<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/NCT03288077</url>
  </required_header>
  <id_info>
    <org_study_id>PEP-1420</org_study_id>
    <nct_id>NCT03288077</nct_id>
  </id_info>
  <brief_title>Nutrients to Enhance Sleep Quality and Quantity</brief_title>
  <official_title>Nutrients to Enhance Sleep Quality and Quantity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PepsiCo Global R&amp;D</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PepsiCo Global R&amp;D</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>
      Identifying non-pharmacological means of enhancing sleep is an important area of research for&#xD;
      elite athletes. Research completed at the AIS has identified that some athletes have&#xD;
      difficulties falling and staying asleep during both training and competition.&#xD;
&#xD;
      There are a number of dietary components such as nutrients and certain dietary supplements&#xD;
      that are purported to decrease sleep latency and increase quality of sleep. While many of&#xD;
      these interventions have been investigated in isolation, no research has examined different&#xD;
      combinations and/or amounts of these substances to determine the resultant effects on sleep.&#xD;
      The results of such a systematic investigation could produce an effective diet based sleep&#xD;
      product (&quot;Sleep Drink').&#xD;
&#xD;
      The optimal components, amounts, and timing of intake of such a Sleep Drink will be explored.&#xD;
      Additionally, the effects on sleep will be evaluated using the gold standard of sleep&#xD;
      measurement: polysomnography.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2015</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</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>polysomnography</measure>
    <time_frame>0-3 hours</time_frame>
    <description>The effect of the drinks will be determined primarily by polysomnography</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Sleepiness in Athletes</condition>
  <arm_group>
    <arm_group_label>Triptophan beverage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Proprietary blend of nutritional interventions aimed at increasing sleepiness</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tryptophan</intervention_name>
    <description>Beverage including tryptophan</description>
    <arm_group_label>Triptophan beverage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-40 year old males&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion: Exclusion criteria will include any observed or disclosed injury, illness,&#xD;
             sleep or health issue which may disrupt the subject's performance or endanger their&#xD;
             health. Participants will need to complete an adult screening tool, as recommended by&#xD;
             Exercise and Sports Science Australia (ESSA), to assess this.&#xD;
&#xD;
          -  Blood samples will also be collected to screen for magnesium, zinc and B12 which may&#xD;
             influence nutritional impact on sleep. If subjects score above the reference ranges&#xD;
             for these measures, they will be excluded.&#xD;
&#xD;
          -  The Pittsburg Sleep Quality Index (PSQI) and Stanford Sleepiness Scale (SSS) will be&#xD;
             used to screen for sleep disturbances. If subjects score outside the reference ranges&#xD;
             for these questionnaires, they will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shona Halson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AIS</affiliation>
  </overall_official>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>September 13, 2018</last_update_submitted>
  <last_update_submitted_qc>September 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2018</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>Sleepiness</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tryptophan</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03288077
org study id: PEP-1420
nct id: NCT03288077
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Identifying non-pharmacological means of enhancing sleep is an important area of research for
      elite athletes. Research completed at the AIS has identified that some athletes have
      difficulties falling and staying asleep during both training and competition.

      There are a number of dietary components such as nutrients and certain dietary supplements
      that are purported to decrease sleep latency and increase quality of sleep. While many of
      these interventions have been investigated in isolation, no research has examined different
      combinations and/or amounts of these substances to determine the resultant effects on sleep.
      The results of such a systematic investigation could produce an effective diet based sleep
      product ("Sleep Drink').

      The optimal components, amounts, and timing of intake of such a Sleep Drink will be explored.
      Additionally, the effects on sleep will be evaluated using the gold standard of sleep
      measurement: polysomnography.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: polysomnography
time frame: 0-3 hours
description: The effect of the drinks will be determined primarily by polysomnography
arm group label: Triptophan beverage
arm group type: Experimental
description: Proprietary blend of nutritional interventions aimed at increasing sleepiness
intervention type: Other
intervention name: Tryptophan
description: Beverage including tryptophan
arm group label: Triptophan beverage
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shona Halson, PhD
role: Principal Investigator
affiliation: AIS
responsible party type: Sponsor
mesh term: Sleepiness
mesh term: Tryptophan
sharing ipd: No