<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/NCT03024567</url>
  </required_header>
  <id_info>
    <org_study_id>Tissue Salt 4</org_study_id>
    <nct_id>NCT03024567</nct_id>
  </id_info>
  <brief_title>Randomized Study on Salt Intake and Energy Metabolism</brief_title>
  <acronym>TS4</acronym>
  <official_title>Effects of Increased Salt Intake on Energy Metabolism in Healthy Volunteers - a Randomized Clinical Study</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To perform a randomized, double-blind clinical study on the effects of an increased salt&#xD;
      intake on metabolic, cardiovascular and immunological parameters and the gut microbiota&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">July 2021</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dietary induced thermogenis (%)</measure>
    <time_frame>14 days</time_frame>
    <description>Decrease of dietary induced thermogenis after salt vs. placebo</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Systolic blood pressure (mmHg)</measure>
    <time_frame>14 days</time_frame>
    <description>Increase of systolic blood pressure after salt vs. placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lymphocytic pro-inflammatory mediators</measure>
    <time_frame>14 days</time_frame>
    <description>Increase of lymphocytic pro-inflammatory mediators after salt vs. placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gut microbiome</measure>
    <time_frame>14 days</time_frame>
    <description>Change of gut microbiome composition after salt vs. placebo</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Salt</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>6 grams sodium chloride per day for 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>6 grams gelatine per day for 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Salt</intervention_name>
    <description>10 capsules daily for 14 days</description>
    <arm_group_label>Salt</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>10 capsules daily for 14 days</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy men and women&#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 diseases&#xD;
&#xD;
          -  Current or chronic infection&#xD;
&#xD;
          -  Habitual use of probiotics or dietary supplements&#xD;
&#xD;
          -  Pregnancy, lactation&#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>
  <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://www.mdpi.com/2072-6643/14/2/253</url>
    <description>Results publication</description>
  </link>
  <results_reference>
    <citation>Mahler A, Klamer S, Maifeld A, Bartolomaeus H, Marko L, Chen CY, Forslund SK, Boschmann M, Muller DN, Wilck N. Increased Salt Intake Decreases Diet-Induced Thermogenesis in Healthy Volunteers: A Randomized Placebo-Controlled Study. Nutrients. 2022 Jan 7;14(2):253. doi: 10.3390/nu14020253.</citation>
    <PMID>35057434</PMID>
  </results_reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</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>
  <keyword>Calorimetry</keyword>
  <keyword>Blood pressure</keyword>
  <keyword>Immunophenotyping</keyword>
  <keyword>Gut microbial composition</keyword>
  <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/NCT03024567
org study id: Tissue Salt 4
nct id: NCT03024567
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To perform a randomized, double-blind clinical study on the effects of an increased salt
      intake on metabolic, cardiovascular and immunological parameters and the gut microbiota
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Dietary induced thermogenis (%)
time frame: 14 days
description: Decrease of dietary induced thermogenis after salt vs. placebo
measure: Systolic blood pressure (mmHg)
time frame: 14 days
description: Increase of systolic blood pressure after salt vs. placebo
measure: Lymphocytic pro-inflammatory mediators
time frame: 14 days
description: Increase of lymphocytic pro-inflammatory mediators after salt vs. placebo
measure: Gut microbiome
time frame: 14 days
description: Change of gut microbiome composition after salt vs. placebo
arm group label: Salt
arm group type: Active Comparator
description: 6 grams sodium chloride per day for 14 days
arm group label: Placebo
arm group type: Placebo Comparator
description: 6 grams gelatine per day for 14 days
intervention type: Dietary Supplement
intervention name: Salt
description: 10 capsules daily for 14 days
arm group label: Salt
intervention type: Dietary Supplement
intervention name: Placebo
description: 10 capsules daily for 14 days
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
url: https://www.mdpi.com/2072-6643/14/2/253
description: Results publication
citation: Mahler A, Klamer S, Maifeld A, Bartolomaeus H, Marko L, Chen CY, Forslund SK, Boschmann M, Muller DN, Wilck N. Increased Salt Intake Decreases Diet-Induced Thermogenesis in Healthy Volunteers: A Randomized Placebo-Controlled Study. Nutrients. 2022 Jan 7;14(2):253. doi: 10.3390/nu14020253.
PMID: 35057434
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Anja Maehler
investigator title: Principle Investigator
sharing ipd: No