<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/NCT02187328</url>
  </required_header>
  <id_info>
    <org_study_id>Ben-0614a</org_study_id>
    <nct_id>NCT02187328</nct_id>
  </id_info>
  <brief_title>Effects of Fruit Juices on Hormone Metabolism</brief_title>
  <official_title>Effect of Grapefruit Juice and Exercise 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>
      The purpose of this study is to determine whether grapefruit juice alters the metabolism of&#xD;
      cortisol following intense exercise.&#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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma cortisol change from baseline at 45 minutes</measure>
    <time_frame>Baseline, 45 minutes</time_frame>
    <description>Plasma cortisol levels will be collected at baseline and 45 minutes post-exercise for the Grapefruit visit intervention and for the Apple juice intervention. The interventions are acute ( 1 day), 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 14 to 30 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in plasma cortisol from 15 minutes to baseline</measure>
    <time_frame>baseline, 15 minutes</time_frame>
    <description>Plasma cortisol levels will be collected at baseline and 15 minutes post-exercise for the Grapefruit visit intervention and for the Apple juice intervention. The interventions are acute ( 1 day), 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 14 to 30 days.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Cortisol</condition>
  <arm_group>
    <arm_group_label>Grapefruit juice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12.5 OZ Grapefruit juice: Subject will ingest grapefruit juice 12.5 OZ twice on the day of their scheduled laboratory visit. Once in the morning and once in the afternoon prior to their evening visit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Apple juice</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>10.5 OZ Apple juice: Subject will ingest apple juice 10.5 OZ twice on the day of their scheduled laboratory visit. Once in the morning and once in the afternoon 3 hours prior to their evening visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Grapefruit juice</intervention_name>
    <description>Volunteers participate in two visits at least 5 days apart. The day of their visit they ingest 12.5 oz of grapefruit juice in the morning and 12.5 oz of grapefruit juice ingested in the afternoon, 3h before reporting to the laboratory. The order of the visits is randomized, one visit volunteers ingest apple juice only, the other visit grapefruit juice only</description>
    <arm_group_label>Grapefruit juice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Apple juice</intervention_name>
    <description>Volunteers participate in two visits at least 5 days apart. The day of their visit they ingest 12.5 oz of grapefruit juice or Apple juice ingested in the morning and 12.5 oz of grapefruit juice ingested in the afternoon, 3h before reporting to the laboratory. The order of the visits is randomized, one visit volunteers ingest apple juice only, the other visit grapefruit juice only</description>
    <arm_group_label>Apple juice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Young men and women, not taking medications known to alter glucocorticoid metabolism&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes, uncontrolled hypertension, obesity, any medication known to interact with&#xD;
             grapefruit juice&#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>
    <contact>
      <last_name>Meagan P Daniels</last_name>
      <email>madaniel@ben.edu</email>
    </contact>
    <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/NCT02187328
org study id: Ben-0614a
nct id: NCT02187328
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether grapefruit juice alters the metabolism of
      cortisol following intense exercise.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Plasma cortisol change from baseline at 45 minutes
time frame: Baseline, 45 minutes
description: Plasma cortisol levels will be collected at baseline and 45 minutes post-exercise for the Grapefruit visit intervention and for the Apple juice intervention. The interventions are acute ( 1 day), 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 14 to 30 days.
measure: Change in plasma cortisol from 15 minutes to baseline
time frame: baseline, 15 minutes
description: Plasma cortisol levels will be collected at baseline and 15 minutes post-exercise for the Grapefruit visit intervention and for the Apple juice intervention. The interventions are acute ( 1 day), 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 14 to 30 days.
arm group label: Grapefruit juice
arm group type: Experimental
description: 12.5 OZ Grapefruit juice: Subject will ingest grapefruit juice 12.5 OZ twice on the day of their scheduled laboratory visit. Once in the morning and once in the afternoon prior to their evening visit
arm group label: Apple juice
arm group type: Placebo Comparator
description: 10.5 OZ Apple juice: Subject will ingest apple juice 10.5 OZ twice on the day of their scheduled laboratory visit. Once in the morning and once in the afternoon 3 hours prior to their evening visit.
intervention type: Other
intervention name: Grapefruit juice
description: Volunteers participate in two visits at least 5 days apart. The day of their visit they ingest 12.5 oz of grapefruit juice in the morning and 12.5 oz of grapefruit juice ingested in the afternoon, 3h before reporting to the laboratory. The order of the visits is randomized, one visit volunteers ingest apple juice only, the other visit grapefruit juice only
arm group label: Grapefruit juice
intervention type: Other
intervention name: Apple juice
description: Volunteers participate in two visits at least 5 days apart. The day of their visit they ingest 12.5 oz of grapefruit juice or Apple juice ingested in the morning and 12.5 oz of grapefruit juice ingested in the afternoon, 3h before reporting to the laboratory. The order of the visits is randomized, one visit volunteers ingest apple juice only, the other visit grapefruit juice only
arm group label: Apple juice
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
contact: 
investigator: 
country: United States
responsible party type: Sponsor