<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/NCT01669317</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC 12004</org_study_id>
    <nct_id>NCT01669317</nct_id>
  </id_info>
  <brief_title>Mechanisms Underlying the Sleep Promoting Effect of Cherry Juice Standardized to Its Proanthocyanidin Content</brief_title>
  <acronym>CHERRY JUICE</acronym>
  <official_title>Mechanisms Underlying the Sleep Promoting Effect of Cherry Juice Standardized to Its Proanthocyanidin Content</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cherry Grower's Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pennington Biomedical Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to demonstrate that cherry juice is effective in treating insomnia,&#xD;
      and to show that it works by inhibiting an enzyme that will be measured in the blood.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will consist of 4 visits - 1 screening visit and 3 treatment visits. Screening&#xD;
      visit will consist of a fasting chemistry panel, a health questionnaire, an Insomnia Severity&#xD;
      Index, the Epworth Sleepiness Scale, the Pittsburgh Sleep Quality Index, the Beck Depression&#xD;
      Inventory, the State-Trait Anxiety Inventory, and the Fatigue Severity Scale.&#xD;
&#xD;
      Ten subjects passing screening will take for 2 weeks between dinner and bedtime in a blinded&#xD;
      and balanced order: 1. Eight ounces of cherry juice standardized to its proanthocyanidin&#xD;
      content in the morning and 8 ounces of cherry juice standardized to its procyanidin content&#xD;
      1-2 hours before bedtime for 14 days; 2. A similar amount of placebo juice with the same&#xD;
      timing for the cross-over. There will be a 2-week washout between each of the treatment&#xD;
      periods. Subjects will be scheduled for two overnight PSGs, one at the end of each two-week&#xD;
      treatment period. On the morning following each test the insomnia severity index and other&#xD;
      questionnaires will be repeated. The order of the placebo juice and cherry juice will be&#xD;
      random and balanced.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">September 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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compare the polysomnography of participants with insomnia</measure>
    <time_frame>Baseline and Week 4</time_frame>
    <description>Compare the polysomnography of participants with insomnia on a night at the end of 2 weeks taking: Eight ounces of standardized cherry juice vs. the night taking the placebo juice.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare the Insomnia Severity Index and validated questionnaires</measure>
    <time_frame>Baseline and Week 4</time_frame>
    <description>Compare the Insomnia Severity Index, a validated questionnaire, in participants with insomnia on a night at the end of 2 weeks taking: 1. Eight ounces of cherry juice standardized to its proanthocyanidin content in the morning, and 1-2 hours before bedtime; 2. Eight ounces of an identical appearing placebo in the morning and 1-2 hours before bedtime.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of insomnia sleep scales</measure>
    <time_frame>Baseline and Week 4</time_frame>
    <description>Compare five different sleep quality scales with insomnia on a night at the end of 2 weeks taking: 1. An 8-ounce glass of cherry juice standardized to its proanthocyanidin content in the morning and 1-2 hours before bedtime; 2. an 8- ounce glass of an identical appearing placebo in the morning and 1-2 hours before bedtime.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in the enzyme blood test</measure>
    <time_frame>Baseline, Week 2 &amp; Week 4</time_frame>
    <description>compare the expression of enzyme blood test of participants taking the standardized cherry juice vs. the the placebo juice.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Insomnia</condition>
  <condition>Sleep Problem</condition>
  <arm_group>
    <arm_group_label>Cherry Juice Standardized</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>You will be given an 8-ounce glass of cherry juice to drink when you arrive at the Sleep Laboratory.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Artificial Cherry Juice</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>You will be given an 8-ounce glass of artificial cherry juice to drink when you arrive at the Sleep Laboratory.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>8-ounce glass of cherry juice</intervention_name>
    <description>You will be given an 8-ounce glass of cherry juice or artificial cherry juice to drink when you arrive at the Sleep Laboratory.</description>
    <arm_group_label>Artificial Cherry Juice</arm_group_label>
    <arm_group_label>Cherry Juice Standardized</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Artificial Cherry Juice</intervention_name>
    <description>You will be given an 8-ounce glass of artificial cherry juice</description>
    <arm_group_label>Artificial Cherry Juice</arm_group_label>
    <arm_group_label>Cherry Juice Standardized</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female with a usual bedtime between 9 pm and midnight.&#xD;
&#xD;
          -  65 years of age or older.&#xD;
&#xD;
          -  Sleep problem &gt;3 nights per week, meeting the International Classification of Sleep&#xD;
             Disorders (ICSD-2*) diagnostic criteria of insomnia for at least 6 months.&#xD;
&#xD;
          -  An insomnia severity index ≥ 10 and a minimum of 30 minutes of either sleep-onset&#xD;
             latency (SL) or wake after sleep onset (WASO).&#xD;
&#xD;
             *ICSD-2 general criteria for insomnia:&#xD;
&#xD;
          -  A complaint of difficulty initiating sleep, difficulty maintaining sleep, or waking up&#xD;
             too early, or sleep that is chronically non-restorative or poor in quality.&#xD;
&#xD;
          -  The above sleep difficulty occurs despite adequate opportunity and circumstances for&#xD;
             sleep.&#xD;
&#xD;
          -  At least one of the following forms of daytime impairment related to the nighttime&#xD;
             sleep difficulty is reported by the patient:&#xD;
&#xD;
          -  Fatigue or malaise.&#xD;
&#xD;
          -  Attention, concentration, or memory impairment.&#xD;
&#xD;
          -  Social or vocational dysfunction or poor school performance.&#xD;
&#xD;
          -  Mood disturbance or irritability.&#xD;
&#xD;
          -  Daytime sleepiness.&#xD;
&#xD;
          -  Motivation, energy, or initiative reduction.&#xD;
&#xD;
          -  Proneness for errors or accidents at work or while driving.&#xD;
&#xD;
          -  Tension, headaches, or gastrointestinal symptoms in response to sleep loss.&#xD;
&#xD;
          -  Concerns or worries about sleep.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes.&#xD;
&#xD;
          -  Sedating or hypnotic medications.&#xD;
&#xD;
          -  Any chronic medication that has not had a stable dose for 1 month or longer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frank Greenway, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Study Principal Investigator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pennington Biomedical Research Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>December 17, 2015</last_update_submitted>
  <last_update_submitted_qc>December 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pennington Biomedical Research Center</investigator_affiliation>
    <investigator_full_name>Frank Greenway</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Cherry Juice Pilot</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Parasomnias</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/NCT01669317
org study id: PBRC 12004
nct id: NCT01669317
lead sponsor: 
collaborator: 
has dmc: No
This study is designed to demonstrate that cherry juice is effective in treating insomnia,
      and to show that it works by inhibiting an enzyme that will be measured in the blood.
This study will consist of 4 visits - 1 screening visit and 3 treatment visits. Screening
      visit will consist of a fasting chemistry panel, a health questionnaire, an Insomnia Severity
      Index, the Epworth Sleepiness Scale, the Pittsburgh Sleep Quality Index, the Beck Depression
      Inventory, the State-Trait Anxiety Inventory, and the Fatigue Severity Scale.

      Ten subjects passing screening will take for 2 weeks between dinner and bedtime in a blinded
      and balanced order: 1. Eight ounces of cherry juice standardized to its proanthocyanidin
      content in the morning and 8 ounces of cherry juice standardized to its procyanidin content
      1-2 hours before bedtime for 14 days; 2. A similar amount of placebo juice with the same
      timing for the cross-over. There will be a 2-week washout between each of the treatment
      periods. Subjects will be scheduled for two overnight PSGs, one at the end of each two-week
      treatment period. On the morning following each test the insomnia severity index and other
      questionnaires will be repeated. The order of the placebo juice and cherry juice will be
      random and balanced.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Compare the polysomnography of participants with insomnia
time frame: Baseline and Week 4
description: Compare the polysomnography of participants with insomnia on a night at the end of 2 weeks taking: Eight ounces of standardized cherry juice vs. the night taking the placebo juice.
measure: Compare the Insomnia Severity Index and validated questionnaires
time frame: Baseline and Week 4
description: Compare the Insomnia Severity Index, a validated questionnaire, in participants with insomnia on a night at the end of 2 weeks taking: 1. Eight ounces of cherry juice standardized to its proanthocyanidin content in the morning, and 1-2 hours before bedtime; 2. Eight ounces of an identical appearing placebo in the morning and 1-2 hours before bedtime.
measure: Comparison of insomnia sleep scales
time frame: Baseline and Week 4
description: Compare five different sleep quality scales with insomnia on a night at the end of 2 weeks taking: 1. An 8-ounce glass of cherry juice standardized to its proanthocyanidin content in the morning and 1-2 hours before bedtime; 2. an 8- ounce glass of an identical appearing placebo in the morning and 1-2 hours before bedtime.
measure: Differences in the enzyme blood test
time frame: Baseline, Week 2 & Week 4
description: compare the expression of enzyme blood test of participants taking the standardized cherry juice vs. the the placebo juice.
arm group label: Cherry Juice Standardized
arm group type: Experimental
description: You will be given an 8-ounce glass of cherry juice to drink when you arrive at the Sleep Laboratory.
arm group label: Artificial Cherry Juice
arm group type: Placebo Comparator
description: You will be given an 8-ounce glass of artificial cherry juice to drink when you arrive at the Sleep Laboratory.
intervention type: Other
intervention name: 8-ounce glass of cherry juice
description: You will be given an 8-ounce glass of cherry juice or artificial cherry juice to drink when you arrive at the Sleep Laboratory.
arm group label: Artificial Cherry Juice
arm group label: Cherry Juice Standardized
intervention type: Other
intervention name: Artificial Cherry Juice
description: You will be given an 8-ounce glass of artificial cherry juice
arm group label: Artificial Cherry Juice
arm group label: Cherry Juice Standardized
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Frank Greenway, MD
role: Principal Investigator
affiliation: Study Principal Investigator
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: Frank Greenway
investigator title: Principal Investigator
mesh term: Dyssomnias
mesh term: Parasomnias