<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/NCT02187341</url>
  </required_header>
  <id_info>
    <org_study_id>Ben-0614b</org_study_id>
    <nct_id>NCT02187341</nct_id>
  </id_info>
  <brief_title>Effects of Exercise and 5-HTP on Cortisol Levels</brief_title>
  <official_title>Effects of Exercise and 5-HTP on Cortisol Levels</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Benedictine University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Benedictine University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It has been shown that 5-HTP stimulates cortisol levels in plasma and saliva. Similarly, it&#xD;
      has been shown that intense exercise stimulates an increase in plasma and salivary cortisol&#xD;
      levels. The purpose of this study is to examine the combined effects of 5-HTP + intense&#xD;
      exercise on plasma and salivary cortisol levels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in plasma cortisol from baseline to 20 minutes post</measure>
    <time_frame>baseline, 20 min</time_frame>
    <description>Plasma cortisol will be assessed at baseline and 20 min post exercise and compared to baseline, and compared between treatments: 5-HTP vs placebo visit. The interventions are acute ( 1 dose, 1 day), for 5-HTP and for placebo, there is no follow up. The interventions are at least 1 week apart. For a given subject, the estimated time for study completion for the 2 treatments is 10 to 30 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in plasma cortisol from baseline to 5 minutes post</measure>
    <time_frame>baseline, 5 minutes</time_frame>
    <description>Plasma cortisol will be assessed at baseline and 5 min post exercise and compared to baseline, and compared between treatments: 5-HTP vs placebo visit. The interventions are acute ( 1 dose, 1 day), for 5-HTP and for placebo, there is no follow up. The interventions are at least 1 week apart. For a given subject, the estimated time for study completion for the 2 treatments is 10 to 30 days</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Plasma Cortisol</condition>
  <arm_group>
    <arm_group_label>5-HTP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>200 mg 5-HTP capsule will be ingested 2h prior to reporting to the laboratory.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>For these visit subjects will ingest placebo (Sugar pill) capsule 2 hours before reporting to the laboratory.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>5-HTP</intervention_name>
    <description>Volunteers participate in two visits at least 5 days apart . The day of their visit they ingest (2 hours before reporting to the laboratory) either a capsule containing 200 mg of 5-HTP or a capsule containing placebo (sugar pill). The order of the visits is randomized</description>
    <arm_group_label>5-HTP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Volunteers participate in two visits at least 5 days apart . The day of their visit they ingest (2 hours before reporting to the laboratory) either a capsule containing 200 mg of 5-HTP or a capsule containing placebo (sugar pill). The order of the visits is randomized</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy men and women, not taking medication known to alter glucocorticoid metabolism&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Obesity&#xD;
&#xD;
          -  Hypertension&#xD;
&#xD;
          -  Coronary artery disease&#xD;
&#xD;
          -  Psychiatric disorders&#xD;
&#xD;
          -  Any disease preventing them from participating in intense exercise&#xD;
&#xD;
          -  Subjects taking medication known to interfere with glucocorticoid metabolism will be&#xD;
             excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pedro Del Corral, PhD-MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Benedictine University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pedro Del Corral, PhD-MD</last_name>
    <phone>630 8296575</phone>
    <email>pdelcorral@ben.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Benedictine University</name>
      <address>
        <city>Lisle</city>
        <state>Illinois</state>
        <zip>60532</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Pedro Del Corral, PhD-MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 10, 2014</last_update_submitted>
  <last_update_submitted_qc>July 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02187341
org study id: Ben-0614b
nct id: NCT02187341
lead sponsor: 
has dmc: No
It has been shown that 5-HTP stimulates cortisol levels in plasma and saliva. Similarly, it
      has been shown that intense exercise stimulates an increase in plasma and salivary cortisol
      levels. The purpose of this study is to examine the combined effects of 5-HTP + intense
      exercise on plasma and salivary cortisol levels.
allocation: Randomized
intervention model: Crossover Assignment
masking: Double (Participant, Investigator)
measure: Change in plasma cortisol from baseline to 20 minutes post
time frame: baseline, 20 min
description: Plasma cortisol will be assessed at baseline and 20 min post exercise and compared to baseline, and compared between treatments: 5-HTP vs placebo visit. The interventions are acute ( 1 dose, 1 day), for 5-HTP and for placebo, there is no follow up. The interventions are at least 1 week apart. For a given subject, the estimated time for study completion for the 2 treatments is 10 to 30 days
measure: Change in plasma cortisol from baseline to 5 minutes post
time frame: baseline, 5 minutes
description: Plasma cortisol will be assessed at baseline and 5 min post exercise and compared to baseline, and compared between treatments: 5-HTP vs placebo visit. The interventions are acute ( 1 dose, 1 day), for 5-HTP and for placebo, there is no follow up. The interventions are at least 1 week apart. For a given subject, the estimated time for study completion for the 2 treatments is 10 to 30 days
arm group label: 5-HTP
arm group type: Experimental
description: 200 mg 5-HTP capsule will be ingested 2h prior to reporting to the laboratory.
arm group label: Placebo
arm group type: Placebo Comparator
description: For these visit subjects will ingest placebo (Sugar pill) capsule 2 hours before reporting to the laboratory.
intervention type: Dietary Supplement
intervention name: 5-HTP
description: Volunteers participate in two visits at least 5 days apart . The day of their visit they ingest (2 hours before reporting to the laboratory) either a capsule containing 200 mg of 5-HTP or a capsule containing placebo (sugar pill). The order of the visits is randomized
arm group label: 5-HTP
intervention type: Dietary Supplement
intervention name: Placebo
description: Volunteers participate in two visits at least 5 days apart . The day of their visit they ingest (2 hours before reporting to the laboratory) either a capsule containing 200 mg of 5-HTP or a capsule containing placebo (sugar pill). The order of the visits is randomized
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pedro Del Corral, PhD-MD
role: Principal Investigator
affiliation: Benedictine University
last name: Pedro Del Corral, PhD-MD
phone: 630 8296575
email: pdelcorral@ben.edu
facility: 
status: Recruiting
investigator: 
country: United States
responsible party type: Sponsor