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/NCT06019195</url>
    </required_header>
    <id_info>
      <org_study_id>temp749424</org_study_id>
      <nct_id>NCT06019195</nct_id>
    </id_info>
    <brief_title>The Effect of Intermittent Fasting on Brain Health</brief_title>
    <official_title>Time Restricted Eating for Prevention of Age-related Vascular Cognitive Decline in Older Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Oklahoma</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Oklahoma</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 central hypothesis of this study is that closer adherence to time restricted eating (TRE)&#xD;
        will improve endothelial function, neurovascular (NVC) responses, resulting in improved&#xD;
        cognitive performance, potentially through activation of SIRT1-dependent vasoprotective&#xD;
        pathways.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This hypothesis will be tested by assessing the effect of TRE (not more than 10hr eating&#xD;
        window each day for 6 months) in healthy older adults (55-80 years of age).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in neurovascular coupling using functional near infrared spectroscopy (fNIRS)</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>Functional near infrared spectroscopy (fNIRS) will be performed during the cognitive n-back task. fNIRS approach generates data that represent a relative change in oxygenated and deoxygenated hemoglobin measured over the cortical brain tissues. Neurovascular coupling will be evaluated as a change in oxy- and deoxy-hemoglobin between before and after completion of study.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in neurovascular coupling using the dynamic retinal vessel analysis</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>Flicker light-induced dilation of the retinal vessels (percentage increase over baseline diameter) will be measured in the right or left eye of each study participant using the Dynamic Vessel Analyzer (DVA, IMEDOS Systems, Jena, Germany). The change in retinal vessel diameters is tracked and reported as a %change from baseline, before and after completion of study.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in EEG spectra</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>EEG signal will be collected to generate spectral data. These data will be used for comparison of EEG activity between before and after treatment. Units of measure - power spectral density. Reported as a %change from baseline, before and after completion of study.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in microvascular endothelial function</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>Changes in microvascular endothelial function will be assessed using laser speckle contrast imaging (LSCI) in the hand using the flow mediated dilation approach. The change in skin perfusion is calculated and reported as a %change from baseline, between before and after completion of study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in deep tissue oxygen saturation</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>Transcutaneous deep tissue oxygen saturation will be measured using the inSpectra near infrared device. The data are calculated and reported as a %change from baseline, between before and after completion of study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in arterial stiffness</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>The arterial stiffness will be measured using the pulse wave analysis approach (SphygmoCor, Atcor medical, Itasca IL, or similar). Analysis generated the augmentation index which will be used for comparison before and after completion of study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Glycocalyx - perfused boundary region</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>Video recordings of the sublingual vasculature will be performed using the high definition video camera GlycoCheck (Microvascular health solutions). Data collected will include perfused boundary region (um), and will be used for comparison before and after completion of study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in capillary density</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>Video recordings of the sublingual vasculature will be performed using the high definition video camera GlycoCheck (Microvascular health solutions). Data collected will include capillary density (mm/mm^2), and will be used for comparison before and after completion of study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in red blood cell velocity</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>Video recordings of the sublingual vasculature will be performed using the high definition video camera GlycoCheck (Microvascular health solutions). Data collected will include red blood cell velocity (um/sec), and will be used for comparison before and after treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Attention</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>CANTAB research attention test.Reported as a %change from baseline, before and after completion of study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Working Memory</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>CANTAB research working memory test.Reported as a %change from baseline, before and after completion of study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Executive Function</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>CANTAB research executive function test.Reported as a %change from baseline, before and after completion of study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Processing Speed</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>CANTAB research processing speed test.Reported as a %change from baseline, before and after completion of study</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body composition</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>Weight and body composition using a bioimpedance scale. Reported as a %change from baseline, before and after completion of study</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dietary intakes</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>Dietary intake data for 24-hour recalls will be collected and analyzed using the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool, version 2022, developed by the National Cancer Institute (https://epi.grants.cancer.gov/asa24). Estimated dietary intakes will be used to determine whether a participant was in a hypocaloric, eucaloric, or hypercaloric state during the intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total daily energy expenditure</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>Total daily energy expenditure will be estimated using the Mifflin-St. Jeor equation. Estimated total daily energy expenditure will be used to determine whether a participant was in a hypocaloric, eucaloric, or hypercaloric state during the intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in blood metabolic panel markers</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>Complete metabolic panel. Reported as a %change from baseline, before and after completion of study</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Intermittent Fasting</condition>
    <condition>Aging</condition>
    <arm_group>
      <arm_group_label>Time restricted eating</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>not more than 10 hrs. eating window daily goal for 6 months</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Time restricted eating</intervention_name>
      <description>not more than 10 hrs. eating window daily goal for 6 months</description>
      <arm_group_label>Time restricted eating</arm_group_label>
      <other_name>intermittent fasting</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥55 and ≤80 years of age&#xD;
  &#xD;
            -  Adequate hearing and visual acuity to participate in the examinations&#xD;
  &#xD;
            -  Ability to read and write in English&#xD;
  &#xD;
            -  Competence to provide informed consent.&#xD;
  &#xD;
            -  Mini-Mental State Exam score ≥24&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Vision or hearing impairment that would impair the ability to complete study&#xD;
               assessments&#xD;
  &#xD;
            -  Active CNS disease including multiple sclerosis, uncontrolled seizures, active brain&#xD;
               cancer&#xD;
  &#xD;
            -  Cerebrovascular accident other than TIA within 60 days prior to Visit 0&#xD;
  &#xD;
            -  Major psychiatric disease, including major depression not currently controlled on&#xD;
               medications, alcohol or drug abuse&#xD;
  &#xD;
            -  Diabetics prescribed sulfonylureas, meglitinides, and insulin&#xD;
  &#xD;
            -  Any other medical condition which, in the opinion of investigator, would render the&#xD;
               patient inappropriate or too unstable to complete the study protocol&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Translational GeroScience Laboratory</name>
        <address>
          <city>Oklahoma City</city>
          <state>Oklahoma</state>
          <zip>73117</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 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>
    <keyword>Intermittent Fasting</keyword>
    <keyword>Aging</keyword>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>unidentified data may be shared via research repositories</ipd_description>
    </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/NCT06019195
  org study id: temp749424
  nct id: NCT06019195
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The central hypothesis of this study is that closer adherence to time restricted eating (TRE)
        will improve endothelial function, neurovascular (NVC) responses, resulting in improved
        cognitive performance, potentially through activation of SIRT1-dependent vasoprotective
        pathways.
  This hypothesis will be tested by assessing the effect of TRE (not more than 10hr eating
        window each day for 6 months) in healthy older adults (55-80 years of age).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Change in neurovascular coupling using functional near infrared spectroscopy (fNIRS)
  time frame: baseline, up to 6 months
  description: Functional near infrared spectroscopy (fNIRS) will be performed during the cognitive n-back task. fNIRS approach generates data that represent a relative change in oxygenated and deoxygenated hemoglobin measured over the cortical brain tissues. Neurovascular coupling will be evaluated as a change in oxy- and deoxy-hemoglobin between before and after completion of study.
  measure: Change in neurovascular coupling using the dynamic retinal vessel analysis
  time frame: baseline, up to 6 months
  description: Flicker light-induced dilation of the retinal vessels (percentage increase over baseline diameter) will be measured in the right or left eye of each study participant using the Dynamic Vessel Analyzer (DVA, IMEDOS Systems, Jena, Germany). The change in retinal vessel diameters is tracked and reported as a %change from baseline, before and after completion of study.
  measure: Change in EEG spectra
  time frame: baseline, up to 6 months
  description: EEG signal will be collected to generate spectral data. These data will be used for comparison of EEG activity between before and after treatment. Units of measure - power spectral density. Reported as a %change from baseline, before and after completion of study.
  measure: Change in microvascular endothelial function
  time frame: baseline, up to 6 months
  description: Changes in microvascular endothelial function will be assessed using laser speckle contrast imaging (LSCI) in the hand using the flow mediated dilation approach. The change in skin perfusion is calculated and reported as a %change from baseline, between before and after completion of study.
  measure: Change in deep tissue oxygen saturation
  time frame: baseline, up to 6 months
  description: Transcutaneous deep tissue oxygen saturation will be measured using the inSpectra near infrared device. The data are calculated and reported as a %change from baseline, between before and after completion of study.
  measure: Change in arterial stiffness
  time frame: baseline, up to 6 months
  description: The arterial stiffness will be measured using the pulse wave analysis approach (SphygmoCor, Atcor medical, Itasca IL, or similar). Analysis generated the augmentation index which will be used for comparison before and after completion of study.
  measure: Change in Glycocalyx - perfused boundary region
  time frame: baseline, up to 6 months
  description: Video recordings of the sublingual vasculature will be performed using the high definition video camera GlycoCheck (Microvascular health solutions). Data collected will include perfused boundary region (um), and will be used for comparison before and after completion of study.
  measure: Change in capillary density
  time frame: baseline, up to 6 months
  description: Video recordings of the sublingual vasculature will be performed using the high definition video camera GlycoCheck (Microvascular health solutions). Data collected will include capillary density (mm/mm^2), and will be used for comparison before and after completion of study.
  measure: Change in red blood cell velocity
  time frame: baseline, up to 6 months
  description: Video recordings of the sublingual vasculature will be performed using the high definition video camera GlycoCheck (Microvascular health solutions). Data collected will include red blood cell velocity (um/sec), and will be used for comparison before and after treatment.
  measure: Change in Attention
  time frame: baseline, up to 6 months
  description: CANTAB research attention test.Reported as a %change from baseline, before and after completion of study.
  measure: Change in Working Memory
  time frame: baseline, up to 6 months
  description: CANTAB research working memory test.Reported as a %change from baseline, before and after completion of study.
  measure: Change in Executive Function
  time frame: baseline, up to 6 months
  description: CANTAB research executive function test.Reported as a %change from baseline, before and after completion of study.
  measure: Change in Processing Speed
  time frame: baseline, up to 6 months
  description: CANTAB research processing speed test.Reported as a %change from baseline, before and after completion of study
  measure: Body composition
  time frame: baseline, up to 6 months
  description: Weight and body composition using a bioimpedance scale. Reported as a %change from baseline, before and after completion of study
  measure: Dietary intakes
  time frame: baseline, up to 6 months
  description: Dietary intake data for 24-hour recalls will be collected and analyzed using the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool, version 2022, developed by the National Cancer Institute (https://epi.grants.cancer.gov/asa24). Estimated dietary intakes will be used to determine whether a participant was in a hypocaloric, eucaloric, or hypercaloric state during the intervention.
  measure: Total daily energy expenditure
  time frame: baseline, up to 6 months
  description: Total daily energy expenditure will be estimated using the Mifflin-St. Jeor equation. Estimated total daily energy expenditure will be used to determine whether a participant was in a hypocaloric, eucaloric, or hypercaloric state during the intervention.
  measure: Change in blood metabolic panel markers
  time frame: baseline, up to 6 months
  description: Complete metabolic panel. Reported as a %change from baseline, before and after completion of study
  arm group label: Time restricted eating
  arm group type: Experimental
  description: not more than 10 hrs. eating window daily goal for 6 months
  intervention type: Other
  intervention name: Time restricted eating
  description: not more than 10 hrs. eating window daily goal for 6 months
  arm group label: Time restricted eating
  other name: intermittent fasting
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: Undecided
  ipd description: unidentified data may be shared via research repositories