<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/NCT03000803</url>
  </required_header>
  <id_info>
    <org_study_id>IRB16-1174</org_study_id>
    <nct_id>NCT03000803</nct_id>
  </id_info>
  <brief_title>Circadian Control of Human Circulating Endocannabinoid Levels</brief_title>
  <official_title>Circadian Control of Human Circulating Endocannabinoid Levels</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</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 purpose of this study is to examine how the timing of eating changes how the body makes&#xD;
      and uses energy (metabolism). This study will also examine how fat cells respond to insulin&#xD;
      (a hormone that controls blood sugar levels).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The timing of food intake and caloric distribution across the 24hr day are emerging as&#xD;
      contributing factors to weight gain. The idea that not only what you eat, but when you eat&#xD;
      can contribute to weight gain has garnered interest from both the scientific community and&#xD;
      the public. In fact, the distribution of caloric intake over the 24hr day has been recently&#xD;
      recognized as a potential source of &quot;circadian misalignment&quot; which can result in adverse&#xD;
      health outcomes, including overeating, impaired glucose tolerance and insulin sensitivity.&#xD;
      Moreover, reward driven eating (eating for the pleasurable aspect instead of energy need)&#xD;
      generally results in caloric intake well in excess of energy requirements and is recognized&#xD;
      as a major culprit in the epidemic of obesity. The endocannabinoid (eCB) system is involved&#xD;
      in both homeostatic processes (energy need only) that govern food intake, and has been shown&#xD;
      to play a key role in reward eating. Thus, the role of circadian organization of the eCB&#xD;
      system and how misalignment may contribute to overeating, overweight, obesity, and diabetes&#xD;
      is the main focus of this study. The overall goal is to determine whether the timing of food&#xD;
      intake is a major determinant of the 24 hour variation in eCB activity that in turn affects&#xD;
      hunger and appetite, glucose metabolism, and insulin sensitivity. This study will focus on&#xD;
      overweight individuals who are at high risk of obesity but are still on a trajectory that can&#xD;
      potentially be reversed by lifestyle changes. Following a careful assessment of the subject's&#xD;
      habitual sleep and meal timing and caloric distribution under real life conditions, a short&#xD;
      laboratory study will determine whether participants who consume more of their daily calories&#xD;
      later in the day (later dietary chronotype) display delays in the eCB rhythm and lower&#xD;
      insulin sensitivity. During a 6-day in patient intervention, combining laboratory and&#xD;
      ambulatory procedures, study procedures will assess the effect of experimentally changing&#xD;
      caloric distribution across the day, advancing versus delaying the dietary chronotype. The&#xD;
      outcome measures will be the timing of the daily peak of the eCB rhythm and insulin&#xD;
      sensitivity. This study will also measure the potential durability of the intervention on&#xD;
      subsequent habitual behavior under real life conditions, in that how long does one maintain&#xD;
      the feeding in lab imposed feeding schedule and does that schedule effect subsequent behavior&#xD;
      and/or weight. Identification of circadian misalignment of the eCB system as a mediator of&#xD;
      increased food intake and reduced insulin sensitivity may help develop novel preventive&#xD;
      strategies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">April 2024</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2025</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in timing of peak of endocannabinoid rhythm</measure>
    <time_frame>Day 37</time_frame>
    <description>The change in the timing (hours) of the peak of the endocannabinoid rhythm from baseline to 37 days after the intervention will be measured.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>Day 37</time_frame>
    <description>The change in weight (kilograms) from baseline to 37 days after intervention will be measured.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Early Total Caloric Intake</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Early Total Caloric Intake study group will consume the majority of their daily calories during breakfast.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Late Total Caloric Intake</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Late Total Caloric Intake study group will consume the majority of their daily calories during dinner.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Early Total Caloric Intake</intervention_name>
    <description>Provide subjects a regimented amount of calories at each meal.</description>
    <arm_group_label>Early Total Caloric Intake</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Late Total Caloric Intake</intervention_name>
    <description>Provide subjects a regimented amount of calories at each meal.</description>
    <arm_group_label>Late Total Caloric Intake</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  self-report sleeping between 7-hrs/night and 9-hrs/night, between 22:00 and 08:00&#xD;
&#xD;
          -  self-report having gained at least 3lbs in the last year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no previously diagnosed sleep disorders (including obstructive sleep apnea (OSA))&#xD;
&#xD;
          -  no existing diagnosis of prediabetes or diabetes&#xD;
&#xD;
          -  no history of endocrine dysfunction&#xD;
&#xD;
          -  no history of psychiatric, cardiovascular, or eating disorders&#xD;
&#xD;
          -  must not have a gastro-intestinal disease that requires dietary adjustment&#xD;
&#xD;
          -  currently taking no medications (including birth control)&#xD;
&#xD;
          -  drug and nicotine use, habitual alcohol use of more than 2 drinks per day, and&#xD;
             caffeine intake of more than 300 mg per day&#xD;
&#xD;
          -  anyone who has participated in medically managed weight loss program within the past&#xD;
             year,&#xD;
&#xD;
          -  anyone who has undergone bariatric surgery,&#xD;
&#xD;
          -  must not have dietary restrictions&#xD;
&#xD;
          -  must not work night shifts or crossed any time zones in the month prior to the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erin Hanlon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Erin Hanlon, PhD</last_name>
    <phone>773 834 5849</phone>
    <email>ehanlon@bsd.uchicago.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Matthew Brady, PhD</last_name>
    <phone>(773) 702-2346</phone>
    <email>mbrady@bsd.uchicago.edu</email>
  </overall_contact_backup>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>There is currently no plan to make IPD available to other researchers.</ipd_description>
  </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/NCT03000803
org study id: IRB16-1174
nct id: NCT03000803
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine how the timing of eating changes how the body makes
      and uses energy (metabolism). This study will also examine how fat cells respond to insulin
      (a hormone that controls blood sugar levels).
The timing of food intake and caloric distribution across the 24hr day are emerging as
      contributing factors to weight gain. The idea that not only what you eat, but when you eat
      can contribute to weight gain has garnered interest from both the scientific community and
      the public. In fact, the distribution of caloric intake over the 24hr day has been recently
      recognized as a potential source of "circadian misalignment" which can result in adverse
      health outcomes, including overeating, impaired glucose tolerance and insulin sensitivity.
      Moreover, reward driven eating (eating for the pleasurable aspect instead of energy need)
      generally results in caloric intake well in excess of energy requirements and is recognized
      as a major culprit in the epidemic of obesity. The endocannabinoid (eCB) system is involved
      in both homeostatic processes (energy need only) that govern food intake, and has been shown
      to play a key role in reward eating. Thus, the role of circadian organization of the eCB
      system and how misalignment may contribute to overeating, overweight, obesity, and diabetes
      is the main focus of this study. The overall goal is to determine whether the timing of food
      intake is a major determinant of the 24 hour variation in eCB activity that in turn affects
      hunger and appetite, glucose metabolism, and insulin sensitivity. This study will focus on
      overweight individuals who are at high risk of obesity but are still on a trajectory that can
      potentially be reversed by lifestyle changes. Following a careful assessment of the subject's
      habitual sleep and meal timing and caloric distribution under real life conditions, a short
      laboratory study will determine whether participants who consume more of their daily calories
      later in the day (later dietary chronotype) display delays in the eCB rhythm and lower
      insulin sensitivity. During a 6-day in patient intervention, combining laboratory and
      ambulatory procedures, study procedures will assess the effect of experimentally changing
      caloric distribution across the day, advancing versus delaying the dietary chronotype. The
      outcome measures will be the timing of the daily peak of the eCB rhythm and insulin
      sensitivity. This study will also measure the potential durability of the intervention on
      subsequent habitual behavior under real life conditions, in that how long does one maintain
      the feeding in lab imposed feeding schedule and does that schedule effect subsequent behavior
      and/or weight. Identification of circadian misalignment of the eCB system as a mediator of
      increased food intake and reduced insulin sensitivity may help develop novel preventive
      strategies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in timing of peak of endocannabinoid rhythm
time frame: Day 37
description: The change in the timing (hours) of the peak of the endocannabinoid rhythm from baseline to 37 days after the intervention will be measured.
measure: Weight
time frame: Day 37
description: The change in weight (kilograms) from baseline to 37 days after intervention will be measured.
arm group label: Early Total Caloric Intake
arm group type: Experimental
description: The Early Total Caloric Intake study group will consume the majority of their daily calories during breakfast.
arm group label: Late Total Caloric Intake
arm group type: Active Comparator
description: The Late Total Caloric Intake study group will consume the majority of their daily calories during dinner.
intervention type: Behavioral
intervention name: Early Total Caloric Intake
description: Provide subjects a regimented amount of calories at each meal.
arm group label: Early Total Caloric Intake
intervention type: Behavioral
intervention name: Late Total Caloric Intake
description: Provide subjects a regimented amount of calories at each meal.
arm group label: Late Total Caloric Intake
criteria: 
gender: All
minimum age: 19 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Erin Hanlon, PhD
role: Principal Investigator
affiliation: University of Chicago
last name: Erin Hanlon, PhD
phone: 773 834 5849
email: ehanlon@bsd.uchicago.edu
last name: Matthew Brady, PhD
phone: (773) 702-2346
email: mbrady@bsd.uchicago.edu
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: There is currently no plan to make IPD available to other researchers.