<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/NCT04505800</url>
  </required_header>
  <id_info>
    <org_study_id>YM106114F</org_study_id>
    <nct_id>NCT04505800</nct_id>
  </id_info>
  <brief_title>Tryptophan Supplementation to Improve Night Shift Workers' Health</brief_title>
  <official_title>Chrononutrition of Using L-tryptophan Supplementation to Alleviate the Impacts of Night Shift Rotation on Circadian Hormones and Health Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Yang Ming University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Yang Ming University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized cross-over double-blinded trial aims to investigate the health effect of oral&#xD;
      l-tryptophan supplementation on workers who rotate night shift work, and to examine the&#xD;
      influences of different frequencies and timings of supplementation on the health effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to investigate the health effect of oral l-tryptophan supplementation on&#xD;
      workers who rotate night shift work, and to examine the influences of different frequencies&#xD;
      and timings of supplementation on the health effects. Night shift work affects melatonin and&#xD;
      cortisol variation, insomnia, mood issues, and metabolic syndrome. Short-term tryptophan&#xD;
      supplementation was shown to improve melatonin, sleep quality, and cortisol response to acute&#xD;
      stress. Little is known whether a longer term of longer-term tryptophan supplementation would&#xD;
      alleviate the health impacts of night shift work. Nevertheless, melatonin and cortisol have&#xD;
      their normal circadian patterns. Nothing is known about what temporal structure of tryptophan&#xD;
      supplement would maximize its health effects on night shift workers melatonin and cortisol&#xD;
      levels. We will conduct a double-blind cross-over randomized controlled trial to examine the&#xD;
      benefits of oral tryptophan administration (3g/day, t.i.d.) on night shift workers' health&#xD;
      outcomes: melatonin and cortisol levels, sleep quality, moods and work performance. We expect&#xD;
      to reveal the health effect of tryptophan supplementation in night shift workers by using&#xD;
      sophisticated study design.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2020</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Melatonin level in the morning</measure>
    <time_frame>3 weeks</time_frame>
    <description>Morning (8AM) saliva melatonin level change in the phase</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Melatonin level in the afternoon</measure>
    <time_frame>3 weeks</time_frame>
    <description>Afternoon (4PM) saliva melatonin level change in the phase</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Melatonin level at midnight</measure>
    <time_frame>3 weeks</time_frame>
    <description>Midnight (0AM) saliva melatonin level change in the phase</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cortisol level in the morning</measure>
    <time_frame>3 weeks</time_frame>
    <description>Morning (8AM) saliva cortisol level change in the phase</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cortisol level in the afternoon</measure>
    <time_frame>3 weeks</time_frame>
    <description>Afternoon (4PM) saliva cortisol level change in the phase</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cortisol level at midnight</measure>
    <time_frame>3 weeks</time_frame>
    <description>Midnight (0AM) saliva cortisol level change in the phase</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>3 weeks</time_frame>
    <description>Pittsburg Sleep Quality Score (range: 0-21) at the end of the phase. The higher score indicates worse sleep quality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood states, depression</measure>
    <time_frame>3 weeks</time_frame>
    <description>Depression, Anxiety, Stress Scales. Depression score (range 0-42) changes in the phase. The higher score, the more depressed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood states, anxiety</measure>
    <time_frame>3 weeks</time_frame>
    <description>Depression, Anxiety, Stress Scales. Anxiety score (range 0-42) changes in the phase. The higher score, the more anxious.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood states, stress</measure>
    <time_frame>3 weeks</time_frame>
    <description>Depression, Anxiety, Stress Scales. Stress score (range 0-42) changes in the phase. The higher score, the more stressful.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Sleep</condition>
  <condition>Mood</condition>
  <condition>Burnout</condition>
  <condition>Melatonin Deficiency</condition>
  <condition>Cortisol Deficiency</condition>
  <arm_group>
    <arm_group_label>Tryptophan supplement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pure L-tryptophan in capsules (500mg/capsule)&#xD;
3g tryptophan per day (2 capsules, t.i.d.), at 8AM, 4PM, and 0AM (± 1 hour)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maltose</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo is maltose powder capsule (500mg/capsule)&#xD;
3g maltose powder per day (2 capsules, t.i.d.), at 8AM, 4PM, and 0AM (± 1 hour)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Tryptophan supplement</intervention_name>
    <description>Pure L-tryptophan in capsules (500mg/capsule)&#xD;
3g tryptophan per day (2 capsules, t.i.d.), at 8AM, 4PM, and 0AM (± 1 hour)</description>
    <arm_group_label>Tryptophan supplement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Maltose</intervention_name>
    <description>Maltose</description>
    <arm_group_label>Maltose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Age: adults &gt;=20 y/o&#xD;
&#xD;
          -  Adults who had night shift schedule &gt;1 month before enrollment, and will have similar&#xD;
             night shift schedule in the following 2 months. (Eligible night shift schedule: &gt;1 day&#xD;
             of evening or night shift in a week)&#xD;
&#xD;
          -  People who will not have plans to travel to another time zone in the following 2-3&#xD;
             months&#xD;
&#xD;
          -  People who will plan to stay in the same job position for the following 3 months&#xD;
&#xD;
          -  People who have no experience in taking tryptophan or melatonin supplement in the past&#xD;
             month&#xD;
&#xD;
          -  Body weight &gt;= 50kg and &lt;=80kg&#xD;
&#xD;
          -  Non-pregnant, non-breastfeeding, not taking contraceptives&#xD;
&#xD;
          -  Not under treatment of steroids, not taking sleeping pills&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  diagnosis of renal or liver diseases&#xD;
&#xD;
          -  diagnosis of Cushing's Disease, Addison's disease&#xD;
&#xD;
          -  psychiatric diagnosis, such as depression and anxiety disorders&#xD;
&#xD;
          -  neurological diseases such as dementia, epilepsy, Parkinson's disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Yang-Ming University</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>March 19, 2021</last_update_submitted>
  <last_update_submitted_qc>March 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Yang Ming University</investigator_affiliation>
    <investigator_full_name>Hsin-Jen Chen</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>tryptophan</keyword>
  <keyword>shift work</keyword>
  <keyword>randomized trial</keyword>
  <keyword>melatonin</keyword>
  <keyword>cortisol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burnout, Psychological</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>
    <ipd_description>The participants did not provide agreement to the researchers.</ipd_description>
  </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/NCT04505800
org study id: YM106114F
nct id: NCT04505800
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This randomized cross-over double-blinded trial aims to investigate the health effect of oral
      l-tryptophan supplementation on workers who rotate night shift work, and to examine the
      influences of different frequencies and timings of supplementation on the health effects.
This study aims to investigate the health effect of oral l-tryptophan supplementation on
      workers who rotate night shift work, and to examine the influences of different frequencies
      and timings of supplementation on the health effects. Night shift work affects melatonin and
      cortisol variation, insomnia, mood issues, and metabolic syndrome. Short-term tryptophan
      supplementation was shown to improve melatonin, sleep quality, and cortisol response to acute
      stress. Little is known whether a longer term of longer-term tryptophan supplementation would
      alleviate the health impacts of night shift work. Nevertheless, melatonin and cortisol have
      their normal circadian patterns. Nothing is known about what temporal structure of tryptophan
      supplement would maximize its health effects on night shift workers melatonin and cortisol
      levels. We will conduct a double-blind cross-over randomized controlled trial to examine the
      benefits of oral tryptophan administration (3g/day, t.i.d.) on night shift workers' health
      outcomes: melatonin and cortisol levels, sleep quality, moods and work performance. We expect
      to reveal the health effect of tryptophan supplementation in night shift workers by using
      sophisticated study design.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Melatonin level in the morning
time frame: 3 weeks
description: Morning (8AM) saliva melatonin level change in the phase
measure: Melatonin level in the afternoon
time frame: 3 weeks
description: Afternoon (4PM) saliva melatonin level change in the phase
measure: Melatonin level at midnight
time frame: 3 weeks
description: Midnight (0AM) saliva melatonin level change in the phase
measure: Cortisol level in the morning
time frame: 3 weeks
description: Morning (8AM) saliva cortisol level change in the phase
measure: Cortisol level in the afternoon
time frame: 3 weeks
description: Afternoon (4PM) saliva cortisol level change in the phase
measure: Cortisol level at midnight
time frame: 3 weeks
description: Midnight (0AM) saliva cortisol level change in the phase
measure: Sleep quality
time frame: 3 weeks
description: Pittsburg Sleep Quality Score (range: 0-21) at the end of the phase. The higher score indicates worse sleep quality
measure: Mood states, depression
time frame: 3 weeks
description: Depression, Anxiety, Stress Scales. Depression score (range 0-42) changes in the phase. The higher score, the more depressed.
measure: Mood states, anxiety
time frame: 3 weeks
description: Depression, Anxiety, Stress Scales. Anxiety score (range 0-42) changes in the phase. The higher score, the more anxious.
measure: Mood states, stress
time frame: 3 weeks
description: Depression, Anxiety, Stress Scales. Stress score (range 0-42) changes in the phase. The higher score, the more stressful.
arm group label: Tryptophan supplement
arm group type: Experimental
description: Pure L-tryptophan in capsules (500mg/capsule)
3g tryptophan per day (2 capsules, t.i.d.), at 8AM, 4PM, and 0AM (± 1 hour)
arm group label: Maltose
arm group type: Placebo Comparator
description: Placebo is maltose powder capsule (500mg/capsule)
3g maltose powder per day (2 capsules, t.i.d.), at 8AM, 4PM, and 0AM (± 1 hour)
intervention type: Dietary Supplement
intervention name: Tryptophan supplement
description: Pure L-tryptophan in capsules (500mg/capsule)
3g tryptophan per day (2 capsules, t.i.d.), at 8AM, 4PM, and 0AM (± 1 hour)
arm group label: Tryptophan supplement
intervention type: Dietary Supplement
intervention name: Maltose
description: Maltose
arm group label: Maltose
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Yang Ming University
investigator full name: Hsin-Jen Chen
investigator title: Associate Professor
mesh term: Burnout, Psychological
mesh term: Tryptophan
sharing ipd: No
ipd description: The participants did not provide agreement to the researchers.