<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/NCT03299543</url>
  </required_header>
  <id_info>
    <org_study_id>LVL-0717</org_study_id>
    <nct_id>NCT03299543</nct_id>
  </id_info>
  <brief_title>Comparison Between Breath Acetone and Blood Beta-Hydroxybutyrate</brief_title>
  <official_title>Relationship Among Breath Acetone, Blood Beta-Hydroxybutyrate, and Blood Glucose</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medamonitor</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medamonitor</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Subjects will provide blood and breath samples to evaluate the relationship between breath&#xD;
      acetone and two blood-bound species: beta-hydroxybutyrate and glucose. Subjects will be asked&#xD;
      to provide breath and blood samples at a baseline visit and second optional visit. The two&#xD;
      visits will be spaced approximately 3 hours apart.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The LEVL device (Medamonitor, Seattle, WA) provides users a method for assessing their own&#xD;
      rate of fat metabolism. The LEVL device measures the concentration acetone in breath that the&#xD;
      scientific literature has shown to correlate to the rate of fat metabolism.&#xD;
&#xD;
      Typically, the body uses glucose to meet its metabolic energy requirements. If needed, the&#xD;
      body can shift from using glucose to using fat. Many different scenarios can cause this&#xD;
      shift. Exercise can deplete accessible carbohydrate stores causing the body to use fats for&#xD;
      energy production. Dietary changes that cause fat intake to increase and carbohydrate intake&#xD;
      to decrease will alter metabolism to efficiently utilize the change in nutrients. In all of&#xD;
      these scenarios, the body reduces it utilization of carbohydrates and, thus, shifts to using&#xD;
      fats for energy production.&#xD;
&#xD;
      When the body uses fats as an energy substrate, some of these fat molecules are converted by&#xD;
      the liver into acetoacetate, a ketone body. By enzymatic action, acetoacetate (AcAc) can be&#xD;
      converted into beta-hydroxybutyrate (BOHB). The same enzyme can generate AcAc from BOHB.&#xD;
      Additionally, acetoacetate can convert spontaneously into acetone which, due to its small&#xD;
      size and highly water solubility, can readily appear in the breath.&#xD;
&#xD;
      Currently, measurement of BOHB in blood is the gold standard for assessing ketone body&#xD;
      concentration, also known as ketosis. BOHB measurement requires an invasive finger puncture&#xD;
      to obtain blood and a costly (~$5 / test) assay. Because acetone (BrAce) is a sister ketone&#xD;
      body to BOHB, breath acetone may be used to assess ketosis and replace the measurement of&#xD;
      BOHB. Data in the scientific literature has shown BrAce to correlate with BOHB. Inferring&#xD;
      BOHB concentrations from measurement of BrAce using LEVL is less invasive and is potentially&#xD;
      less costly.&#xD;
&#xD;
      Reports have suggested that breath acetone is inversely correlated to blood sugar. However,&#xD;
      others have suggested no relationship between the two species. If a relationship does exist,&#xD;
      measurement of breath acetone could be used as a surrogate measure for blood sugar, a common&#xD;
      assay used by individuals with diabetes.&#xD;
&#xD;
      In this study, subjects will provide blood and breath samples evaluate the relationship&#xD;
      between breath acetone and two blood-bound species: BOHB and glucose. Subjects may be asked&#xD;
      to provide breath and blood samples at two different times (i.e., visits) spaced&#xD;
      approximately 3 hours apart. The second visit is not required for participation in the study&#xD;
      (i.e., optional).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2017</start_date>
  <completion_date type="Actual">February 28, 2018</completion_date>
  <primary_completion_date type="Actual">February 16, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Breath acetone concentration (ppm) will be compared against blood BOHB concentration (mM). The following methods may be used: summary statistics, plotting, and linear regression.</measure>
    <time_frame>Through study completion, 4 months</time_frame>
    <description>Both individual and average group measurements will be compared</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Breath acetone concentration (ppm) will be compared against blood glucose concentration (mg/dL). The following methods may be used: summary statistics, plotting, and linear regression.</measure>
    <time_frame>Through study completion, 4 months</time_frame>
    <description>Both individual and average group measurements will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood glucose concentration (mg/dL) will be compared against blood BOHB concentration (mM). The following methods may be used: summary statistics, plotting, and linear regression.</measure>
    <time_frame>Through study completion, 4 months</time_frame>
    <description>Both individual and average group measurements will be compared</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">61</enrollment>
  <condition>Ketosis</condition>
  <arm_group>
    <arm_group_label>Healthy adults</arm_group_label>
    <description>Healthy adults who are able to provide duplicate breath samples and pin-drop blood samples</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LEVL (Medamonitor)</intervention_name>
    <description>Subjects will provide duplicate breath samples to the LEVL device for analysis of breath acetone</description>
    <arm_group_label>Healthy adults</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy individuals&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Subject must complete the consent process&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with severe lung disease which would prevent them from providing a breath&#xD;
             sample through a large bore tube (e.g., large drinking straw)&#xD;
&#xD;
          2. Subjects with diabetes (Type 1 or Type 2)&#xD;
&#xD;
          3. Subjects who are routinely exposed to paints, paint thinners, gasoline, varnishes,&#xD;
             glues, dry cleaning solvents, or industrial cleaning products&#xD;
&#xD;
          4. Daily smoker of cigarettes, e-cigarettes, or marijuana&#xD;
&#xD;
          5. Abstain from alcohol over the prior 24 hours&#xD;
&#xD;
          6. Refrain from consumption of large amounts of garlic&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Joseph C Anderson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medamonitor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medamonitor, LLC</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>October 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>August 28, 2018</last_update_submitted>
  <last_update_submitted_qc>August 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>beta-hydroxybutyrate</keyword>
  <keyword>breath acetone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03299543
org study id: LVL-0717
nct id: NCT03299543
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Subjects will provide blood and breath samples to evaluate the relationship between breath
      acetone and two blood-bound species: beta-hydroxybutyrate and glucose. Subjects will be asked
      to provide breath and blood samples at a baseline visit and second optional visit. The two
      visits will be spaced approximately 3 hours apart.
The LEVL device (Medamonitor, Seattle, WA) provides users a method for assessing their own
      rate of fat metabolism. The LEVL device measures the concentration acetone in breath that the
      scientific literature has shown to correlate to the rate of fat metabolism.

      Typically, the body uses glucose to meet its metabolic energy requirements. If needed, the
      body can shift from using glucose to using fat. Many different scenarios can cause this
      shift. Exercise can deplete accessible carbohydrate stores causing the body to use fats for
      energy production. Dietary changes that cause fat intake to increase and carbohydrate intake
      to decrease will alter metabolism to efficiently utilize the change in nutrients. In all of
      these scenarios, the body reduces it utilization of carbohydrates and, thus, shifts to using
      fats for energy production.

      When the body uses fats as an energy substrate, some of these fat molecules are converted by
      the liver into acetoacetate, a ketone body. By enzymatic action, acetoacetate (AcAc) can be
      converted into beta-hydroxybutyrate (BOHB). The same enzyme can generate AcAc from BOHB.
      Additionally, acetoacetate can convert spontaneously into acetone which, due to its small
      size and highly water solubility, can readily appear in the breath.

      Currently, measurement of BOHB in blood is the gold standard for assessing ketone body
      concentration, also known as ketosis. BOHB measurement requires an invasive finger puncture
      to obtain blood and a costly (~$5 / test) assay. Because acetone (BrAce) is a sister ketone
      body to BOHB, breath acetone may be used to assess ketosis and replace the measurement of
      BOHB. Data in the scientific literature has shown BrAce to correlate with BOHB. Inferring
      BOHB concentrations from measurement of BrAce using LEVL is less invasive and is potentially
      less costly.

      Reports have suggested that breath acetone is inversely correlated to blood sugar. However,
      others have suggested no relationship between the two species. If a relationship does exist,
      measurement of breath acetone could be used as a surrogate measure for blood sugar, a common
      assay used by individuals with diabetes.

      In this study, subjects will provide blood and breath samples evaluate the relationship
      between breath acetone and two blood-bound species: BOHB and glucose. Subjects may be asked
      to provide breath and blood samples at two different times (i.e., visits) spaced
      approximately 3 hours apart. The second visit is not required for participation in the study
      (i.e., optional).
observational model: Cohort
time perspective: Prospective
measure: Breath acetone concentration (ppm) will be compared against blood BOHB concentration (mM). The following methods may be used: summary statistics, plotting, and linear regression.
time frame: Through study completion, 4 months
description: Both individual and average group measurements will be compared
measure: Breath acetone concentration (ppm) will be compared against blood glucose concentration (mg/dL). The following methods may be used: summary statistics, plotting, and linear regression.
time frame: Through study completion, 4 months
description: Both individual and average group measurements will be compared
measure: Blood glucose concentration (mg/dL) will be compared against blood BOHB concentration (mM). The following methods may be used: summary statistics, plotting, and linear regression.
time frame: Through study completion, 4 months
description: Both individual and average group measurements will be compared
arm group label: Healthy adults
description: Healthy adults who are able to provide duplicate breath samples and pin-drop blood samples
intervention type: Device
intervention name: LEVL (Medamonitor)
description: Subjects will provide duplicate breath samples to the LEVL device for analysis of breath acetone
arm group label: Healthy adults
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
last name: Joseph C Anderson, PhD
role: Principal Investigator
affiliation: Medamonitor
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ketosis