<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/NCT03233256</url>
  </required_header>
  <id_info>
    <org_study_id>16-2203</org_study_id>
    <secondary_id>R21DK113401</secondary_id>
    <nct_id>NCT03233256</nct_id>
  </id_info>
  <brief_title>Measurements of Water in Breath and Saliva</brief_title>
  <official_title>Rapid Measurements of Water Isotopes in Human Breath and Saliva for Doubly Labeled Water Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</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 proposes to demonstrate the feasibility of measuring 2H:1H and 18O:16O in saliva&#xD;
      and breath by comparing the natural abundances of 2H:1H and 18O:16O in saliva and urine of&#xD;
      un-dosed humans.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The scientific premises for this line of research are 1) challenges related to costs, the&#xD;
      complexity of sample collection and preparation, and the level of technical skills required&#xD;
      for Isotope-ratio mass spectrometry (IRMS) analysis have limited the adoption of the doubly&#xD;
      labeled water (DLW) method; and 2) the investigators preliminary data demonstrates that&#xD;
      Off-Axis Integrated Cavity Output Spectroscopy (OA-ICOS) provides a valid, more rapid, and&#xD;
      less technically challenging approach to isotopic analysis of human samples.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">February 27, 2018</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>
    <intervention_model_description>Healthy adults (18-45 yrs.) will be recruited from the local Denver area. The investigators have elected to study a relatively homogenous sample to limit the impact of age, weight, and chronic disease on isotope fractionation in breath.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Natural abundances of 2H:1H and 18O:16O in humans</measure>
    <time_frame>Baseline</time_frame>
    <description>Evaluation of the natural abundances of 2H:1H and 18O:16O in urine, saliva, and breath of humans.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Human Energy Expenditure</condition>
  <arm_group>
    <arm_group_label>Healthy adults (18-45 yrs.)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy adults (18-45 yrs.) will be recruited from the local Denver area. The investigators have elected to study a relatively homogenous sample to limit the impact of age, weight, and chronic disease on isotope fractionation in breath.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Feasibility of measuring 2H:1H and 18O:16O in saliva and breath.</intervention_name>
    <description>The investigators propose to demonstrate the feasibility of measuring 2H:1H and 18O:16O in saliva and breath. The natural abundances of 2H:1H and 18O:16O of urine, saliva, and breath samples will be determined from samples obtained simultaneously from 50 relatively healthy human subjects. We will also measure 2H:1H and 18O:16O enrichments in urine, saliva, and breath of 10 relatively healthy human subjects obtained after consuming a standard DLW dose and compare the estimates of TDEE using these different matrices.</description>
    <arm_group_label>Healthy adults (18-45 yrs.)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult men and women, aged 18-45 yrs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Obesity (body mass index (BMI) &gt; 30 kg/m2)&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Self-reported acute or chronic disease (diabetes, heart diseases, thyroid diseases)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edward L Melanson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Edward Melanson</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>April 6, 2023</last_update_submitted>
  <last_update_submitted_qc>April 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2023</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/NCT03233256
org study id: 16-2203
secondary id: R21DK113401
nct id: NCT03233256
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study proposes to demonstrate the feasibility of measuring 2H:1H and 18O:16O in saliva
      and breath by comparing the natural abundances of 2H:1H and 18O:16O in saliva and urine of
      un-dosed humans.
The scientific premises for this line of research are 1) challenges related to costs, the
      complexity of sample collection and preparation, and the level of technical skills required
      for Isotope-ratio mass spectrometry (IRMS) analysis have limited the adoption of the doubly
      labeled water (DLW) method; and 2) the investigators preliminary data demonstrates that
      Off-Axis Integrated Cavity Output Spectroscopy (OA-ICOS) provides a valid, more rapid, and
      less technically challenging approach to isotopic analysis of human samples.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Healthy adults (18-45 yrs.) will be recruited from the local Denver area. The investigators have elected to study a relatively homogenous sample to limit the impact of age, weight, and chronic disease on isotope fractionation in breath.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Natural abundances of 2H:1H and 18O:16O in humans
time frame: Baseline
description: Evaluation of the natural abundances of 2H:1H and 18O:16O in urine, saliva, and breath of humans.
arm group label: Healthy adults (18-45 yrs.)
arm group type: Experimental
description: Healthy adults (18-45 yrs.) will be recruited from the local Denver area. The investigators have elected to study a relatively homogenous sample to limit the impact of age, weight, and chronic disease on isotope fractionation in breath.
intervention type: Procedure
intervention name: Feasibility of measuring 2H:1H and 18O:16O in saliva and breath.
description: The investigators propose to demonstrate the feasibility of measuring 2H:1H and 18O:16O in saliva and breath. The natural abundances of 2H:1H and 18O:16O of urine, saliva, and breath samples will be determined from samples obtained simultaneously from 50 relatively healthy human subjects. We will also measure 2H:1H and 18O:16O enrichments in urine, saliva, and breath of 10 relatively healthy human subjects obtained after consuming a standard DLW dose and compare the estimates of TDEE using these different matrices.
arm group label: Healthy adults (18-45 yrs.)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Edward L Melanson, PhD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No