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/NCT06021223</url>
    </required_header>
    <id_info>
      <org_study_id>BEC-002</org_study_id>
      <nct_id>NCT06021223</nct_id>
    </id_info>
    <brief_title>The Effects of Chicken Extract on Mental Energy in Healthy Adults and the Underlying Mechanisms</brief_title>
    <official_title>Trial of a Chicken Extract for Improving Mental Energy and Mechanisms of Action in Healthy Adults: A Randomized, Double-blind, Placebo-controlled Exploratory Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Brand's Suntory Asia</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Taipei Medical University Shuang Ho Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Brand's Suntory Asia</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>
        This exploratory trial investigates the effect of a chicken extract supplement on mental&#xD;
        energy and its potential underlying mechanisms of action among healthy adults using a&#xD;
        randomized, double-blind, placebo-controlled clinical trial design. Mental energy is a&#xD;
        multi-dimensional construct comprising transient feelings about fatigue, vigor and motivation&#xD;
        and cognitive performance in terms of sustained attention and reaction time.&#xD;
  &#xD;
        A sub-study investigates the immediate biochemical changes after taking chicken extract.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 22, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2025</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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Reaction time and sustained attention (composite) assessed by Cogstate Brief Battery (CBB)</measure>
      <time_frame>At baseline and on Day 14</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Reaction time assessed by Deary-Liewald reaction time task</measure>
      <time_frame>At baseline and on Day 14</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Sustained attention assessed by psychomotor vigilance test</measure>
      <time_frame>At baseline and on Day 14</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Sustained attention assessed by trail making test</measure>
      <time_frame>At baseline and on Day 14</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Fatigue assessed by Profile of Mood States (POMS)</measure>
      <time_frame>Daily from baseline to Day 14</time_frame>
      <description>POMS-fatigue scores range from 0 to 24, with higher score indicating greater fatigue.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fatigue assessed by visual analogue scale (VAS)</measure>
      <time_frame>Daily from baseline to Day 14</time_frame>
      <description>VAS scores range from 0 to 100, with higher score indicating greater fatigue.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Vigor assessed by Profile of Mood States (POMS)</measure>
      <time_frame>Daily from baseline to Day 14</time_frame>
      <description>POMS-vigor scores range from 0 to 28, with the higher score indicating greater vigor.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Vigor assessed by visual analogue scale (VAS)</measure>
      <time_frame>Daily from baseline to Day 14</time_frame>
      <description>VAS scores range from 0 to 100, with higher score indicating greater vigor.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Motivation assessed by visual analogue scale (VAS)</measure>
      <time_frame>Daily from baseline to Day 14</time_frame>
      <description>VAS scores range from 0 to 100, with higher score indicating greater motivation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cerebral blood flow using arterial spin labelling magnetic resonance imaging (MRI)</measure>
      <time_frame>At baseline and on Day 14</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cerebral oxygenation using functional MRI blood oxygenation level dependent (BOLD) imaging</measure>
      <time_frame>At baseline and on Day 14</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Whole body metabolic rate using indirect calorimetry</measure>
      <time_frame>At baseline and on Day 14</time_frame>
      <description>Resting body metabolic rate will be measured</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Plasma global metabolome (metabolic profile) using liquid chromatography mass spectrometry (LCMS)</measure>
      <time_frame>At baseline and on Day 14</time_frame>
      <description>Plasma samples will be analyzed to putatively identify biomarkers of product intake by comparison of test group with control group using high-performance liquid chromatography coupled to mass spectrometer (LCMS). LCMS analysis allows the simultaneous and non-targeted analysis of a wide array of endogenous and exogenous metabolites.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Salivary cortisol level</measure>
      <time_frame>At baseline and on Day 14</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Plasma carnosine</measure>
      <time_frame>At baseline and on Day 14</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Plasma anserine</measure>
      <time_frame>At baseline and on Day 14</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Plasma L-histidine</measure>
      <time_frame>At baseline and on Day 14</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Plasma methylhistidine</measure>
      <time_frame>At baseline and on Day 14</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Plasma beta-alanine</measure>
      <time_frame>At baseline and on Day 14</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sleep quality measured by modified Pittsburgh Sleep Quality Index (PSQI)</measure>
      <time_frame>At baseline and on Day 14</time_frame>
      <description>In the PSQI, scores from the individual items are used to generate seven &quot;component&quot; scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score, with a range of 0-21 points, with higher scores indicating poorer sleep quality. The modified PSQI measures the sleep quality in the past two weeks.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">189</enrollment>
    <condition>Healthy Adults</condition>
    <arm_group>
      <arm_group_label>Chicken extract supplement (high-dose)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>140ml of chicken extract supplement (high-dose) to be consumed daily for 2 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Chicken extract supplement (low-dose)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>140ml of chicken extract supplement (low-dose) to be consumed daily for 2 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>140ml of placebo (caesinate) to be consumed daily for 2 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Chicken extract supplement (high-dose)</intervention_name>
      <description>140ml of chicken extract supplement (high-dose) to be consumed daily for 2 weeks</description>
      <arm_group_label>Chicken extract supplement (high-dose)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Chicken extract supplement (low-dose)</intervention_name>
      <description>140ml of chicken extract supplement (low-dose) to be consumed daily for 2 weeks</description>
      <arm_group_label>Chicken extract supplement (low-dose)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>140ml of placebo to be consumed daily for 2 weeks</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female at 35-64 years of age&#xD;
  &#xD;
            -  Assessed by investigator to be in good health&#xD;
  &#xD;
            -  Normal cognition based on investigator's clinical judgement per the routine practice&#xD;
  &#xD;
            -  Modified PSQI score &gt; 5&#xD;
  &#xD;
            -  Agree to participate in the study and provide written informed consent&#xD;
  &#xD;
            -  Agree to abstain from herbal extracts or dietary supplements throughout the study&#xD;
               period&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  BMI &lt; 18.5 or ≥ 27 kg/m2&#xD;
  &#xD;
            -  Concurrent pharmacological treatments&#xD;
  &#xD;
            -  Current systemic diseases or current/history of neurological or cerebrovascular&#xD;
               diseases&#xD;
  &#xD;
            -  Active peptic ulcer, or a history of peptic ulcer within the last 2 years&#xD;
  &#xD;
            -  Medications or interventions in the last 4 weeks, which in the investigators'&#xD;
               judgement could potentially affect the outcome measures&#xD;
  &#xD;
            -  Regular significant quantities of dietary supplements or herbal extracts (&gt; 2 times a&#xD;
               week) in the last 4 weeks&#xD;
  &#xD;
            -  Regular excessive caffeine consumption, heavy alcohol consumption or heavy habitual&#xD;
               smokers&#xD;
  &#xD;
            -  Any drastic changes in lifestyle (including diet, smoking, sleep, exercise, and mental&#xD;
               and physical activities) in the last 4 weeks&#xD;
  &#xD;
            -  Not able to maintain the same lifestyle throughout the study period&#xD;
  &#xD;
            -  Inadequate visual and auditory acuity to allow neuropsychological testing per&#xD;
               investigator's judgment&#xD;
  &#xD;
            -  Inability to undergo fMRI scan&#xD;
  &#xD;
            -  Any consumption of chicken extract supplement, or carnosine or anserine supplement, in&#xD;
               the preceding 4 weeks&#xD;
  &#xD;
            -  History of allergy to caseinate, milk, or chicken meat&#xD;
  &#xD;
            -  Women who are pregnant or lactating or intending to do so&#xD;
  &#xD;
            -  Current enrolment in another interventional study&#xD;
  &#xD;
            -  Subjects who show unstable sleep habits during the previous month&#xD;
  &#xD;
            -  Excessive blood donation or blood drawn prior to baseline&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Lee Cheng Phua, PhD</last_name>
      <email>leecheng.phua@suntory.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Taipei Medical University Hospital Shuang Ho Hospital</name>
        <address>
          <city>New Taipei City</city>
          <zip>235</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Mental energy</keyword>
    <keyword>Chicken extract</keyword>
    <keyword>Mechanisms</keyword>
    <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/NCT06021223
  org study id: BEC-002
  nct id: NCT06021223
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This exploratory trial investigates the effect of a chicken extract supplement on mental
        energy and its potential underlying mechanisms of action among healthy adults using a
        randomized, double-blind, placebo-controlled clinical trial design. Mental energy is a
        multi-dimensional construct comprising transient feelings about fatigue, vigor and motivation
        and cognitive performance in terms of sustained attention and reaction time.
  
        A sub-study investigates the immediate biochemical changes after taking chicken extract.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Reaction time and sustained attention (composite) assessed by Cogstate Brief Battery (CBB)
  time frame: At baseline and on Day 14
  measure: Reaction time assessed by Deary-Liewald reaction time task
  time frame: At baseline and on Day 14
  measure: Sustained attention assessed by psychomotor vigilance test
  time frame: At baseline and on Day 14
  measure: Sustained attention assessed by trail making test
  time frame: At baseline and on Day 14
  measure: Fatigue assessed by Profile of Mood States (POMS)
  time frame: Daily from baseline to Day 14
  description: POMS-fatigue scores range from 0 to 24, with higher score indicating greater fatigue.
  measure: Fatigue assessed by visual analogue scale (VAS)
  time frame: Daily from baseline to Day 14
  description: VAS scores range from 0 to 100, with higher score indicating greater fatigue.
  measure: Vigor assessed by Profile of Mood States (POMS)
  time frame: Daily from baseline to Day 14
  description: POMS-vigor scores range from 0 to 28, with the higher score indicating greater vigor.
  measure: Vigor assessed by visual analogue scale (VAS)
  time frame: Daily from baseline to Day 14
  description: VAS scores range from 0 to 100, with higher score indicating greater vigor.
  measure: Motivation assessed by visual analogue scale (VAS)
  time frame: Daily from baseline to Day 14
  description: VAS scores range from 0 to 100, with higher score indicating greater motivation.
  measure: Cerebral blood flow using arterial spin labelling magnetic resonance imaging (MRI)
  time frame: At baseline and on Day 14
  measure: Cerebral oxygenation using functional MRI blood oxygenation level dependent (BOLD) imaging
  time frame: At baseline and on Day 14
  measure: Whole body metabolic rate using indirect calorimetry
  time frame: At baseline and on Day 14
  description: Resting body metabolic rate will be measured
  measure: Plasma global metabolome (metabolic profile) using liquid chromatography mass spectrometry (LCMS)
  time frame: At baseline and on Day 14
  description: Plasma samples will be analyzed to putatively identify biomarkers of product intake by comparison of test group with control group using high-performance liquid chromatography coupled to mass spectrometer (LCMS). LCMS analysis allows the simultaneous and non-targeted analysis of a wide array of endogenous and exogenous metabolites.
  measure: Salivary cortisol level
  time frame: At baseline and on Day 14
  measure: Plasma carnosine
  time frame: At baseline and on Day 14
  measure: Plasma anserine
  time frame: At baseline and on Day 14
  measure: Plasma L-histidine
  time frame: At baseline and on Day 14
  measure: Plasma methylhistidine
  time frame: At baseline and on Day 14
  measure: Plasma beta-alanine
  time frame: At baseline and on Day 14
  measure: Sleep quality measured by modified Pittsburgh Sleep Quality Index (PSQI)
  time frame: At baseline and on Day 14
  description: In the PSQI, scores from the individual items are used to generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score, with a range of 0-21 points, with higher scores indicating poorer sleep quality. The modified PSQI measures the sleep quality in the past two weeks.
  arm group label: Chicken extract supplement (high-dose)
  arm group type: Experimental
  description: 140ml of chicken extract supplement (high-dose) to be consumed daily for 2 weeks
  arm group label: Chicken extract supplement (low-dose)
  arm group type: Experimental
  description: 140ml of chicken extract supplement (low-dose) to be consumed daily for 2 weeks
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: 140ml of placebo (caesinate) to be consumed daily for 2 weeks
  intervention type: Dietary Supplement
  intervention name: Chicken extract supplement (high-dose)
  description: 140ml of chicken extract supplement (high-dose) to be consumed daily for 2 weeks
  arm group label: Chicken extract supplement (high-dose)
  intervention type: Dietary Supplement
  intervention name: Chicken extract supplement (low-dose)
  description: 140ml of chicken extract supplement (low-dose) to be consumed daily for 2 weeks
  arm group label: Chicken extract supplement (low-dose)
  intervention type: Other
  intervention name: Placebo
  description: 140ml of placebo to be consumed daily for 2 weeks
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 35 Years
  maximum age: 64 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lee Cheng Phua, PhD
  email: leecheng.phua@suntory.com
  facility: 
  country: Taiwan
  responsible party type: Sponsor
  sharing ipd: No