<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/NCT02211391</url>
  </required_header>
  <id_info>
    <org_study_id>HSC# 2014.13509</org_study_id>
    <nct_id>NCT02211391</nct_id>
  </id_info>
  <brief_title>Nighttime Protein Intake on Overnight Lipolysis and Morning Fat Oxidation in Obese Men</brief_title>
  <official_title>The Effect of Nighttime Protein Intake on Overnight Lipolysis and Morning Fat Oxidation in Obese Men.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Florida State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Single macronutrients will be consumed before sleep by obese men. Overnight lipolysis will be&#xD;
      measured with the microdialysis technique by measuring glycerol concentration and blood flow&#xD;
      in abdominal adipose tissue. Morning fat oxidation will be measured with indirect&#xD;
      calorimetry.&#xD;
&#xD;
      The investigators hypothesize that carbohydrate intake will blunt the overnight lipolysis&#xD;
      rate compared to casein protein and a non-caloric placebo. The investigators also hypothesize&#xD;
      that casein and placebo will not be significantly different from each other in terms of&#xD;
      overnight lipolysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lipolysis</measure>
    <time_frame>Change from day 1 to day 2 to day 3 of testing</time_frame>
    <description>Measuring lipolysis using the microdialysis technique. Samples will be collected at various time intervals&#xD;
Vial 1: 30 minute; 2.0 uL/min flow rate&#xD;
Vial 2: 4 hours; 0.3 uL/min flow rate&#xD;
Vial 3: Overnight; 0.3 uL/min flow rate (before taking nighttime supplement)&#xD;
Vial 4: Morning sample #1; 2.0 uL/min flow rate (upon waking)&#xD;
Vial 5: Morning sample #2; 2.0 uL/min flow rate (arrive to lab)&#xD;
Blood flow will be measured using the Ethanol technique</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Resting Metabolic Rate (RMR)</measure>
    <time_frame>Change from day 1 to day 2 to day 3</time_frame>
    <description>RMR will be measured with indirect calorimetry using the ventilated hood technique</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Appetite</measure>
    <time_frame>Change from Baseline to day 1, 2, and 3</time_frame>
    <description>Appetite will be measured by visual analog scales</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood hormones</measure>
    <time_frame>Change from Baseline to day 1, 2, and 3</time_frame>
    <description>Hormones related to appetite and metabolism will be examined.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Casein Protein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Casein protein (30g) will be consumed as the last food/caloric beverage and within 30 minute of sleep</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-caloric Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The non-caloric placebo beverage will will be consumed as the last food/caloric beverage and within 30 minute of sleep</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Casein Protein</intervention_name>
    <description>The effect of casein protein consumed within 30 minutes of sleep on overnight lipolysis and next morning metabolism and appetite will be examined</description>
    <arm_group_label>Casein Protein</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-caloric placebo</intervention_name>
    <description>The effect of a non-caloric placebo consumed within 30 minutes of sleep on overnight lipolysis and next morning metabolism and appetite will be examined</description>
    <arm_group_label>Non-caloric Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy, sedentary overweight or obese (BMI ≥25 kg/m^2; body fat ≥ 25% ) men&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Men that have been exercising for more than 2 days per week for more than 45 minutes&#xD;
             per session (within the past 6 months), have uncontrolled hypertension (Blood Pressure&#xD;
             (BP)&gt;160/100 mmHg, diagnosed cardiovascular disease, stroke, diabetes, thyroid or&#xD;
             kidney dysfunction, take cholesterol medication, or have any allergies to milk&#xD;
             products will be excluded. Smokers will also be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael J Ormsbee, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Florida State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Sports Science and Medicine, Florida State University</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>August 10, 2015</last_update_submitted>
  <last_update_submitted_qc>August 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Florida State University</investigator_affiliation>
    <investigator_full_name>Michael J. Ormsbee</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Nighttime Eating</keyword>
  <keyword>Protein</keyword>
  <keyword>Obesity</keyword>
  <keyword>Lipolysis</keyword>
  <keyword>Metabolism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Caseins</mesh_term>
  </intervention_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/NCT02211391
org study id: HSC# 2014.13509
nct id: NCT02211391
lead sponsor: 
has dmc: No
Single macronutrients will be consumed before sleep by obese men. Overnight lipolysis will be
      measured with the microdialysis technique by measuring glycerol concentration and blood flow
      in abdominal adipose tissue. Morning fat oxidation will be measured with indirect
      calorimetry.

      The investigators hypothesize that carbohydrate intake will blunt the overnight lipolysis
      rate compared to casein protein and a non-caloric placebo. The investigators also hypothesize
      that casein and placebo will not be significantly different from each other in terms of
      overnight lipolysis.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Lipolysis
time frame: Change from day 1 to day 2 to day 3 of testing
description: Measuring lipolysis using the microdialysis technique. Samples will be collected at various time intervals
Vial 1: 30 minute; 2.0 uL/min flow rate
Vial 2: 4 hours; 0.3 uL/min flow rate
Vial 3: Overnight; 0.3 uL/min flow rate (before taking nighttime supplement)
Vial 4: Morning sample #1; 2.0 uL/min flow rate (upon waking)
Vial 5: Morning sample #2; 2.0 uL/min flow rate (arrive to lab)
Blood flow will be measured using the Ethanol technique
measure: Resting Metabolic Rate (RMR)
time frame: Change from day 1 to day 2 to day 3
description: RMR will be measured with indirect calorimetry using the ventilated hood technique
measure: Appetite
time frame: Change from Baseline to day 1, 2, and 3
description: Appetite will be measured by visual analog scales
measure: Blood hormones
time frame: Change from Baseline to day 1, 2, and 3
description: Hormones related to appetite and metabolism will be examined.
arm group label: Casein Protein
arm group type: Experimental
description: Casein protein (30g) will be consumed as the last food/caloric beverage and within 30 minute of sleep
arm group label: Non-caloric Placebo
arm group type: Placebo Comparator
description: The non-caloric placebo beverage will will be consumed as the last food/caloric beverage and within 30 minute of sleep
intervention type: Other
intervention name: Casein Protein
description: The effect of casein protein consumed within 30 minutes of sleep on overnight lipolysis and next morning metabolism and appetite will be examined
arm group label: Casein Protein
intervention type: Other
intervention name: Non-caloric placebo
description: The effect of a non-caloric placebo consumed within 30 minutes of sleep on overnight lipolysis and next morning metabolism and appetite will be examined
arm group label: Non-caloric Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael J Ormsbee, PhD
role: Principal Investigator
affiliation: Florida State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Florida State University
investigator full name: Michael J. Ormsbee
investigator title: Assistant Professor
mesh term: Obesity
mesh term: Caseins