xml: <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/NCT05987566</url>
    </required_header>
    <id_info>
      <org_study_id>HM20026660</org_study_id>
      <nct_id>NCT05987566</nct_id>
    </id_info>
    <brief_title>Chronobiology of Meal Timing: Effects on Vascular and Renal Function</brief_title>
    <official_title>Chronobiology of Meal Timing: Effects on Vascular and Renal Function</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Virginia Commonwealth University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Virginia Commonwealth University</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 us to investigate the effects of mistimed eating on blood pressure,&#xD;
        kidney function and vascular function.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Despite advancements in pharmacologic antihypertensives, hypertension currently affects 1 in&#xD;
        3 Americans and accounts for more than $50 billion of health care spending. Importantly,&#xD;
        hypertension is the leading cause of cardiovascular (CVD) and kidney diseases (CKD). As a&#xD;
        result, the AHA/ACC lowered the diagnostic criteria for hypertension to encourage earlier&#xD;
        preventative lifestyle intervention. There is a critical need to identify and implement novel&#xD;
        lifestyle interventions in individuals with early-stage hypertension to prevent the&#xD;
        subsequent development of CVD and CKD. Chronotherapy that aligns behavioral cues (such as&#xD;
        time of eating) with the body's internal biological clocks, has gained much attention as a&#xD;
        potential strategy to prevent and manage hypertension, however, the underlying mechanisms are&#xD;
        not yet fully understood. The purpose of this study is to investigate the effects of mistimed&#xD;
        eating on blood pressure, kidney function and vascular function.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Urinary sodium excretion and markers of kidney injury</measure>
      <time_frame>24 hours</time_frame>
      <description>Day and nocturnal urinary sodium, NGAL and KIM-1</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>24hr ambulatory blood pressure</measure>
      <time_frame>24 Hours</time_frame>
      <description>Day and nocturnal ambulatory blood pressure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Macrovascular function</measure>
      <time_frame>At baseline and after each 24hour experimental arm</time_frame>
      <description>Brachial artery endothelial function assessed by flow mediated dilation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Microvascular function</measure>
      <time_frame>At baseline and after each 24hour experimental arm</time_frame>
      <description>Skin blood flow response to local heating measured by laser doppler flowmetry</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">14</enrollment>
    <condition>Hypertension</condition>
    <arm_group>
      <arm_group_label>Morning Meal Challenge</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Late Night Meal Challenge</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Morning meal challenge</intervention_name>
      <description>A Western-style diet meal which will be individualized for caloric consumption by estimated total daily energy expenditure eaten after 1 hour of waking up in the morning</description>
      <arm_group_label>Morning Meal Challenge</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Evening meal challenge</intervention_name>
      <description>A Western-style diet meal which will be individualized for caloric consumption by estimated total daily energy expenditure eaten within 1 hour of going to bed</description>
      <arm_group_label>Late Night Meal Challenge</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Men and Women aged 18-45 years&#xD;
  &#xD;
            -  Elevated (SBP 120-129; DBP &lt;80 mmHg) or stage 1 hypertension (SBP 130-139; DBP 80-89&#xD;
               mmHg)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of chronic disease (CV, lung, cancer, renal, sleep apnea, diabetes,&#xD;
               autoimmune)&#xD;
  &#xD;
            -  Anti-hypertensive medication use&#xD;
  &#xD;
            -  Currently pregnant or lactating&#xD;
  &#xD;
            -  Current shift worker&#xD;
  &#xD;
            -  Travel &gt;3 time zones four weeks before the start of the study or during the study&#xD;
  &#xD;
            -  Insomnia&#xD;
  &#xD;
            -  Practiced intermittent fasting in past six months&#xD;
  &#xD;
            -  Current nicotine use&#xD;
  &#xD;
            -  Current hormone replacement therapy&#xD;
  &#xD;
            -  Current melatonin use&#xD;
  &#xD;
            -  Current use of antioxidants and unwilling to stop taking them for the duration of the&#xD;
               study&#xD;
  &#xD;
            -  Unable to provide informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Danielle Kirkman</last_name>
      <role>Principal Investigator</role>
      <affiliation>Virginia Commonwealth University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Natalie Bohmke</last_name>
      <phone>(540) 842-9009</phone>
      <email>bohmkenj@vcu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Danielle Kirkman</last_name>
      <phone>dlkirkman@vcu.edu</phone>
      <email>dlkirkman@vcu.edu</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05987566
  org study id: HM20026660
  nct id: NCT05987566
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study us to investigate the effects of mistimed eating on blood pressure,
        kidney function and vascular function.
  Despite advancements in pharmacologic antihypertensives, hypertension currently affects 1 in
        3 Americans and accounts for more than $50 billion of health care spending. Importantly,
        hypertension is the leading cause of cardiovascular (CVD) and kidney diseases (CKD). As a
        result, the AHA/ACC lowered the diagnostic criteria for hypertension to encourage earlier
        preventative lifestyle intervention. There is a critical need to identify and implement novel
        lifestyle interventions in individuals with early-stage hypertension to prevent the
        subsequent development of CVD and CKD. Chronotherapy that aligns behavioral cues (such as
        time of eating) with the body's internal biological clocks, has gained much attention as a
        potential strategy to prevent and manage hypertension, however, the underlying mechanisms are
        not yet fully understood. The purpose of this study is to investigate the effects of mistimed
        eating on blood pressure, kidney function and vascular function.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Urinary sodium excretion and markers of kidney injury
  time frame: 24 hours
  description: Day and nocturnal urinary sodium, NGAL and KIM-1
  measure: 24hr ambulatory blood pressure
  time frame: 24 Hours
  description: Day and nocturnal ambulatory blood pressure
  measure: Macrovascular function
  time frame: At baseline and after each 24hour experimental arm
  description: Brachial artery endothelial function assessed by flow mediated dilation
  measure: Microvascular function
  time frame: At baseline and after each 24hour experimental arm
  description: Skin blood flow response to local heating measured by laser doppler flowmetry
  arm group label: Morning Meal Challenge
  arm group type: Experimental
  arm group label: Late Night Meal Challenge
  arm group type: Experimental
  intervention type: Other
  intervention name: Morning meal challenge
  description: A Western-style diet meal which will be individualized for caloric consumption by estimated total daily energy expenditure eaten after 1 hour of waking up in the morning
  arm group label: Morning Meal Challenge
  intervention type: Other
  intervention name: Evening meal challenge
  description: A Western-style diet meal which will be individualized for caloric consumption by estimated total daily energy expenditure eaten within 1 hour of going to bed
  arm group label: Late Night Meal Challenge
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: No
  last name: Danielle Kirkman
  role: Principal Investigator
  affiliation: Virginia Commonwealth University
  last name: Natalie Bohmke
  phone: (540) 842-9009
  email: bohmkenj@vcu.edu
  last name: Danielle Kirkman
  phone: dlkirkman@vcu.edu
  email: dlkirkman@vcu.edu
  responsible party type: Sponsor
  mesh term: Hypertension
  sharing ipd: No