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/NCT05968144</url>
    </required_header>
    <id_info>
      <org_study_id>HP-00106546</org_study_id>
      <nct_id>NCT05968144</nct_id>
    </id_info>
    <brief_title>Towards Understanding Between ADT Treatment, Circadian Rhythm, and Physiological Responsiveness</brief_title>
    <acronym>ADRIAN</acronym>
    <official_title>ADRIAN: Towards Understanding of ADT Treatment and Dietary Patterns, Circadian Rhythm, Physiological Responsiveness, and Frailty</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Maryland, Baltimore</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Maryland, Baltimore</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>
        Frailty is one of the main reasons older adults lose independence. Frailty describes a&#xD;
        reduced ability to withstand stress on the physiological scale, or a reduced physiological&#xD;
        reserve. The theory is that entrainment of circadian rhythm via time-restricted eating will&#xD;
        improve the body's ability to predict energy supply and demand, and therefore enable the body&#xD;
        to allocate more resources to anabolic processes and promote resilience to cancer treatment,&#xD;
        thereby preventing the progression of frailty. A total of 30 individuals over 55 years old&#xD;
        undergoing ADT therapy for prostate cancer will be recruited. Participants will be randomized&#xD;
        1:1 to a 12-week TRE intervention or a time-unrestricted nutrition control intervention. At&#xD;
        baseline and post-intervention, Fried's Frailty Index will be used to assess frailty, and a&#xD;
        novel set of five physiological responsiveness measures will be used to assess physiological&#xD;
        responsiveness-1) lying-to-standing blood pressure, 2) heart rate variability, 3) oral&#xD;
        glucose tolerance test, 4) 24-hour circadian cortisol rhythm, and 5) usual vs. fast gait&#xD;
        speed. These data will allow assessment of 1) the feasibility of TRE among patients with&#xD;
        prostate cancer during ADT treatment with the ultimate goal of optimizing an intervention to&#xD;
        prevent the progression of frailty, and 2) the effects of TRE vs. control on frailty and&#xD;
        physiological responsiveness.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Frailty affects more than 5.4 million people over the age of 65 in the United States (&gt;10%)&#xD;
        and is one of the main reasons older adults lose independence. Frailty describes a reduced&#xD;
        ability to withstand stress on the physiological scale, or a reduced physiological reserve.&#xD;
        It is characterized by five key signs and symptoms, known as Fried's frailty criteria:&#xD;
        weakness, slow walking speed, low physical activity, fatigue or exhaustion, and unintentional&#xD;
        weight loss. Frailty does not progress linearly; its pathogenesis often accelerates in&#xD;
        response to a &quot;stressor event&quot; such as an illness (e.g., coronavirus), the death of a spouse,&#xD;
        or cancer treatment. For example, a diagnosis with prostate cancer and androgen deprivation&#xD;
        therapy (ADT) treatment are associated with accelerated frailty. While the body is resilient&#xD;
        to everyday stressors, these large-scale, enduring stressors can accumulate and cause the&#xD;
        body to have difficulty predicting energy supply and demand. The result is that&#xD;
        stress-induced energy costs compete with cellular growth, maintenance, and repair, i.e.,&#xD;
        frailty. Treatments for frailty are intensive (e.g., weight training) and often unsuccessful,&#xD;
        and there is a critical need to develop effective interventions to complement and replace&#xD;
        these interventions to prevent and treat frailty.&#xD;
  &#xD;
        The theory is that entrainment of circadian rhythm, or the body's internal body clock, will&#xD;
        improve the body's ability to predict energy supply and demand, and therefore enable the body&#xD;
        to allocate more resources to anabolic processes and promote resilience to cancer treatment,&#xD;
        thereby preventing the progression of frailty. Time-restricted eating (TRE) entails consuming&#xD;
        food within a defined, consistent window every day. It has emerged as a powerful intervention&#xD;
        to entrain circadian rhythm and regulate metabolic homeostasis. The hypothesis is that, by&#xD;
        entraining circadian rhythm, TRE can enhance physiological regulation and prevent&#xD;
        stressor-induced frailty.&#xD;
  &#xD;
        A total of 30 patients over 55 years old undergoing ADT therapy for prostate cancer will be&#xD;
        recruited. Participants will be randomized 1:1 to a 12-week TRE intervention or a time- and&#xD;
        attention nutrition control; both groups will be under the supervision of a licensed clinical&#xD;
        nutritionist with expertise in the cancer population to ensure adequate macronutrient intake.&#xD;
        At baseline and post-intervention, a novel set of five physiological responsiveness measures&#xD;
        and frailty using Fried's Frailty Index will be assessed. These data will allow assessment of&#xD;
        Aim 1) the feasibility of TRE among patients with prostate cancer during ADT treatment with&#xD;
        the ultimate goal of optimizing an intervention to prevent the progression of frailty and Aim&#xD;
        2) the effects of TRE on: a) Fried's Frailty Index, b) lying-to-standing blood pressure, c)&#xD;
        heart rate variability, d) oral glucose tolerance, e) 24-hour circadian cortisol rhythm, and&#xD;
        f) usual vs. fast gait speed.&#xD;
  &#xD;
        This project is innovative and clinically important because once frailty is diagnosed, it is&#xD;
        difficult to treat. This project tests a novel theoretical framework that a low cost, widely&#xD;
        accessible dietary intervention-TRE-can entrain circadian rhythm and improve physiological&#xD;
        reserve in the context of ADT treatment for prostate cancer, thereby preventing progression&#xD;
        to frailty.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">December 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2026</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>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Outcome assessors will be blinded when possible (e.g., salivary cortisol concentration)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility, as assessed by the percentage of participants who enrolled completed the study</measure>
      <time_frame>12 weeks</time_frame>
      <description>To assess feasibility, the percentage of participants who provide evaluable data regarding their eating window at baseline and 12 weeks will be assessed.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The effects of TRE on frailty, as measured using Fried's Frailty criteria</measure>
      <time_frame>12 weeks</time_frame>
      <description>Fried's Frailty scores will be compared for those in the time-restricted eating group vs. the control group at week 12, controlling for baseline levels. This assessment entails recent weight loss, handgrip strength, self-reported exhaustion, walking speed; and habitual physical activity. The score is from 0-5, with a higher score indicating a higher degree of frailty.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Prostatic Neoplasm</condition>
    <condition>Survivorship</condition>
    <condition>Frailty</condition>
    <condition>Aging</condition>
    <arm_group>
      <arm_group_label>Time-restricted eating</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will meet with a nutritionist to discuss dietary recommendations for patients with prostate cancer undergoing ADT. Participants will self-select a 10-hour window in which to consume all food and beverages (with the exception of black coffee and unsweetened tea in the mornings; water is okay at all times).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Unrestricted eating</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will meet with a nutritionist to discuss dietary recommendations for patients with prostate cancer undergoing ADT. Participants will try to follow recommendations will no suggestion for meal timing.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Dietary recommendations</intervention_name>
      <description>One-on-one meeting with a nutritionist to discuss and personalize dietary recommendations for patients with prostate cancer undergoing ADT.</description>
      <arm_group_label>Time-restricted eating</arm_group_label>
      <arm_group_label>Unrestricted eating</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Time-restricted eating</intervention_name>
      <description>12 weeks of time-restricted eating (10-hour window)</description>
      <arm_group_label>Time-restricted eating</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Have a diagnosis of prostate cancer&#xD;
  &#xD;
            -  Be undergoing androgen deprivation therapy&#xD;
  &#xD;
            -  Be 55 years old or older&#xD;
  &#xD;
            -  Speak and/or read English&#xD;
  &#xD;
            -  Be able and willing to adhere to the study procedures&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Already eat all their food in a window that is 10 h or shorter on most (6/7) days of&#xD;
               the week&#xD;
  &#xD;
            -  Be underweight (≤18.5 kg/m2)&#xD;
  &#xD;
            -  Have surgery planned during the study duration&#xD;
  &#xD;
            -  Have lost more than 10 pounds unintentionally in the last 12 months&#xD;
  &#xD;
            -  Have any contraindications to the proposed nutrition intervention as identified by&#xD;
               their medical provider, their designee, or the study team (e.g., type 1 diabetes, risk&#xD;
               for hypoglycemia, medication requirements, recent history of an eating disorder)&#xD;
  &#xD;
            -  Be on artificial nutrition&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Amber Kleckner, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Maryland, Baltimore</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Amber Kleckner, PhD</last_name>
      <phone>410-706-5961</phone>
      <email>amber.kleckner@umaryland.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Maryland, Baltimore</name>
        <address>
          <city>Baltimore</city>
          <state>Maryland</state>
          <zip>21201</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Nutrition</keyword>
    <keyword>Circadian rhythm</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prostatic Neoplasms</mesh_term>
      <mesh_term>Frailty</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/NCT05968144
  org study id: HP-00106546
  nct id: NCT05968144
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Frailty is one of the main reasons older adults lose independence. Frailty describes a
        reduced ability to withstand stress on the physiological scale, or a reduced physiological
        reserve. The theory is that entrainment of circadian rhythm via time-restricted eating will
        improve the body's ability to predict energy supply and demand, and therefore enable the body
        to allocate more resources to anabolic processes and promote resilience to cancer treatment,
        thereby preventing the progression of frailty. A total of 30 individuals over 55 years old
        undergoing ADT therapy for prostate cancer will be recruited. Participants will be randomized
        1:1 to a 12-week TRE intervention or a time-unrestricted nutrition control intervention. At
        baseline and post-intervention, Fried's Frailty Index will be used to assess frailty, and a
        novel set of five physiological responsiveness measures will be used to assess physiological
        responsiveness-1) lying-to-standing blood pressure, 2) heart rate variability, 3) oral
        glucose tolerance test, 4) 24-hour circadian cortisol rhythm, and 5) usual vs. fast gait
        speed. These data will allow assessment of 1) the feasibility of TRE among patients with
        prostate cancer during ADT treatment with the ultimate goal of optimizing an intervention to
        prevent the progression of frailty, and 2) the effects of TRE vs. control on frailty and
        physiological responsiveness.
  Frailty affects more than 5.4 million people over the age of 65 in the United States (>10%)
        and is one of the main reasons older adults lose independence. Frailty describes a reduced
        ability to withstand stress on the physiological scale, or a reduced physiological reserve.
        It is characterized by five key signs and symptoms, known as Fried's frailty criteria:
        weakness, slow walking speed, low physical activity, fatigue or exhaustion, and unintentional
        weight loss. Frailty does not progress linearly; its pathogenesis often accelerates in
        response to a "stressor event" such as an illness (e.g., coronavirus), the death of a spouse,
        or cancer treatment. For example, a diagnosis with prostate cancer and androgen deprivation
        therapy (ADT) treatment are associated with accelerated frailty. While the body is resilient
        to everyday stressors, these large-scale, enduring stressors can accumulate and cause the
        body to have difficulty predicting energy supply and demand. The result is that
        stress-induced energy costs compete with cellular growth, maintenance, and repair, i.e.,
        frailty. Treatments for frailty are intensive (e.g., weight training) and often unsuccessful,
        and there is a critical need to develop effective interventions to complement and replace
        these interventions to prevent and treat frailty.
  
        The theory is that entrainment of circadian rhythm, or the body's internal body clock, will
        improve the body's ability to predict energy supply and demand, and therefore enable the body
        to allocate more resources to anabolic processes and promote resilience to cancer treatment,
        thereby preventing the progression of frailty. Time-restricted eating (TRE) entails consuming
        food within a defined, consistent window every day. It has emerged as a powerful intervention
        to entrain circadian rhythm and regulate metabolic homeostasis. The hypothesis is that, by
        entraining circadian rhythm, TRE can enhance physiological regulation and prevent
        stressor-induced frailty.
  
        A total of 30 patients over 55 years old undergoing ADT therapy for prostate cancer will be
        recruited. Participants will be randomized 1:1 to a 12-week TRE intervention or a time- and
        attention nutrition control; both groups will be under the supervision of a licensed clinical
        nutritionist with expertise in the cancer population to ensure adequate macronutrient intake.
        At baseline and post-intervention, a novel set of five physiological responsiveness measures
        and frailty using Fried's Frailty Index will be assessed. These data will allow assessment of
        Aim 1) the feasibility of TRE among patients with prostate cancer during ADT treatment with
        the ultimate goal of optimizing an intervention to prevent the progression of frailty and Aim
        2) the effects of TRE on: a) Fried's Frailty Index, b) lying-to-standing blood pressure, c)
        heart rate variability, d) oral glucose tolerance, e) 24-hour circadian cortisol rhythm, and
        f) usual vs. fast gait speed.
  
        This project is innovative and clinically important because once frailty is diagnosed, it is
        difficult to treat. This project tests a novel theoretical framework that a low cost, widely
        accessible dietary intervention-TRE-can entrain circadian rhythm and improve physiological
        reserve in the context of ADT treatment for prostate cancer, thereby preventing progression
        to frailty.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  masking description: Outcome assessors will be blinded when possible (e.g., salivary cortisol concentration)
  measure: Feasibility, as assessed by the percentage of participants who enrolled completed the study
  time frame: 12 weeks
  description: To assess feasibility, the percentage of participants who provide evaluable data regarding their eating window at baseline and 12 weeks will be assessed.
  measure: The effects of TRE on frailty, as measured using Fried's Frailty criteria
  time frame: 12 weeks
  description: Fried's Frailty scores will be compared for those in the time-restricted eating group vs. the control group at week 12, controlling for baseline levels. This assessment entails recent weight loss, handgrip strength, self-reported exhaustion, walking speed; and habitual physical activity. The score is from 0-5, with a higher score indicating a higher degree of frailty.
  arm group label: Time-restricted eating
  arm group type: Experimental
  description: Participants will meet with a nutritionist to discuss dietary recommendations for patients with prostate cancer undergoing ADT. Participants will self-select a 10-hour window in which to consume all food and beverages (with the exception of black coffee and unsweetened tea in the mornings; water is okay at all times).
  arm group label: Unrestricted eating
  arm group type: Active Comparator
  description: Participants will meet with a nutritionist to discuss dietary recommendations for patients with prostate cancer undergoing ADT. Participants will try to follow recommendations will no suggestion for meal timing.
  intervention type: Behavioral
  intervention name: Dietary recommendations
  description: One-on-one meeting with a nutritionist to discuss and personalize dietary recommendations for patients with prostate cancer undergoing ADT.
  arm group label: Time-restricted eating
  arm group label: Unrestricted eating
  intervention type: Behavioral
  intervention name: Time-restricted eating
  description: 12 weeks of time-restricted eating (10-hour window)
  arm group label: Time-restricted eating
  criteria: 
  gender: Male
  minimum age: 55 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Amber Kleckner, PhD
  role: Principal Investigator
  affiliation: University of Maryland, Baltimore
  last name: Amber Kleckner, PhD
  phone: 410-706-5961
  email: amber.kleckner@umaryland.edu
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Prostatic Neoplasms
  mesh term: Frailty
  sharing ipd: No