<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/NCT04484987</url>
  </required_header>
  <id_info>
    <org_study_id>1521859</org_study_id>
    <nct_id>NCT04484987</nct_id>
  </id_info>
  <brief_title>The Effect of Time-Restricted Eating in Cardiometabolic Health</brief_title>
  <official_title>The Effect of Time-Restricted Eating in Cardiometabolic Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Time-restricted eating (TRE) is a dietary manipulation that involves restricting food intake&#xD;
      to 6-12 h/day with no energy intake the rest of the day. In rodents, TRE improves metabolic&#xD;
      function without caloric restriction, potentially by activating nutrient sensing mechanisms&#xD;
      and effects on circadian oscillations. However, an understanding of the effect of TRE on&#xD;
      cardiometabolic health in people is not clear and few studies have evaluated this issue.&#xD;
      Accordingly, the investigators propose to conduct a randomized controlled trial in people&#xD;
      with obesity and prediabetes to determine the effect of 9 h TRE for 12 weeks, without a&#xD;
      change in body weight, on key metabolic outcomes that are risk factors for cardiovascular&#xD;
      disease (CVD): 1) multi-organ insulin sensitivity; 2) 24 h metabolic homeostasis and diurnal&#xD;
      rhythm; and 3) adipose tissue and skeletal muscle biology. The proposed studies will&#xD;
      elucidate the cardiometabolic implications of TRE in people with obesity and prediabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 20, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 20, 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>
    <intervention_model_description>Participants will be randomly assigned to one of two diet interventions: TRE group (eating all their food for the day in 9 hours) or the control group (eating all their food for the day in 15 hours) for 12 weeks. Tests to asses changes in metabolism will be performed before and after the intervention.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insulin sensitivity</measure>
    <time_frame>3 months (pre-post intervention)</time_frame>
    <description>Insulin sensitivity will be assessed by using a hyperinsulinemic euglycemic clamp procedure in conjunction with infusion of stable isotope tracers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>24 h glycemic control</measure>
    <time_frame>3 months (pre-post intervention)</time_frame>
    <description>Changes in plasma glucose concentration will be assessed during a 24 h feeding study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adipose tissue gene expression</measure>
    <time_frame>3 months (pre-post intervention)</time_frame>
    <description>Changes in the expression of genes involved in energy metabolism will be assessed by using qPCR.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peripheral diurnal rhythmicity in in peripheral mononuclear blood cells</measure>
    <time_frame>3 months (pre-post intervention)</time_frame>
    <description>We will evaluate changes in clock gene expression</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Obesity</condition>
  <condition>Pre-diabetes</condition>
  <arm_group>
    <arm_group_label>TRE group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Time-restricted eating group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Time-unrestricted eating group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>9 hours daily eating window</intervention_name>
    <description>Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks.</description>
    <arm_group_label>TRE group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>15 hours daily eating window</intervention_name>
    <description>Participants assigned to the control group will have to consume all their daily meals and snacks during a 15-hour window for 12 weeks.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  body mass index 30-39.9 kg/m2&#xD;
&#xD;
          -  fasting plasma glucose 100-125 mg/dl, or 2h OGTT plasma glucose 140-199 mg/dl or&#xD;
             hemoglobin A1C 5.7-6.4%&#xD;
&#xD;
          -  self-reported habitual eating period &gt; 15 h per day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  shift worker, recent or expected travel crossing time zones&#xD;
&#xD;
          -  fasting &gt;12 h/day more than once a week or vegan&#xD;
&#xD;
          -  shift worker, recent or expected travel crossing time zones&#xD;
&#xD;
          -  fasting &gt;12 h/day more than once a week or vegan&#xD;
&#xD;
          -  &gt; once a week no food intake after 1800 h&#xD;
&#xD;
          -  habitually waking up before 0400 h and sleeping before 2230 h&#xD;
&#xD;
          -  ≥ 150 min per week of structured exercise&#xD;
&#xD;
          -  unstable weight (&gt;5% change the last 2 months)&#xD;
&#xD;
          -  type 2 diabetes or other major chronic disease&#xD;
&#xD;
          -  sleep disorder&#xD;
&#xD;
          -  cancer in last 5 years&#xD;
&#xD;
          -  conditions that render subject unable to complete all testing procedures&#xD;
&#xD;
          -  use of medications that affect the study outcome measures or increase the risk of&#xD;
             study procedures and that cannot be temporarily discontinued (e.g., steroids, alpha or&#xD;
             beta adrenergic blockers or agonists, etc.)&#xD;
&#xD;
          -  smoking and illegal drug use&#xD;
&#xD;
          -  pregnant or lactating&#xD;
&#xD;
          -  menopause&#xD;
&#xD;
          -  individuals that have performed procedures involving substantial exposure to radiation&#xD;
             in the last 12 months&#xD;
&#xD;
          -  gastrointestinal or bariatric surgery&#xD;
&#xD;
          -  unable to grant voluntary informed consent or comply with the study instructions&#xD;
&#xD;
          -  individuals who are not yet adults (infants, children, teenagers)&#xD;
&#xD;
          -  prisoners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Maria Chondronikola, PhD</last_name>
    <phone>530-754-1977</phone>
    <email>mchondr@ucdavis.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Romina Sacchi, MS</last_name>
    <phone>5307541766</phone>
    <email>rsacchi@ucdavis.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of California, Davis</name>
      <address>
        <city>Davis</city>
        <state>California</state>
        <zip>95616-5398</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Romina Sacchi, MS</last_name>
      <phone>530-754-1766</phone>
      <email>rsacchi@ucdavis.edu</email>
    </contact>
    <investigator>
      <last_name>Maria Chondronikola, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://studypages.com/s/a-study-of-time-restricted-eating-on-heart-health-metabolism-306499/</url>
    <description>Learn more or sign up for the study here!</description>
  </link>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>June 3, 2022</last_update_submitted>
  <last_update_submitted_qc>June 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chrono-nutrition</keyword>
  <keyword>Adipose tissue</keyword>
  <keyword>Skeletal muscle</keyword>
  <keyword>Insulin sensitivity</keyword>
  <keyword>Diurnal rhythm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prediabetic State</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The final dataset will primarily include data collected specifically for the study, but it will also contain some demographic information and historical data regarding family history of diabetes, obesity, and cardiovascular disease. Upon publication of the primary manuscript, we will consider requests to make the study-related data and relevant demographic information (such as ethnicity) available to other investigators. The final dataset, which will not include subject names, will be further stripped of any other unique identifiers and prepared in accordance with all HIPAA regulations prior to release for sharing. No unique subject characteristics will be included in any reports generated by use of the data.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Upon publication of the study data.</ipd_time_frame>
  </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/NCT04484987
org study id: 1521859
nct id: NCT04484987
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Time-restricted eating (TRE) is a dietary manipulation that involves restricting food intake
      to 6-12 h/day with no energy intake the rest of the day. In rodents, TRE improves metabolic
      function without caloric restriction, potentially by activating nutrient sensing mechanisms
      and effects on circadian oscillations. However, an understanding of the effect of TRE on
      cardiometabolic health in people is not clear and few studies have evaluated this issue.
      Accordingly, the investigators propose to conduct a randomized controlled trial in people
      with obesity and prediabetes to determine the effect of 9 h TRE for 12 weeks, without a
      change in body weight, on key metabolic outcomes that are risk factors for cardiovascular
      disease (CVD): 1) multi-organ insulin sensitivity; 2) 24 h metabolic homeostasis and diurnal
      rhythm; and 3) adipose tissue and skeletal muscle biology. The proposed studies will
      elucidate the cardiometabolic implications of TRE in people with obesity and prediabetes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomly assigned to one of two diet interventions: TRE group (eating all their food for the day in 9 hours) or the control group (eating all their food for the day in 15 hours) for 12 weeks. Tests to asses changes in metabolism will be performed before and after the intervention.
primary purpose: Prevention
masking: None (Open Label)
measure: Insulin sensitivity
time frame: 3 months (pre-post intervention)
description: Insulin sensitivity will be assessed by using a hyperinsulinemic euglycemic clamp procedure in conjunction with infusion of stable isotope tracers.
measure: 24 h glycemic control
time frame: 3 months (pre-post intervention)
description: Changes in plasma glucose concentration will be assessed during a 24 h feeding study.
measure: Adipose tissue gene expression
time frame: 3 months (pre-post intervention)
description: Changes in the expression of genes involved in energy metabolism will be assessed by using qPCR.
measure: Peripheral diurnal rhythmicity in in peripheral mononuclear blood cells
time frame: 3 months (pre-post intervention)
description: We will evaluate changes in clock gene expression
arm group label: TRE group
arm group type: Other
description: Time-restricted eating group
arm group label: Control group
arm group type: Other
description: Time-unrestricted eating group
intervention type: Other
intervention name: 9 hours daily eating window
description: Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks.
arm group label: TRE group
intervention type: Other
intervention name: 15 hours daily eating window
description: Participants assigned to the control group will have to consume all their daily meals and snacks during a 15-hour window for 12 weeks.
arm group label: Control group
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: No
last name: Maria Chondronikola, PhD
phone: 530-754-1977
email: mchondr@ucdavis.edu
last name: Romina Sacchi, MS
phone: 5307541766
email: rsacchi@ucdavis.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: https://studypages.com/s/a-study-of-time-restricted-eating-on-heart-health-metabolism-306499/
description: Learn more or sign up for the study here!
responsible party type: Sponsor
mesh term: Prediabetic State
sharing ipd: Yes
ipd description: The final dataset will primarily include data collected specifically for the study, but it will also contain some demographic information and historical data regarding family history of diabetes, obesity, and cardiovascular disease. Upon publication of the primary manuscript, we will consider requests to make the study-related data and relevant demographic information (such as ethnicity) available to other investigators. The final dataset, which will not include subject names, will be further stripped of any other unique identifiers and prepared in accordance with all HIPAA regulations prior to release for sharing. No unique subject characteristics will be included in any reports generated by use of the data.
ipd info type: Study Protocol
ipd time frame: Upon publication of the study data.