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/NCT05997316</url>
    </required_header>
    <id_info>
      <org_study_id>22-2774</org_study_id>
      <secondary_id>1R61AG080615-01</secondary_id>
      <nct_id>NCT05997316</nct_id>
    </id_info>
    <brief_title>Time Restricted Eating for Metabolic and Psychological Optimization</brief_title>
    <acronym>TEMPO</acronym>
    <official_title>Assessing the Feasibility and Acceptability of a Time Restricted Feeding Intervention Among Older Adults With Mild Cognitive Impairment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of North Carolina, Chapel Hill</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Duke University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of North Carolina, Chapel Hill</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Obesity and related metabolic comorbidities have been associated with more than a 4-fold&#xD;
        increased risk of incident cognitive impairment, including Alzheimer's disease and related&#xD;
        dementias (ADRD). Dysfunctional metabolic flexibility is increasingly recognized as a&#xD;
        critical mechanism linking metabolic risk factors to risk of cognitive impairment, although&#xD;
        few studies portable behavioral strategies to enhance metabolic function among individuals at&#xD;
        risk for ADRD. The present study will examine the feasibility and acceptability of a 12-week&#xD;
        time restricted feeding intervention among individuals with mild cognitive impairment (MCI).&#xD;
        Changes in cognitive and metabolic function will also be examined.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Obese older adults with mild cognitive impairment with mild cognitive impairment will be&#xD;
        asked to participate in a 12 week time restricted fasting intervention. Working with a&#xD;
        behavioral psychologist, they will adapt the timing their eating patterns to incorporate 2-3&#xD;
        days per week with a 16 hour fasting period, typically lasting from after dinner to lunch the&#xD;
        next day. The behavioral intervention will titrate fasting using established behavioral&#xD;
        change techniques, with early phase sessions focusing on organizational principles to prepare&#xD;
        for weekly fasting scheduling and acceptance-based psychological coping skills, including the&#xD;
        ability to tolerate symptoms of hunger and discomfort that may accompany fasting. After&#xD;
        treatment initiation, sessions will focus on broadening fasting behaviors for flexible&#xD;
        adoption across different contexts and to enhance maintenance of fasting patterns. At&#xD;
        baseline and following treatment, participants will undergo tests of cognitive and metabolic&#xD;
        function to assess memory, executive function, metabolic flexibility, and inflammation. At&#xD;
        both time points, participants will also undergo an abbreviated assessment of cognitive and&#xD;
        metabolic function under fasting conditions to assess for any cognitive weaknesses unmasked&#xD;
        during periods of brief metabolic 'stress'.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 7, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Assessors will be blinded to the participant's intervention fidelity and engagement.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Memory</measure>
      <time_frame>Baseline and 12 Weeks</time_frame>
      <description>The primary Memory outcome measure will be a mean-rank, global score comprised of the following subtests. The Hopkins Verbal Learning Test Revised will assess verbal memory on a list learning task. Scores range from 0 to 12 across three learning trials with higher scores indicating better performance. A total learning score therefore ranges from 0 to 36 and a delayed memory score of 0 to 12, with higher scores reflecting better performance. The Brief Visual Memory Test - Revised will be used to assess visual learning and memory. Scores range from 0 to 12 across three learning trials with higher scores indicating better performance. A total learning score therefore ranges from 0 to 36 and a delayed memory score of 0 to 12, with higher scores reflecting better performance.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Executive Function</measure>
      <time_frame>Baseline and 12 Weeks</time_frame>
      <description>Executive Function will be assessed using a mean-rank score comprised of the following subtests. The Trail Making Test assesses complex attention, with scores ranging from 10-300 seconds and higher scores reflecting worse performance. The Digit Span task assesses working memory with scores ranging from 0 to 30 and higher scores reflecting better performance. The Digit Symbol Substitution Test assesses visual psychomotor sequencing with scores ranging from 0 to 133 and higher scores reflecting better performance. The Controlled Oral Word Association test assesses verbal flexibility and phonemic fluency over 3, 1-minute time periods, with higher scores reflecting better performance. The Animal Naming Test assesses semantic fluency over 1-minute, with higher scores reflecting better performance. The Stroop Test assess inhibitory control, with higher scores reflecting better performance. The Ruff 2&amp;7 Test assesses psychomotor vigilance, with higher scores reflecting better performance.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Metabolic Flexibility</measure>
      <time_frame>Baseline and 12 Weeks</time_frame>
      <description>Metabolic flexibility and function will be assessed using a mean-rank, global score comprised of the following biomarkers. Metabolic measures will include Lipids, triglycerides, glucose, insulin, insulin-like growth factor, HbA1c, non-esterified fatty acids, total ketone bodies, brain derived neurotrophic factor, beta-hydroxybutyrate, lactate, amino acids, plasma kynurenine, kynurenic acid, tryptophan, non-esterified fatty acids, and acylcarnitines. All individual biomarkers will be ranked at pre and post treatment before being combined into a mean-rank, global score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Inflammatory Function</measure>
      <time_frame>Baseline and 12 Weeks</time_frame>
      <description>Inflammatory function will be assessed using a mean-rank, global score comprised of the following biomarkers. Inflammatory markers will include interleukin6 (IL-6), tumor necrosis factor (TNF)-alpha, high sensitivity C reactive protein (CRP), IL-1β, IL-8, IL-10, myostatin, and glial fibrillary acidic protein (GFAP). All individual biomarkers will be ranked at pre and post treatment before being combined into a mean-rank, global score.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Mild Cognitive Impairment</condition>
    <condition>Obesity</condition>
    <arm_group>
      <arm_group_label>Time restricted eating</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will engage in a 12-week time restricted fasting intervention. Each week, participants will work with a clinical psychologist to modify the timing of their eating behaviors to adhere to a 16-hour fast, 2-3 days per week.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Time restricted eating</intervention_name>
      <description>Participants will work with a psychologist towards achieving a 16 hour fasting period, 2-3 days per week. The intervention will last 12 weeks, with different intervention materials gradually introduced over the course of the 12 weeks.</description>
      <arm_group_label>Time restricted eating</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Subjects will include those men and women:&#xD;
  &#xD;
            -  aged 65-80 years,&#xD;
  &#xD;
            -  with amnestic Mild Cognitive Impairment (Montreal Cognitive Assessment Battery score&#xD;
               [MoCA] total score 19-25; and score of &gt; 1.0 on the Mail-in Cognitive Function&#xD;
               Screening Instrument),&#xD;
  &#xD;
            -  obese (body mass index 30-40 kg/m^2),&#xD;
  &#xD;
            -  sedentary, and&#xD;
  &#xD;
            -  willing to participate in all aspects of the proposed intervention.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Reasons for participant exclusion will include:&#xD;
  &#xD;
            -  secondary causes of obesity,&#xD;
  &#xD;
            -  evidence of clinical dementia (MoCA score &lt; 18), severe chronic kidney disease (eGFR&#xD;
               &lt;45 ml/min/1.73m^2),&#xD;
  &#xD;
            -  heart failure,&#xD;
  &#xD;
            -  high grade arrhythmias,&#xD;
  &#xD;
            -  severe valvular heart disease,&#xD;
  &#xD;
            -  severe asthma or chronic obstructive lung disease,&#xD;
  &#xD;
            -  diabetes requiring insulin,&#xD;
  &#xD;
            -  musculoskeletal or neurologic problems that would preclude participation in aerobic&#xD;
               exercise training,&#xD;
  &#xD;
            -  a major psychiatric disorder,&#xD;
  &#xD;
            -  a history of drug abuse,&#xD;
  &#xD;
            -  alcohol consumption &gt;14 drinks/week,&#xD;
  &#xD;
            -  gastric bypass surgery,&#xD;
  &#xD;
            -  non-English speaking, or&#xD;
  &#xD;
            -  a life-limiting comorbid medical condition (e.g. cancer).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Patrick J Smith, PhD, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of North Carolina, Chapel Hill</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Caroline Nelson, MPH, RD</last_name>
      <phone>(919) 966-6085</phone>
      <email>tempo@unc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Patrick J Smith, PhD, MPH</last_name>
      <phone>(919) 843-6884</phone>
      <email>patrick_smith@med.unc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of North Carolina</name>
        <address>
          <city>Chapel Hill</city>
          <state>North Carolina</state>
          <zip>27519</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Patrick J Smith, PhD, MPH</last_name>
        <phone>919-843-6884</phone>
        <email>patrick_smith@med.unc.edu</email>
      </contact>
      <contact_backup>
        <last_name>Caroline Nelson, MPH, RD</last_name>
        <phone>(919) 966-6085</phone>
        <email>tempo@unc.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 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>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>We will submit de-identified study data to a public database in accordance with the NIH data sharing policy. Datasets will be prepared and submitted to the appropriate program officer no later than 3 years after all patient follow up is complete or 2 years after main manuscript publication of study results (whichever comes first). Dr. Smith will also include documentation and key study documents such as protocol, electronic case report forms, manuals of procedures, and applicable training materials to enable the use of prepared data sets by outside investigators. Data sets and associated documentation will be provided in the preferred electronic format. The prepared and submitted data set will include at minimum baseline, interim visit, procedural and intervention based data, and outcomes data.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
    </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/NCT05997316
  org study id: 22-2774
  secondary id: 1R61AG080615-01
  nct id: NCT05997316
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Obesity and related metabolic comorbidities have been associated with more than a 4-fold
        increased risk of incident cognitive impairment, including Alzheimer's disease and related
        dementias (ADRD). Dysfunctional metabolic flexibility is increasingly recognized as a
        critical mechanism linking metabolic risk factors to risk of cognitive impairment, although
        few studies portable behavioral strategies to enhance metabolic function among individuals at
        risk for ADRD. The present study will examine the feasibility and acceptability of a 12-week
        time restricted feeding intervention among individuals with mild cognitive impairment (MCI).
        Changes in cognitive and metabolic function will also be examined.
  Obese older adults with mild cognitive impairment with mild cognitive impairment will be
        asked to participate in a 12 week time restricted fasting intervention. Working with a
        behavioral psychologist, they will adapt the timing their eating patterns to incorporate 2-3
        days per week with a 16 hour fasting period, typically lasting from after dinner to lunch the
        next day. The behavioral intervention will titrate fasting using established behavioral
        change techniques, with early phase sessions focusing on organizational principles to prepare
        for weekly fasting scheduling and acceptance-based psychological coping skills, including the
        ability to tolerate symptoms of hunger and discomfort that may accompany fasting. After
        treatment initiation, sessions will focus on broadening fasting behaviors for flexible
        adoption across different contexts and to enhance maintenance of fasting patterns. At
        baseline and following treatment, participants will undergo tests of cognitive and metabolic
        function to assess memory, executive function, metabolic flexibility, and inflammation. At
        both time points, participants will also undergo an abbreviated assessment of cognitive and
        metabolic function under fasting conditions to assess for any cognitive weaknesses unmasked
        during periods of brief metabolic 'stress'.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: Assessors will be blinded to the participant's intervention fidelity and engagement.
  measure: Memory
  time frame: Baseline and 12 Weeks
  description: The primary Memory outcome measure will be a mean-rank, global score comprised of the following subtests. The Hopkins Verbal Learning Test Revised will assess verbal memory on a list learning task. Scores range from 0 to 12 across three learning trials with higher scores indicating better performance. A total learning score therefore ranges from 0 to 36 and a delayed memory score of 0 to 12, with higher scores reflecting better performance. The Brief Visual Memory Test - Revised will be used to assess visual learning and memory. Scores range from 0 to 12 across three learning trials with higher scores indicating better performance. A total learning score therefore ranges from 0 to 36 and a delayed memory score of 0 to 12, with higher scores reflecting better performance.
  measure: Executive Function
  time frame: Baseline and 12 Weeks
  description: Executive Function will be assessed using a mean-rank score comprised of the following subtests. The Trail Making Test assesses complex attention, with scores ranging from 10-300 seconds and higher scores reflecting worse performance. The Digit Span task assesses working memory with scores ranging from 0 to 30 and higher scores reflecting better performance. The Digit Symbol Substitution Test assesses visual psychomotor sequencing with scores ranging from 0 to 133 and higher scores reflecting better performance. The Controlled Oral Word Association test assesses verbal flexibility and phonemic fluency over 3, 1-minute time periods, with higher scores reflecting better performance. The Animal Naming Test assesses semantic fluency over 1-minute, with higher scores reflecting better performance. The Stroop Test assess inhibitory control, with higher scores reflecting better performance. The Ruff 2&7 Test assesses psychomotor vigilance, with higher scores reflecting better performance.
  measure: Metabolic Flexibility
  time frame: Baseline and 12 Weeks
  description: Metabolic flexibility and function will be assessed using a mean-rank, global score comprised of the following biomarkers. Metabolic measures will include Lipids, triglycerides, glucose, insulin, insulin-like growth factor, HbA1c, non-esterified fatty acids, total ketone bodies, brain derived neurotrophic factor, beta-hydroxybutyrate, lactate, amino acids, plasma kynurenine, kynurenic acid, tryptophan, non-esterified fatty acids, and acylcarnitines. All individual biomarkers will be ranked at pre and post treatment before being combined into a mean-rank, global score.
  measure: Inflammatory Function
  time frame: Baseline and 12 Weeks
  description: Inflammatory function will be assessed using a mean-rank, global score comprised of the following biomarkers. Inflammatory markers will include interleukin6 (IL-6), tumor necrosis factor (TNF)-alpha, high sensitivity C reactive protein (CRP), IL-1β, IL-8, IL-10, myostatin, and glial fibrillary acidic protein (GFAP). All individual biomarkers will be ranked at pre and post treatment before being combined into a mean-rank, global score.
  arm group label: Time restricted eating
  arm group type: Experimental
  description: Participants will engage in a 12-week time restricted fasting intervention. Each week, participants will work with a clinical psychologist to modify the timing of their eating behaviors to adhere to a 16-hour fast, 2-3 days per week.
  intervention type: Behavioral
  intervention name: Time restricted eating
  description: Participants will work with a psychologist towards achieving a 16 hour fasting period, 2-3 days per week. The intervention will last 12 weeks, with different intervention materials gradually introduced over the course of the 12 weeks.
  arm group label: Time restricted eating
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Patrick J Smith, PhD, MPH
  role: Principal Investigator
  affiliation: University of North Carolina, Chapel Hill
  last name: Caroline Nelson, MPH, RD
  phone: (919) 966-6085
  email: tempo@unc.edu
  last name: Patrick J Smith, PhD, MPH
  phone: (919) 843-6884
  email: patrick_smith@med.unc.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: Cognitive Dysfunction
  sharing ipd: Yes
  ipd description: We will submit de-identified study data to a public database in accordance with the NIH data sharing policy. Datasets will be prepared and submitted to the appropriate program officer no later than 3 years after all patient follow up is complete or 2 years after main manuscript publication of study results (whichever comes first). Dr. Smith will also include documentation and key study documents such as protocol, electronic case report forms, manuals of procedures, and applicable training materials to enable the use of prepared data sets by outside investigators. Data sets and associated documentation will be provided in the preferred electronic format. The prepared and submitted data set will include at minimum baseline, interim visit, procedural and intervention based data, and outcomes data.
  ipd info type: Study Protocol