>Probiotics</condition>
  <condition>Sodium</condition>
  <arm_group>
    <arm_group_label>Probiotics and salt</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lactobacillus enrichment and salt increase</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotics</intervention_name>
    <description>Day 1-21: 2 capsules per day</description>
    <arm_group_label>Probiotics and salt</arm_group_label>
    <other_name>Vivomixx</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Salt</intervention_name>
    <description>Day 8-21: 10 tablets à 600 mg per day</description>
    <arm_group_label>Probiotics and salt</arm_group_label>
    <other_name>Slow Sodium Tablets</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy men&#xD;
&#xD;
          -  18 - 50 years&#xD;
&#xD;
          -  Body mass index 18,5 - 29,9 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically relevant heart, lung, liver, and kidney disease&#xD;
&#xD;
          -  Current or chronic infections&#xD;
&#xD;
          -  Habitual intake of probiotics or dietary supplements&#xD;
      </textblock>
    </criteria>
    <gender>Male</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>Anja Maehler, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Experimental and Clinical Research Center</name>
      <address>
        <city>Berlin</city>
        <zip>13125</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04973-0</url>
    <description>Follow-up study</description>
  </link>
  <results_reference>
    <citation>Mahler A, Wilck N, Rauch G, Dechend R, Muller DN. Effect of a probiotic on blood pressure in grade 1 hypertension (HYPRO): protocol of a randomized controlled study. Trials. 2020 Dec 29;21(1):1032. doi: 10.1186/s13063-020-04973-0.</citation>
    <PMID>33375942</PMID>
  </results_reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>July 7, 2022</last_update_submitted>
  <last_update_submitted_qc>July 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Anja Maehler</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </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/NCT02971787
org study id: Tissue Salt 5
nct id: NCT02971787
lead sponsor: 
has dmc: No
To investigate the influence of an increased salt intake (6 g/d for 14 days) on the relative
      abundance of gut lactobillus species in healthy men
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Decrease of relative abundance of four lactobacillus species
time frame: 14 days
measure: Increase of systolic blood pressure
time frame: 14 days
measure: Increase of pulse wave velocity
time frame: 14 days
measure: Increase of lymphocytic pro-inflammatory mediators
time frame: 14 days
arm group label: Probiotics and salt
arm group type: Experimental
description: Lactobacillus enrichment and salt increase
intervention type: Dietary Supplement
intervention name: Probiotics
description: Day 1-21: 2 capsules per day
arm group label: Probiotics and salt
other name: Vivomixx
intervention type: Dietary Supplement
intervention name: Salt
description: Day 8-21: 10 tablets à 600 mg per day
arm group label: Probiotics and salt
other name: Slow Sodium Tablets
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anja Maehler, PhD
role: Principal Investigator
affiliation: Charite University, Berlin, Germany
facility: 
country: Germany
url: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04973-0
description: Follow-up study
citation: Mahler A, Wilck N, Rauch G, Dechend R, Muller DN. Effect of a probiotic on blood pressure in grade 1 hypertension (HYPRO): protocol of a randomized controlled study. Trials. 2020 Dec 29;21(1):1032. doi: 10.1186/s13063-020-04973-0.
PMID: 33375942
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Anja Maehler
investigator title: Principle Investigator
sharing ipd: No