<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/NCT04476238</url>
  </required_header>
  <id_info>
    <org_study_id>2020-01026</org_study_id>
    <nct_id>NCT04476238</nct_id>
  </id_info>
  <brief_title>Inosine Energy Expenditure Study</brief_title>
  <acronym>InoBAT</acronym>
  <official_title>Randomized Cross-over Trial to Investigate the Effect of Inosine on Human Energy Expenditure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      Investigators want to test whether the intake of the nucleoside inosine increases the human&#xD;
      energy expenditure. Inosine occurs as a metabolic intermediate in the human body and is&#xD;
      sometimes taken as a dietary supplement by athletes.&#xD;
&#xD;
      For this purpose, investigators will measure the basal metabolic rate by indirect&#xD;
      calorimetry. Study participants will then take inosine dissolved in water or placebo and&#xD;
      energy expenditure will be assessed again.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 28, 2022</start_date>
  <completion_date type="Anticipated">April 2023</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>resting energy expenditure after Inosine</measure>
    <time_frame>one hour after oral intake of inosine</time_frame>
    <description>resting energy expenditure (REE) assessed by indirect calorimetry after oral intake of two grams of inosine as compared to placebo</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in energy expenditure</measure>
    <time_frame>one hour after oral intake of inosine</time_frame>
    <description>- Difference in EE between baseline measurement and measurement one hour after administration of inosine or control, respectively, at each study visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Respiratory Quotient</measure>
    <time_frame>one hour after oral intake of inosine</time_frame>
    <description>- Respiratory quotient (RQ) as an indicator of substrate oxidation one hour after oral intake of two grams of inosine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum inosine level</measure>
    <time_frame>0 hours, 1 hour, 2 hours</time_frame>
    <description>Serum inosine levels after ingestion of inosine</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">8</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Inosine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 grams of inosine dissolved in 250 ml of tap water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Water</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>250 ml of tap water only</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Inosine</intervention_name>
    <description>2 grams of inosine dissolved in 250 ml water taken by mouth</description>
    <arm_group_label>Inosine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>250 ml water taken by mouth</description>
    <arm_group_label>Water</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male volunteers&#xD;
&#xD;
          -  BMI between 18-27 kg/m2&#xD;
&#xD;
          -  Age between 18 and 40 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic concomitant disease states (e.g., renal failure, hepatic dysfunction,&#xD;
             cardiovascular disease, diabetes mellitus),&#xD;
&#xD;
          -  Known or suspected non-compliance, drug or alcohol abuse,&#xD;
&#xD;
          -  Inability to follow the procedures of the study&#xD;
&#xD;
          -  Participation in another study with investigational drug within the 30 days preceding&#xD;
             and during the present study,&#xD;
&#xD;
          -  Previous enrolment into the current study,&#xD;
&#xD;
          -  Enrolment of the investigator, his/her family members, employees and other dependent&#xD;
             persons,&#xD;
&#xD;
          -  Thyroid disorders&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital Basel, Department of Endocrinology</name>
      <address>
        <city>Basel</city>
        <state>BS</state>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>March 6, 2023</last_update_submitted>
  <last_update_submitted_qc>March 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Energy expenditure</keyword>
  <keyword>metabolism</keyword>
  <keyword>inosine</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/NCT04476238
org study id: 2020-01026
nct id: NCT04476238
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigators want to test whether the intake of the nucleoside inosine increases the human
      energy expenditure. Inosine occurs as a metabolic intermediate in the human body and is
      sometimes taken as a dietary supplement by athletes.

      For this purpose, investigators will measure the basal metabolic rate by indirect
      calorimetry. Study participants will then take inosine dissolved in water or placebo and
      energy expenditure will be assessed again.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: resting energy expenditure after Inosine
time frame: one hour after oral intake of inosine
description: resting energy expenditure (REE) assessed by indirect calorimetry after oral intake of two grams of inosine as compared to placebo
measure: Change in energy expenditure
time frame: one hour after oral intake of inosine
description: - Difference in EE between baseline measurement and measurement one hour after administration of inosine or control, respectively, at each study visit.
measure: Change in Respiratory Quotient
time frame: one hour after oral intake of inosine
description: - Respiratory quotient (RQ) as an indicator of substrate oxidation one hour after oral intake of two grams of inosine
measure: Serum inosine level
time frame: 0 hours, 1 hour, 2 hours
description: Serum inosine levels after ingestion of inosine
arm group label: Inosine
arm group type: Experimental
description: 2 grams of inosine dissolved in 250 ml of tap water
arm group label: Water
arm group type: Placebo Comparator
description: 250 ml of tap water only
intervention type: Dietary Supplement
intervention name: Inosine
description: 2 grams of inosine dissolved in 250 ml water taken by mouth
arm group label: Inosine
intervention type: Other
intervention name: Placebo
description: 250 ml water taken by mouth
arm group label: Water
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Switzerland
responsible party type: Sponsor
sharing ipd: No