<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/NCT02209103</url>
  </required_header>
  <id_info>
    <org_study_id>NL43845.068.13</org_study_id>
    <nct_id>NCT02209103</nct_id>
  </id_info>
  <brief_title>The Sleep Improving Effects of Orange Phenolics</brief_title>
  <official_title>Determination of the Sleep Improving Effects of Phenolics From an Orange Peel Extract</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to determine whether a citrus flavonoid or a citrus flavonoid formulation can&#xD;
      improve objective sleep duration and/or quality, and/or improve perceived sleep quality and&#xD;
      feelings of rest.&#xD;
&#xD;
      Participants will complete a total of 9 test nights, which consist of sleeping with the sleep&#xD;
      monitoring system after ingestion of the test product or a placebo, and filling out&#xD;
      sleep-related questionnaires.&#xD;
&#xD;
      The study has a crossover design, meaning that all participants receive all three&#xD;
      interventions (citrus flavonoid, citrus flavonoid formulation, placebo) three times, in a&#xD;
      randomized order.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep quality as assessed objectively by means of a portable sleep monitoring system (ZEO)</measure>
    <time_frame>9 test nights (up to 9 days)</time_frame>
    <description>• The primary endpoint for this study is the determination of sleep quality, as assessed objectively with the portable sleep monitoring system ZEO, which is based on EEG/EMG (electromyography) coupled with an automatic sleep phase classifier. Sleep stages are classified as deep sleep, light sleep, REM (rapid eye movement) sleep or awake. The sleep patterns of the participants after ingestion of the two different test products will be compared to each other and to placebo.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective sleep quality ratings and fitness, tiredness and cognitive ratings, obtained from questionnaires</measure>
    <time_frame>up to 9 days. Questionnaires are filled out the morning after every test night</time_frame>
    <description>Leeds Sleep Evaluation Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">77</enrollment>
  <condition>Polyphenols</condition>
  <condition>Sleep</condition>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>Citrus flavonoid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Citrus flavonoid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Citrus flavonoid formulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Citrus flavonoid formulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lozenge containing citrus flavonoid</intervention_name>
    <arm_group_label>Citrus flavonoid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lozenge containing citrus flavonoid formulation</intervention_name>
    <arm_group_label>Citrus flavonoid formulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Identical looking placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-75&#xD;
&#xD;
          -  Non-smoking&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  Lightly disturbed sleep for at least six months, on a regular basis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe sleep disorders (sleep apnea, restless legs syndrome)&#xD;
&#xD;
          -  An apparent cause for the sleep disorders (pain, etc.)&#xD;
&#xD;
          -  Clinically significant abnormal liver functioning&#xD;
&#xD;
          -  Clinically significant abnormal serum creatinine&#xD;
&#xD;
          -  BMI lower than 18 or higher than 30 kg/m2&#xD;
&#xD;
          -  Use of concomitant medications or supplements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chris Van der Grinten</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department: lung diseases MUMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maastricht University Medical Center (MUMC)</name>
      <address>
        <city>Maastricht</city>
        <zip>6229</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>November 19, 2015</last_update_submitted>
  <last_update_submitted_qc>November 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Polyphenols</keyword>
  <keyword>Orange</keyword>
  <keyword>Sleep</keyword>
  <keyword>Fatigue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <!-- 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/NCT02209103
org study id: NL43845.068.13
nct id: NCT02209103
lead sponsor: 
has dmc: Yes
This study aims to determine whether a citrus flavonoid or a citrus flavonoid formulation can
      improve objective sleep duration and/or quality, and/or improve perceived sleep quality and
      feelings of rest.

      Participants will complete a total of 9 test nights, which consist of sleeping with the sleep
      monitoring system after ingestion of the test product or a placebo, and filling out
      sleep-related questionnaires.

      The study has a crossover design, meaning that all participants receive all three
      interventions (citrus flavonoid, citrus flavonoid formulation, placebo) three times, in a
      randomized order.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Sleep quality as assessed objectively by means of a portable sleep monitoring system (ZEO)
time frame: 9 test nights (up to 9 days)
description: • The primary endpoint for this study is the determination of sleep quality, as assessed objectively with the portable sleep monitoring system ZEO, which is based on EEG/EMG (electromyography) coupled with an automatic sleep phase classifier. Sleep stages are classified as deep sleep, light sleep, REM (rapid eye movement) sleep or awake. The sleep patterns of the participants after ingestion of the two different test products will be compared to each other and to placebo.
measure: Subjective sleep quality ratings and fitness, tiredness and cognitive ratings, obtained from questionnaires
time frame: up to 9 days. Questionnaires are filled out the morning after every test night
description: Leeds Sleep Evaluation Questionnaire
arm group label: Citrus flavonoid
arm group type: Experimental
description: Citrus flavonoid
arm group label: Citrus flavonoid formulation
arm group type: Experimental
description: Citrus flavonoid formulation
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Dietary Supplement
intervention name: Lozenge containing citrus flavonoid
arm group label: Citrus flavonoid
intervention type: Dietary Supplement
intervention name: Lozenge containing citrus flavonoid formulation
arm group label: Citrus flavonoid formulation
intervention type: Dietary Supplement
intervention name: Identical looking placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Chris Van der Grinten
role: Principal Investigator
affiliation: Department: lung diseases MUMC
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Fatigue