<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/NCT01674049</url>
  </required_header>
  <id_info>
    <org_study_id>081025</org_study_id>
    <nct_id>NCT01674049</nct_id>
  </id_info>
  <brief_title>Nutrient Timing Following Resistance Exercise</brief_title>
  <official_title>Nutrient Timing Following Resistance Exercise in Young Overweight and Obese Young Men With a Family History of Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>George Washington University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Agriculture (USDA)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>George Washington University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the proposed study is to examine the timing of post-exercise feeding on 15&#xD;
      hours post-exercise glycemic control and metabolic flexibility and in overweight and obese&#xD;
      young men with a family history of type 2 diabetes.&#xD;
&#xD;
      Aim 1 - To determine the temporal effects of post-exercise feeding (i.e., immediate&#xD;
      post-exercise vs. 3 hours post-exercise) on glycemic control, peripheral insulin sensitivity,&#xD;
      and metabolic flexibility (as evaluated by sleep RQ) in this same group of participants. We&#xD;
      hypothesize that a 3 hour delay in nutrient ingestion will promote significantly greater&#xD;
      improvements in glucose tolerance, metabolic flexibility, and peripheral insulin sensitivity&#xD;
      both immediately and several hours post-ingestion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study is cross-sectional and utilizes a within-subject design to study young men&#xD;
      under two different nutrient timing protocols, which are randomly-ordered and spaced at least&#xD;
      2 weeks apart.&#xD;
&#xD;
        1. Participants will be screened for eligibility via phone or email and scheduled for an&#xD;
           initial visit, in order to consent to the study and undergo some basic baseline&#xD;
           evaluations. We will rely on participant self-report to verify absence of chronic&#xD;
           disease or drug use.&#xD;
&#xD;
        2. After consenting to the study, fasting blood glucose, height, weight, and air&#xD;
           displacement plethysmography (BodPod®) will be conducted in the Clinical Exercise&#xD;
           Physiology Laboratory at The George Washington University, in Washington, DC. These&#xD;
           measures may occur on the same day as consent or at another scheduled time.&#xD;
&#xD;
        3. After screening, consenting, and baseline assessments, participants will undergo 2&#xD;
           experimental conditions, which will be randomly-ordered and approximately 2 weeks apart.&#xD;
           If possible, both of these experimental visits will be scheduled shortly after the&#xD;
           consent form is signed.&#xD;
&#xD;
        4. A registered dietitian will instruct participants to eat a standardized (35 kcal∙kg body&#xD;
           weight-1∙day-1) diet comprising 60% carbohydrate, 20% protein, and 20% fat for 3 days&#xD;
           prior to both experimental sessions. This instruction will be administered after the&#xD;
           BodPod® assessment is completed.&#xD;
&#xD;
        5. Participants will report to the USDA Laboratory chamber at 7:30 AM for the experimental&#xD;
           sessions. Height, weight blood pressure and heart rate will be measured, then a fasting&#xD;
           blood sample (5 cc) will be obtained for determination of basal glucose &amp; insulin&#xD;
           concentrations. A Hidalgo Ambulatory Monitoring Sensor Array Vest (Equivital I: Hidalgo&#xD;
           Ltd., Cambridge UK) will be worn by all participants measured in the calorimeter for the&#xD;
           entire 48 period. This device measures heart rate (HR), heat flux, core body&#xD;
           temperature, posture and physical activity (PA) from a built-in accelerometer.&#xD;
&#xD;
        6. Then, the sensor portion of the CGMS then will be placed subcutaneously and the CGMS&#xD;
           calibrated with whole blood using the Accu-Check Advantage (Roche Diagnostics,&#xD;
           Indianapolis, IL) glucometer. Participants will then enter the whole room calorimeter&#xD;
           (metabolic chamber) and complete a hunger scale. Hunger will be evaluated 10-20 minutes&#xD;
           before the start of each meal and 2 hours after the resistance exercise bout. On the&#xD;
           first day, participants eat a standard breakfast provided by the USDA kitchen at&#xD;
           approximately 7:45-8:00AM.&#xD;
&#xD;
        7. Gutierrez or a research assistant will take obtain glucometer readings before and 60&#xD;
           minutes after each meal to calibrate the the CGMS. These evaluations will occur 4-6&#xD;
           times over the course of the day.&#xD;
&#xD;
        8. Standardized meals (lunch at 11:00AM and dinner at 7:00PM) will be provided for subjects&#xD;
           by the USDA. Blood samples (5 cc each) will be collected prior to and 120 minutes after&#xD;
           breakfast and lunch; and prior to and 30-, 60-, 90-, and 120-min following the start of&#xD;
           the evening meal for the determination of post-meal responses in glucose &amp; insulin. A&#xD;
           trained phlebotomist with at least 50 successful IV catheter placements will place an IV&#xD;
           catheter into the participant's median antecubital vein before the evening meal to&#xD;
           facilitate multiple draws after the meal.&#xD;
&#xD;
        9. On the second day, subjects will awake in the calorimeter at approximately 7:00 AM and a&#xD;
           fasting blood sample (5 cc) will be obtained for determination of basal concentrations&#xD;
           of glucose &amp; insulin.&#xD;
&#xD;
       10. At about 7:30 AM, subjects will eat a standardized breakfast to be consumed by 8:00 AM.&#xD;
           Two hours after a standardized lunch meal, served at 11:00AM, participants will perform&#xD;
           one of the following resistance exercise nutrient-timing protocols: immediate&#xD;
           post-exercise nutrition at approximately 2:00 PM 3 hour post exercise nutrition at&#xD;
           approximately 5:00 PM). All participants will undergo both experimental conditions at&#xD;
           different testing sessions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">May 2011</completion_date>
  <primary_completion_date type="Actual">May 2011</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Glucose</measure>
    <time_frame>48 hours</time_frame>
    <description>Continuous Glucose Monitoring was used for about 48 hours, from the time the participants entered the chamber on the control day through their release two days later</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum insulin</measure>
    <time_frame>2 hours post supplement ingestion</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Exercise and Immediate Nutrition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40 min of circuit-style resistance exercise and 600g low-fat chocolate milk immediately after the exercise bout</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise and Nutrition 3 hours Post-Bout</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>40 min of circuit-style resistance exercise and 600g low-fat chocolate milk three hours after the exercise bout</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Immediate Nutrition</intervention_name>
    <description>Nutritional supplement consumed either immediately following a 40min resistance exercise bout</description>
    <arm_group_label>Exercise and Immediate Nutrition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nutrition 3 hours Post-Bout</intervention_name>
    <description>Nutritional supplement (600g low-fat chocolate milk) consumed three hours after the exercise bout</description>
    <arm_group_label>Exercise and Nutrition 3 hours Post-Bout</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resistance Exercise</intervention_name>
    <description>A single 40 minute circuit-style bout of resistance exercise</description>
    <arm_group_label>Exercise and Immediate Nutrition</arm_group_label>
    <arm_group_label>Exercise and Nutrition 3 hours Post-Bout</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI= 18-30&#xD;
&#xD;
          -  Report at least one first degree relative with family history of type 2 diabetes -&#xD;
             Healthy with no self-report of diagnosis of chronic disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Self-report prior diagnosis of cardiovascular disease, pulmonary disease, adult&#xD;
             asthma, dyspnea on exertion, current bronchitis, pneumonia, or tuberculosis, vascular&#xD;
             disease, any intercurrent infection, hematologic/oncologic, any metastatic malignancy,&#xD;
             anemia (hematocrit &lt;35), thrombocytopenia, neutropenia, hematologic malignancy,&#xD;
             bleeding dyscrasias, neurologic disorder, endocrine disorder, chronic renal diseases&#xD;
&#xD;
          -  Any illegal drug use&#xD;
&#xD;
          -  Coumadin, heparin, beta blocker, growth hormone supplementation, or illegal drug use&#xD;
&#xD;
          -  Skeletal-muscular injury in the last 6 months (including severe sprains, broken bones,&#xD;
             and tendon or ligament injuries)&#xD;
&#xD;
          -  Alcohol use in excess of 2 drinks per day&#xD;
&#xD;
          -  Smokers&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean L Gutierrez, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The George Washington University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The George Washington University</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>August 28, 2012</last_update_submitted>
  <last_update_submitted_qc>August 28, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>nutrition</keyword>
  <keyword>nutrient</keyword>
  <keyword>timing</keyword>
  <keyword>diabetes</keyword>
  <keyword>family history</keyword>
  <keyword>dairy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</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/NCT01674049
org study id: 081025
nct id: NCT01674049
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of the proposed study is to examine the timing of post-exercise feeding on 15
      hours post-exercise glycemic control and metabolic flexibility and in overweight and obese
      young men with a family history of type 2 diabetes.

      Aim 1 - To determine the temporal effects of post-exercise feeding (i.e., immediate
      post-exercise vs. 3 hours post-exercise) on glycemic control, peripheral insulin sensitivity,
      and metabolic flexibility (as evaluated by sleep RQ) in this same group of participants. We
      hypothesize that a 3 hour delay in nutrient ingestion will promote significantly greater
      improvements in glucose tolerance, metabolic flexibility, and peripheral insulin sensitivity
      both immediately and several hours post-ingestion.
The proposed study is cross-sectional and utilizes a within-subject design to study young men
      under two different nutrient timing protocols, which are randomly-ordered and spaced at least
      2 weeks apart.

        1. Participants will be screened for eligibility via phone or email and scheduled for an
           initial visit, in order to consent to the study and undergo some basic baseline
           evaluations. We will rely on participant self-report to verify absence of chronic
           disease or drug use.

        2. After consenting to the study, fasting blood glucose, height, weight, and air
           displacement plethysmography (BodPod®) will be conducted in the Clinical Exercise
           Physiology Laboratory at The George Washington University, in Washington, DC. These
           measures may occur on the same day as consent or at another scheduled time.

        3. After screening, consenting, and baseline assessments, participants will undergo 2
           experimental conditions, which will be randomly-ordered and approximately 2 weeks apart.
           If possible, both of these experimental visits will be scheduled shortly after the
           consent form is signed.

        4. A registered dietitian will instruct participants to eat a standardized (35 kcal∙kg body
           weight-1∙day-1) diet comprising 60% carbohydrate, 20% protein, and 20% fat for 3 days
           prior to both experimental sessions. This instruction will be administered after the
           BodPod® assessment is completed.

        5. Participants will report to the USDA Laboratory chamber at 7:30 AM for the experimental
           sessions. Height, weight blood pressure and heart rate will be measured, then a fasting
           blood sample (5 cc) will be obtained for determination of basal glucose & insulin
           concentrations. A Hidalgo Ambulatory Monitoring Sensor Array Vest (Equivital I: Hidalgo
           Ltd., Cambridge UK) will be worn by all participants measured in the calorimeter for the
           entire 48 period. This device measures heart rate (HR), heat flux, core body
           temperature, posture and physical activity (PA) from a built-in accelerometer.

        6. Then, the sensor portion of the CGMS then will be placed subcutaneously and the CGMS
           calibrated with whole blood using the Accu-Check Advantage (Roche Diagnostics,
           Indianapolis, IL) glucometer. Participants will then enter the whole room calorimeter
           (metabolic chamber) and complete a hunger scale. Hunger will be evaluated 10-20 minutes
           before the start of each meal and 2 hours after the resistance exercise bout. On the
           first day, participants eat a standard breakfast provided by the USDA kitchen at
           approximately 7:45-8:00AM.

        7. Gutierrez or a research assistant will take obtain glucometer readings before and 60
           minutes after each meal to calibrate the the CGMS. These evaluations will occur 4-6
           times over the course of the day.

        8. Standardized meals (lunch at 11:00AM and dinner at 7:00PM) will be provided for subjects
           by the USDA. Blood samples (5 cc each) will be collected prior to and 120 minutes after
           breakfast and lunch; and prior to and 30-, 60-, 90-, and 120-min following the start of
           the evening meal for the determination of post-meal responses in glucose & insulin. A
           trained phlebotomist with at least 50 successful IV catheter placements will place an IV
           catheter into the participant's median antecubital vein before the evening meal to
           facilitate multiple draws after the meal.

        9. On the second day, subjects will awake in the calorimeter at approximately 7:00 AM and a
           fasting blood sample (5 cc) will be obtained for determination of basal concentrations
           of glucose & insulin.

       10. At about 7:30 AM, subjects will eat a standardized breakfast to be consumed by 8:00 AM.
           Two hours after a standardized lunch meal, served at 11:00AM, participants will perform
           one of the following resistance exercise nutrient-timing protocols: immediate
           post-exercise nutrition at approximately 2:00 PM 3 hour post exercise nutrition at
           approximately 5:00 PM). All participants will undergo both experimental conditions at
           different testing sessions.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Blood Glucose
time frame: 48 hours
description: Continuous Glucose Monitoring was used for about 48 hours, from the time the participants entered the chamber on the control day through their release two days later
measure: Serum insulin
time frame: 2 hours post supplement ingestion
arm group label: Exercise and Immediate Nutrition
arm group type: Experimental
description: 40 min of circuit-style resistance exercise and 600g low-fat chocolate milk immediately after the exercise bout
arm group label: Exercise and Nutrition 3 hours Post-Bout
arm group type: Active Comparator
description: 40 min of circuit-style resistance exercise and 600g low-fat chocolate milk three hours after the exercise bout
intervention type: Dietary Supplement
intervention name: Immediate Nutrition
description: Nutritional supplement consumed either immediately following a 40min resistance exercise bout
arm group label: Exercise and Immediate Nutrition
intervention type: Dietary Supplement
intervention name: Nutrition 3 hours Post-Bout
description: Nutritional supplement (600g low-fat chocolate milk) consumed three hours after the exercise bout
arm group label: Exercise and Nutrition 3 hours Post-Bout
intervention type: Other
intervention name: Resistance Exercise
description: A single 40 minute circuit-style bout of resistance exercise
arm group label: Exercise and Immediate Nutrition
arm group label: Exercise and Nutrition 3 hours Post-Bout
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jean L Gutierrez, PhD
role: Principal Investigator
affiliation: The George Washington University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus