<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/NCT02970188</url>
  </required_header>
  <id_info>
    <org_study_id>15-0108</org_study_id>
    <nct_id>NCT02970188</nct_id>
  </id_info>
  <brief_title>The Effect of Time-restricted Feeding on Physiological Function in Middle-aged and Older Adults</brief_title>
  <official_title>The Effect of Time-restricted Feeding on Physiological Function in Middle-aged and Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Boulder</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Colorado State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Boulder</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and efficacy of time-restricted feeding&#xD;
      (eating within an 8-hour window) for improving physiological function (vascular, motor,&#xD;
      cognitive and metabolic function) in healthy middle-aged and older adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overall, the proposed research project has the long-term potential to influence clinical&#xD;
      practice by establishing novel therapies for treating multiple domains of age-associated&#xD;
      physiological dysfunction and thereby reducing the risk of clinical disease and disability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>April 2016</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Actual">January 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Endothelium Dependent Dilation</measure>
    <time_frame>6 weeks</time_frame>
    <description>Brachial Artery Flow-Mediated Dilation (FMD)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Arterial Stiffness</measure>
    <time_frame>6 weeks</time_frame>
    <description>Aortic Pulse Wave Velocity (PWV)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Function</measure>
    <time_frame>6 weeks</time_frame>
    <description>NIH Toolbox Cognitive Function Battery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor Function</measure>
    <time_frame>6 weeks</time_frame>
    <description>NIH Toolbox Motor Function Battery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic Function</measure>
    <time_frame>6 weeks</time_frame>
    <description>Oral glucose tolerance test (OGTT)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Normal Feeding</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects will be instructed to eat within their normal feeding window.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Time Restricted Feeding</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be instructed to eat with an 8 hour feeding window, starting between 10:30-11:30 AM and stopping between 5:30-6:30 PM.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Time Restricted Feeding</intervention_name>
    <description>consuming all daily calories within an 8 hour feeding window</description>
    <arm_group_label>Time Restricted Feeding</arm_group_label>
    <other_name>TRF</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
          -  Baseline brachial flow-mediated dilation (FMD) &lt; 6%Δ (rationale: non-invasive&#xD;
             screening to ensure exclusion of subjects with exceptionally high baseline endothelial&#xD;
             function.&#xD;
&#xD;
          -  Ability to perform motor and cognitive tests (e.g., can rise from a chair, walk for 2&#xD;
             min, climb 10 stairs)&#xD;
&#xD;
          -  Women will be confirmed as postmenopausal (either natural or surgical) based on&#xD;
             cessation of menses for &gt;1 year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ages &lt;55 years or ≥80 years&#xD;
&#xD;
          -  Occupation that requires night-shift work or abnormal hours that would disrupt eating&#xD;
             schedule&#xD;
&#xD;
          -  Dietary habit of regularly skipping meals, already eating within a ~10 hour window, or&#xD;
             any other form of restrictive eating.&#xD;
&#xD;
          -  Unable to adhere to an 8 hour eating window for the length of the study period&#xD;
&#xD;
          -  Participation in regular vigorous aerobic/endurance exercise (&gt;3 vigorous bouts/week)&#xD;
&#xD;
          -  Not weight stable in the prior 3 months (&gt;2 kg weight change).&#xD;
&#xD;
          -  Body mass index (BMI) &gt;40 kg/m^2 (rationale: vascular function measurements can be&#xD;
             inaccurate in severely obese subjects)&#xD;
&#xD;
          -  Current smoking&#xD;
&#xD;
          -  Diagnosis of a chronic clinical disease (e.g., coronary artery/peripheral&#xD;
             artery/cerebrovascular diseases, diabetes, chronic kidney disease requiring dialysis,&#xD;
             neurological disorders or diseases that may affect motor/cognitive functions [multiple&#xD;
             sclerosis, Parkinson's disease, polio, Alzheimer's disease, dementia or other brain&#xD;
             diseases of aging]), except hypertension and hyperlipidemia.&#xD;
&#xD;
          -  Having unstable angina, acute myocardial infarction, coronary angioplasty, or aorto-&#xD;
             coronary bypass surgery as defined by the occurrence of an event, symptom, surgery, or&#xD;
             change in medication and/or dosage within 3 months prior to enrollment.&#xD;
&#xD;
          -  Having thyroid disease that is not controlled by medications or &lt;3 month's use of a&#xD;
             particular medication and/or dosage (rationale: uncontrolled thyroid diseases are&#xD;
             associated with alterations in vascular function).&#xD;
&#xD;
          -  Having past or present alcohol dependence or abuse, as defined by the American&#xD;
             Psychiatry Association, Diagnostic and Statistical Manual of Mental Disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher R Martens, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Boulder</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Integrative Physiology of Aging Laboratory</name>
      <address>
        <city>Boulder</city>
        <state>Colorado</state>
        <zip>80309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>June 12, 2019</last_update_submitted>
  <last_update_submitted_qc>June 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Colorado, Boulder</investigator_affiliation>
    <investigator_full_name>Douglas Seals</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>time restricted feeding</keyword>
  <keyword>endothelial function</keyword>
  <keyword>arterial stiffness</keyword>
  <keyword>intermittent fasting</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02970188
org study id: 15-0108
nct id: NCT02970188
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to assess the safety and efficacy of time-restricted feeding
      (eating within an 8-hour window) for improving physiological function (vascular, motor,
      cognitive and metabolic function) in healthy middle-aged and older adults.
Overall, the proposed research project has the long-term potential to influence clinical
      practice by establishing novel therapies for treating multiple domains of age-associated
      physiological dysfunction and thereby reducing the risk of clinical disease and disability.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Endothelium Dependent Dilation
time frame: 6 weeks
description: Brachial Artery Flow-Mediated Dilation (FMD)
measure: Arterial Stiffness
time frame: 6 weeks
description: Aortic Pulse Wave Velocity (PWV)
measure: Cognitive Function
time frame: 6 weeks
description: NIH Toolbox Cognitive Function Battery
measure: Motor Function
time frame: 6 weeks
description: NIH Toolbox Motor Function Battery
measure: Metabolic Function
time frame: 6 weeks
description: Oral glucose tolerance test (OGTT)
arm group label: Normal Feeding
arm group type: No Intervention
description: Subjects will be instructed to eat within their normal feeding window.
arm group label: Time Restricted Feeding
arm group type: Experimental
description: Subjects will be instructed to eat with an 8 hour feeding window, starting between 10:30-11:30 AM and stopping between 5:30-6:30 PM.
intervention type: Behavioral
intervention name: Time Restricted Feeding
description: consuming all daily calories within an 8 hour feeding window
arm group label: Time Restricted Feeding
other name: TRF
criteria: 
gender: All
minimum age: 55 Years
maximum age: 79 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christopher R Martens, Ph.D.
role: Principal Investigator
affiliation: University of Colorado, Boulder
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Colorado, Boulder
investigator full name: Douglas Seals
investigator title: Professor
sharing ipd: No