<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/NCT03839641</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC 2018-029</org_study_id>
    <nct_id>NCT03839641</nct_id>
  </id_info>
  <brief_title>Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber</brief_title>
  <acronym>METFLEX</acronym>
  <official_title>Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pennington Biomedical Research Center</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>
      The overarching aim of this study: To determine the effect of different meal compositions&#xD;
      (high- vs. low-fat) on metabolic flexibility as it relates to meal-stimulated change in&#xD;
      respiratory quotient (ΔRQ1) and sleep (ΔRQ2) metabolic flexibility, as well as the time&#xD;
      course changes in respiratory quotient, RQ (i.e., peak RQ, time to peak RQ, nadir RQ, time to&#xD;
      nadir, slope).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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 (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overnight Respiratory Exchange Ratio</measure>
    <time_frame>12 hours</time_frame>
    <description>12-h mean of respiratory exchange ratio following each meal type.&#xD;
measurement interval = 12h following start of meal (7pm)&#xD;
The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep Respiratory Exchange Ratio</measure>
    <time_frame>3 h</time_frame>
    <description>mean of respiratory exchange ratio following each meal type during sleep period, 2am-5am., 2am-5am.&#xD;
measurement interval = 3h (2am-5am)&#xD;
The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Increase in Respiratory Exchange Ratio</measure>
    <time_frame>4 h</time_frame>
    <description>mean of peak increase in respiratory exchange ratio (Peak values - baseline values) following each meal type&#xD;
Peak values were defined as the peak respiratory exchange ratio value measured during the post-meal period, 6pm-10pm.&#xD;
Baseline values were measured 1h prior to meal (5:00-5:45pm)&#xD;
measurement interval of peak values= 4h (6pm-10pm)&#xD;
A larger value in this measurement indicates that more carbohydrate than fats were being oxidized as fuel during the measurement period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Decrease in Respiratory Exchange Ratio</measure>
    <time_frame>12 h</time_frame>
    <description>mean of peak decrease in respiratory exchange ratio (baseline values -nadir values) following each meal type&#xD;
Peak values were defined as the peak respiratory exchange ratio value measured during the post-meal period, 6pm-10pm.&#xD;
Baseline values were measured 1h prior to meal (5:00-5:45pm)&#xD;
measurement interval of nadir values= 12h (6pm-6am)&#xD;
A larger value in this measurement indicates that more fats than carbohydrate were being oxidized as fuel during the measurement period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Peak Respiratory Exchange Ratio</measure>
    <time_frame>12 h</time_frame>
    <description>Average time from meal to peak respiratory exchange ratio value&#xD;
This measurement indicates how long on average it took form the onset of the meal, 6pm, for the participants to achieve their highest/peak respiratory exchange ratio value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Nadir Respiratory Exchange Ratio</measure>
    <time_frame>12 h</time_frame>
    <description>Average time from meal to nadir respiratory exchange ratio value&#xD;
This measurement indicates how long on average it took form the onset of the meal, 6pm, for the participants to achieve their lowest/nadir respiratory exchange ratio value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Slope of Respiratory Exchange Ratio</measure>
    <time_frame>12 h</time_frame>
    <description>This value indicates the speed and magnitude of the participants change in respiratory exchange ratio between the peak and nadir values.&#xD;
A more negative value in this measurement indicates either a short time interval between the highest and lowest respiratory exchange ratio values measured and/or a large difference between the highest and lowest values of respiratory exchange ratio values measured.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>High Fat Meal First</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm 1 participants randomized to receive high fat meal first, and low fat meal second</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Fat Meal Second</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm 2 participants randomized to receive low fat meal first, and high fat meal second</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High fat meal</intervention_name>
    <description>60% fat meal</description>
    <arm_group_label>High Fat Meal First</arm_group_label>
    <arm_group_label>High Fat Meal Second</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low fat meal</intervention_name>
    <description>20% fat meal</description>
    <arm_group_label>High Fat Meal First</arm_group_label>
    <arm_group_label>High Fat Meal Second</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligibility criteria include:&#xD;
&#xD;
               -  Healthy male or female&#xD;
&#xD;
               -  Ages 18-40 y&#xD;
&#xD;
               -  BMI between 20 kg/m2 and 30 kg/m2 (±0.5 kg/m2 will be accepted)&#xD;
&#xD;
               -  Are willing to consume pre-prepared meals&#xD;
&#xD;
               -  Are willing to maintain current physical activity, sleep schedule, and dietary&#xD;
                  habits during the study.&#xD;
&#xD;
               -  Medically cleared for participation in the study by Medical Investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants are ineligible to participate (or will be excluded from participating in&#xD;
             this study) if they meet any of the following criteria:&#xD;
&#xD;
               -  Unstable weight in the last 3 months [gain or loss &gt;7 lb (or 3.2 kg)]&#xD;
&#xD;
               -  Currently working shift work&#xD;
&#xD;
               -  Smoking or use of tobacco products within the last 3 months&#xD;
&#xD;
               -  Amenorrhea (or absence of regular monthly cycles)&#xD;
&#xD;
               -  History of clinically diagnosed diabetes or a fasting blood glucose &gt;126 mg/dL&#xD;
&#xD;
               -  Average screening blood pressure &gt;140/90 mmHg&#xD;
&#xD;
               -  Previous bariatric surgery (or other surgeries) for obesity or weight loss&#xD;
&#xD;
               -  Use of medications affecting metabolism or sleep&#xD;
&#xD;
               -  History of neurological disease&#xD;
&#xD;
               -  History of cardiovascular disease (or other chronic diseases)&#xD;
&#xD;
               -  Pregnant, planning to become pregnant, or breastfeeding&#xD;
&#xD;
               -  Adherence to special restrained diets (e.g., low-carbohydrate, low-fat, or&#xD;
                  vegetarian/vegan diets) over the last 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pennington Biomedical Research Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808-4124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <results_first_submitted>July 1, 2021</results_first_submitted>
  <results_first_submitted_qc>August 21, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 17, 2021</results_first_posted>
  <last_update_submitted>August 21, 2021</last_update_submitted>
  <last_update_submitted_qc>August 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pennington Biomedical Research Center</investigator_affiliation>
    <investigator_full_name>David McDougal</investigator_full_name>
    <investigator_title>Assistant Professor-Research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 29, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03839641/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>High-fat Meal, Washout (5-7 Days), and Low-fat Meal</title>
          <description>Arm 1 participants randomized to receive high fat meal first, and low fat meal second&#xD;
High fat meal: 60% fat meal&#xD;
Low fat meal: 20% fat meal</description>
        </group>
        <group group_id="P2">
          <title>Low-fat Meal, Washout (5-7 Days), and High-fat Meal</title>
          <description>Arm 2 participants randomized to receive low fat meal first, and high fat meal second&#xD;
High fat meal: 60% fat meal&#xD;
Low fat meal: 20% fat meal</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>High-fat Meal, Washout (5-7 Days), and Low-fat Meal</title>
          <description>Arm 1 participants randomized to receive high fat meal first, and low fat meal second&#xD;
High fat meal: 60% fat meal&#xD;
Low fat meal: 20% fat meal</description>
        </group>
        <group group_id="B2">
          <title>Low-fat Meal, Washout (5-7 Days), and High-fat Meal</title>
          <description>Arm 2 participants randomized to receive low fat meal first, and high fat meal second&#xD;
High fat meal: 60% fat meal&#xD;
Low fat meal: 20% fat meal</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="8"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28" spread="7.5"/>
                    <measurement group_id="B2" value="27" spread="5.7"/>
                    <measurement group_id="B3" value="28" spread="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>baseline respiratory exchange ratio</title>
          <description>The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.845" spread="0.018"/>
                    <measurement group_id="B2" value="0.856" spread="0.026"/>
                    <measurement group_id="B3" value="0.851" spread="0.023"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overnight Respiratory Exchange Ratio</title>
        <description>12-h mean of respiratory exchange ratio following each meal type.&#xD;
measurement interval = 12h following start of meal (7pm)&#xD;
The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.</description>
        <time_frame>12 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High Fat Meal</title>
            <description>overnight respiratory exchange ratio following high-fat meal</description>
          </group>
          <group group_id="O2">
            <title>Low-fat Meal</title>
            <description>overnight respiratory exchange ratio following low-fat meal</description>
          </group>
        </group_list>
        <measure>
          <title>Overnight Respiratory Exchange Ratio</title>
          <description>12-h mean of respiratory exchange ratio following each meal type.&#xD;
measurement interval = 12h following start of meal (7pm)&#xD;
The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.832" spread="0.014"/>
                    <measurement group_id="O2" value="0.887" spread="0.017"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sleep Respiratory Exchange Ratio</title>
        <description>mean of respiratory exchange ratio following each meal type during sleep period, 2am-5am., 2am-5am.&#xD;
measurement interval = 3h (2am-5am)&#xD;
The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.</description>
        <time_frame>3 h</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High Fat Meal</title>
            <description>overnight respiratory exchange ratio following high-fat meal</description>
          </group>
          <group group_id="O2">
            <title>Low-fat Meal</title>
            <description>overnight respiratory exchange ratio following low-fat meal</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep Respiratory Exchange Ratio</title>
          <description>mean of respiratory exchange ratio following each meal type during sleep period, 2am-5am., 2am-5am.&#xD;
measurement interval = 3h (2am-5am)&#xD;
The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.820" spread="0.016"/>
                    <measurement group_id="O2" value="0.867" spread="0.034"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Increase in Respiratory Exchange Ratio</title>
        <description>mean of peak increase in respiratory exchange ratio (Peak values - baseline values) following each meal type&#xD;
Peak values were defined as the peak respiratory exchange ratio value measured during the post-meal period, 6pm-10pm.&#xD;
Baseline values were measured 1h prior to meal (5:00-5:45pm)&#xD;
measurement interval of peak values= 4h (6pm-10pm)&#xD;
A larger value in this measurement indicates that more carbohydrate than fats were being oxidized as fuel during the measurement period.</description>
        <time_frame>4 h</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High Fat Meal</title>
            <description>change in respiratory exchange ratio following high-fat meal</description>
          </group>
          <group group_id="O2">
            <title>Low-fat Meal</title>
            <description>change in respiratory exchange ratio following low-fat meal</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Increase in Respiratory Exchange Ratio</title>
          <description>mean of peak increase in respiratory exchange ratio (Peak values - baseline values) following each meal type&#xD;
Peak values were defined as the peak respiratory exchange ratio value measured during the post-meal period, 6pm-10pm.&#xD;
Baseline values were measured 1h prior to meal (5:00-5:45pm)&#xD;
measurement interval of peak values= 4h (6pm-10pm)&#xD;
A larger value in this measurement indicates that more carbohydrate than fats were being oxidized as fuel during the measurement period.</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.057" spread="0.030"/>
                    <measurement group_id="O2" value="0.103" spread="0.025"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Decrease in Respiratory Exchange Ratio</title>
        <description>mean of peak decrease in respiratory exchange ratio (baseline values -nadir values) following each meal type&#xD;
Peak values were defined as the peak respiratory exchange ratio value measured during the post-meal period, 6pm-10pm.&#xD;
Baseline values were measured 1h prior to meal (5:00-5:45pm)&#xD;
measurement interval of nadir values= 12h (6pm-6am)&#xD;
A larger value in this measurement indicates that more fats than carbohydrate were being oxidized as fuel during the measurement period.</description>
        <time_frame>12 h</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High Fat Meal</title>
            <description>change in respiratory exchange ratio following high-fat meal</description>
          </group>
          <group group_id="O2">
            <title>Low-fat Meal</title>
            <description>change in respiratory exchange ratio following low-fat meal</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Decrease in Respiratory Exchange Ratio</title>
          <description>mean of peak decrease in respiratory exchange ratio (baseline values -nadir values) following each meal type&#xD;
Peak values were defined as the peak respiratory exchange ratio value measured during the post-meal period, 6pm-10pm.&#xD;
Baseline values were measured 1h prior to meal (5:00-5:45pm)&#xD;
measurement interval of nadir values= 12h (6pm-6am)&#xD;
A larger value in this measurement indicates that more fats than carbohydrate were being oxidized as fuel during the measurement period.</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.093" spread="0.031"/>
                    <measurement group_id="O2" value="0.025" spread="0.038"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Peak Respiratory Exchange Ratio</title>
        <description>Average time from meal to peak respiratory exchange ratio value&#xD;
This measurement indicates how long on average it took form the onset of the meal, 6pm, for the participants to achieve their highest/peak respiratory exchange ratio value.</description>
        <time_frame>12 h</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High Fat Meal</title>
            <description>change in respiratory exchange ratio following high-fat meal</description>
          </group>
          <group group_id="O2">
            <title>Low-fat Meal</title>
            <description>change in respiratory exchange ratio following low-fat meal</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Peak Respiratory Exchange Ratio</title>
          <description>Average time from meal to peak respiratory exchange ratio value&#xD;
This measurement indicates how long on average it took form the onset of the meal, 6pm, for the participants to achieve their highest/peak respiratory exchange ratio value.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.9" spread="13.3"/>
                    <measurement group_id="O2" value="100.3" spread="45.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Nadir Respiratory Exchange Ratio</title>
        <description>Average time from meal to nadir respiratory exchange ratio value&#xD;
This measurement indicates how long on average it took form the onset of the meal, 6pm, for the participants to achieve their lowest/nadir respiratory exchange ratio value.</description>
        <time_frame>12 h</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High Fat Meal</title>
            <description>change in respiratory exchange ratio following high-fat meal</description>
          </group>
          <group group_id="O2">
            <title>Low-fat Meal</title>
            <description>change in respiratory exchange ratio following low-fat meal</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Nadir Respiratory Exchange Ratio</title>
          <description>Average time from meal to nadir respiratory exchange ratio value&#xD;
This measurement indicates how long on average it took form the onset of the meal, 6pm, for the participants to achieve their lowest/nadir respiratory exchange ratio value.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="274" spread="12.8"/>
                    <measurement group_id="O2" value="427" spread="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Slope of Respiratory Exchange Ratio</title>
        <description>This value indicates the speed and magnitude of the participants change in respiratory exchange ratio between the peak and nadir values.&#xD;
A more negative value in this measurement indicates either a short time interval between the highest and lowest respiratory exchange ratio values measured and/or a large difference between the highest and lowest values of respiratory exchange ratio values measured.</description>
        <time_frame>12 h</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High Fat Meal</title>
            <description>change in respiratory exchange ratio following high-fat meal</description>
          </group>
          <group group_id="O2">
            <title>Low-fat Meal</title>
            <description>change in respiratory exchange ratio following low-fat meal</description>
          </group>
        </group_list>
        <measure>
          <title>Slope of Respiratory Exchange Ratio</title>
          <description>This value indicates the speed and magnitude of the participants change in respiratory exchange ratio between the peak and nadir values.&#xD;
A more negative value in this measurement indicates either a short time interval between the highest and lowest respiratory exchange ratio values measured and/or a large difference between the highest and lowest values of respiratory exchange ratio values measured.</description>
          <units>ratio/minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.042" spread="0.007"/>
                    <measurement group_id="O2" value="-0.028" spread="0.016"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From enrollment through study completion, an average of 20 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>High-fat Meal</title>
          <description>High fat meal: 60% fat meal</description>
        </group>
        <group group_id="E2">
          <title>Low-fat Meal</title>
          <description>Low fat meal: 20% fat meal</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>muscle ache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>menstrual cramps</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>sinus congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>sore throat</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. David McDougal</name_or_title>
      <organization>Pennington Biomedical Research Center</organization>
      <phone>2257630278</phone>
      <email>DAVID.MCDOUGAL@PBRC.EDU</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03839641
org study id: PBRC 2018-029
nct id: NCT03839641
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overarching aim of this study: To determine the effect of different meal compositions
      (high- vs. low-fat) on metabolic flexibility as it relates to meal-stimulated change in
      respiratory quotient (ΔRQ1) and sleep (ΔRQ2) metabolic flexibility, as well as the time
      course changes in respiratory quotient, RQ (i.e., peak RQ, time to peak RQ, nadir RQ, time to
      nadir, slope).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Investigator, Outcomes Assessor)
measure: Overnight Respiratory Exchange Ratio
time frame: 12 hours
description: 12-h mean of respiratory exchange ratio following each meal type.
measurement interval = 12h following start of meal (7pm)
The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.
measure: Sleep Respiratory Exchange Ratio
time frame: 3 h
description: mean of respiratory exchange ratio following each meal type during sleep period, 2am-5am., 2am-5am.
measurement interval = 3h (2am-5am)
The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.
measure: Peak Increase in Respiratory Exchange Ratio
time frame: 4 h
description: mean of peak increase in respiratory exchange ratio (Peak values - baseline values) following each meal type
Peak values were defined as the peak respiratory exchange ratio value measured during the post-meal period, 6pm-10pm.
Baseline values were measured 1h prior to meal (5:00-5:45pm)
measurement interval of peak values= 4h (6pm-10pm)
A larger value in this measurement indicates that more carbohydrate than fats were being oxidized as fuel during the measurement period.
measure: Peak Decrease in Respiratory Exchange Ratio
time frame: 12 h
description: mean of peak decrease in respiratory exchange ratio (baseline values -nadir values) following each meal type
Peak values were defined as the peak respiratory exchange ratio value measured during the post-meal period, 6pm-10pm.
Baseline values were measured 1h prior to meal (5:00-5:45pm)
measurement interval of nadir values= 12h (6pm-6am)
A larger value in this measurement indicates that more fats than carbohydrate were being oxidized as fuel during the measurement period.
measure: Time to Peak Respiratory Exchange Ratio
time frame: 12 h
description: Average time from meal to peak respiratory exchange ratio value
This measurement indicates how long on average it took form the onset of the meal, 6pm, for the participants to achieve their highest/peak respiratory exchange ratio value.
measure: Time to Nadir Respiratory Exchange Ratio
time frame: 12 h
description: Average time from meal to nadir respiratory exchange ratio value
This measurement indicates how long on average it took form the onset of the meal, 6pm, for the participants to achieve their lowest/nadir respiratory exchange ratio value.
measure: Slope of Respiratory Exchange Ratio
time frame: 12 h
description: This value indicates the speed and magnitude of the participants change in respiratory exchange ratio between the peak and nadir values.
A more negative value in this measurement indicates either a short time interval between the highest and lowest respiratory exchange ratio values measured and/or a large difference between the highest and lowest values of respiratory exchange ratio values measured.
arm group label: High Fat Meal First
arm group type: Experimental
description: Arm 1 participants randomized to receive high fat meal first, and low fat meal second
arm group label: High Fat Meal Second
arm group type: Experimental
description: Arm 2 participants randomized to receive low fat meal first, and high fat meal second
intervention type: Other
intervention name: High fat meal
description: 60% fat meal
arm group label: High Fat Meal First
arm group label: High Fat Meal Second
intervention type: Other
intervention name: Low fat meal
description: 20% fat meal
arm group label: High Fat Meal First
arm group label: High Fat Meal Second
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: David McDougal
investigator title: Assistant Professor-Research
mesh term: Diabetes Mellitus, Type 2
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 