<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/NCT02202629</url>
  </required_header>
  <id_info>
    <org_study_id>PEP-1406</org_study_id>
    <nct_id>NCT02202629</nct_id>
  </id_info>
  <brief_title>Plant Based Extracts and Cognition</brief_title>
  <acronym>CEOPTB</acronym>
  <official_title>The Effects of Different Combinations of Plant Based Extracts on Cognitive Function and Cerebral Blood Flow in Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PepsiCo Global R&amp;D</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PepsiCo Global R&amp;D</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute, randomized, placebo controlled, double blind, 4 arm crossover study to determine the&#xD;
      effect of different combinations of plant based extracts on cognitive function and cerebral&#xD;
      blood flow.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objectives of this study are to assess the effects of oral consumption of three differing&#xD;
      combinations of plant based extracts, on cognitive function and cerebral blood flow (using&#xD;
      Near infrared Spectroscopy) in comparison to placebo. The primary outcome will be change in&#xD;
      cognitive function and mental fatigue during extended performance of the Cognitive Demand&#xD;
      Battery (CDB) at 1, 3 and 6 hours post- consumption.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Anticipated">December 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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in cognitive function and fatigue during extended performance of the Cognitive Demand Battery (CDB) at 1, 3 and 6 hours post consumption Change in long term declarative memory at 1, 3 and 6 hours post-intervention.</measure>
    <time_frame>1-6 hours post intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in executive function at 1, 3 and 6 hours post intervention.</measure>
    <time_frame>1-6 hours post intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cerebral blood flow parameters (oxygenated and deoxygenated haemoglobin levels and their sum) in the frontal cortex during task performance commencing at 1, 3 and 6 hours post-intervention.</measure>
    <time_frame>1-6 hours post intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in episodic memory, as measured by immediate word recall, at 1, 3 and 6 hours post intervention.</measure>
    <time_frame>1-6 hours post intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mood ratings, at 1,3 and 6 hours post intervention.</measure>
    <time_frame>1-6 hours post intervention</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Change in Cognitive Function and Fatigue During Extended Performance of the Cognitive Demand Battery (CDB) at 1, 3 and 6 Hours Post Consumption</condition>
  <condition>Change in Long Term Declarative Memory at 1, 3 and 6 Hours Post-intervention.</condition>
  <arm_group>
    <arm_group_label>Cherry flavoured beverage 1</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>10floz cherry flavoured test article</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cherry flavoured beverage 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10floz of cherry flavoured test article with fruit, vegetable and herbal extracts</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cherry flavoured beverage 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10floz of cherry flavoured test article with fruit, vegetable and herbal extracts</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cherry flavoured beverage 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10floz of cherry flavoured test article with fruit, vegetable and herbal extracts</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Beverage containing plant based extracts</intervention_name>
    <description>Intervention involves single exposure, oral consumption of test article following baseline measurements</description>
    <arm_group_label>Cherry flavoured beverage 2</arm_group_label>
    <arm_group_label>Cherry flavoured beverage 3</arm_group_label>
    <arm_group_label>Cherry flavoured beverage 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Are over 18 or under 49 years of age&#xD;
&#xD;
          -  Self-report of good health&#xD;
&#xD;
          -  Are not excluded on the basis of the following exclusion criteria&#xD;
&#xD;
          -  English is first language (some of the cognitive tests have only been validated in&#xD;
             native English speakers)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are below 18 or above 49 years of age&#xD;
&#xD;
          -  Are a smoker&#xD;
&#xD;
          -  Have food allergies or sensitivities to any of the ingredients contained in the&#xD;
             investigational product or any other foodstuff&#xD;
&#xD;
          -  Currently take medication except the contraceptive pill&#xD;
&#xD;
          -  Have habitually used dietary supplements within the last month (defined as more than 3&#xD;
             consecutive days or 4 days in total)&#xD;
&#xD;
          -  Have sleep disturbances and/or are taking sleep aid medication&#xD;
&#xD;
          -  Have a Body Mass Index (BMI) outside of the range 18-35 kg/m2&#xD;
&#xD;
          -  Have high blood pressure (systolic over 139 mm Hg or diastolic over 89 mm Hg)&#xD;
&#xD;
          -  Have a history of neurological, vascular or psychiatric illness including epilepsy or&#xD;
             seizures (excluding depressive illness and anxiety)&#xD;
&#xD;
          -  Have a current diagnosis of anxiety or depression&#xD;
&#xD;
          -  Are pregnant, trying to get pregnant or breast feeding&#xD;
&#xD;
          -  Have a recent history of (within 12 months of screening visit) or strong potential for&#xD;
             alcohol or substance abuse. Alcohol abuse is defined as more than 60g (men) / 40g&#xD;
             (women) pure alcohol per day (7 / 5.5 units)&#xD;
&#xD;
          -  Are (or are seeking to become) pregnant or are lactating&#xD;
&#xD;
          -  Have learning difficulties, dyslexia or colour blindness&#xD;
&#xD;
          -  Have visual impairment that cannot be corrected with glasses or contact lenses&#xD;
&#xD;
          -  Have frequent migraines that require medication (more than or equal to 1 per month)&#xD;
&#xD;
          -  Have disorders of the blood&#xD;
&#xD;
          -  Have a heart disorder or a history of vascular illness&#xD;
&#xD;
          -  Have a respiratory disorder that requires regular medication (Note: participants with&#xD;
             asthma who only take their medication occasionally/as required are eligible for this&#xD;
             study)&#xD;
&#xD;
          -  Have type I or type II diabetes&#xD;
&#xD;
          -  Have a history of renal or hepatic disease, or other severe diseases of the&#xD;
             gastrointestinal tract (e.g. iron accumulation, iron utilization disorders,&#xD;
             hypercalcaemia, hypercalciuria), that are likely to interfere with&#xD;
             metabolism/absorption/secretion of the product under investigation&#xD;
&#xD;
          -  Have any health condition that would prevent fulfillment of the study requirements&#xD;
&#xD;
          -  Are currently or have in the past 4 weeks participated in other clinical or nutrition&#xD;
             intervention studies&#xD;
&#xD;
          -  Do not have a bank account (required for payment)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>David Kennedy, PhD</last_name>
    <email>david.kennedy@northumbria.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Philippa Jackson</last_name>
    <email>philippa.jackson@northumbria.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Northumbria University</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <zip>NE1 8ST</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>July 28, 2014</last_update_submitted>
  <last_update_submitted_qc>July 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02202629
org study id: PEP-1406
nct id: NCT02202629
lead sponsor: 
has dmc: No
Acute, randomized, placebo controlled, double blind, 4 arm crossover study to determine the
      effect of different combinations of plant based extracts on cognitive function and cerebral
      blood flow.
The objectives of this study are to assess the effects of oral consumption of three differing
      combinations of plant based extracts, on cognitive function and cerebral blood flow (using
      Near infrared Spectroscopy) in comparison to placebo. The primary outcome will be change in
      cognitive function and mental fatigue during extended performance of the Cognitive Demand
      Battery (CDB) at 1, 3 and 6 hours post- consumption.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Change in cognitive function and fatigue during extended performance of the Cognitive Demand Battery (CDB) at 1, 3 and 6 hours post consumption Change in long term declarative memory at 1, 3 and 6 hours post-intervention.
time frame: 1-6 hours post intervention
measure: Change in executive function at 1, 3 and 6 hours post intervention.
time frame: 1-6 hours post intervention
measure: Change in cerebral blood flow parameters (oxygenated and deoxygenated haemoglobin levels and their sum) in the frontal cortex during task performance commencing at 1, 3 and 6 hours post-intervention.
time frame: 1-6 hours post intervention
measure: Change in episodic memory, as measured by immediate word recall, at 1, 3 and 6 hours post intervention.
time frame: 1-6 hours post intervention
measure: Change in mood ratings, at 1,3 and 6 hours post intervention.
time frame: 1-6 hours post intervention
arm group label: Cherry flavoured beverage 1
arm group type: Placebo Comparator
description: 10floz cherry flavoured test article
arm group label: Cherry flavoured beverage 2
arm group type: Experimental
description: 10floz of cherry flavoured test article with fruit, vegetable and herbal extracts
arm group label: Cherry flavoured beverage 3
arm group type: Experimental
description: 10floz of cherry flavoured test article with fruit, vegetable and herbal extracts
arm group label: Cherry flavoured beverage 4
arm group type: Experimental
description: 10floz of cherry flavoured test article with fruit, vegetable and herbal extracts
intervention type: Other
intervention name: Beverage containing plant based extracts
description: Intervention involves single exposure, oral consumption of test article following baseline measurements
arm group label: Cherry flavoured beverage 2
arm group label: Cherry flavoured beverage 3
arm group label: Cherry flavoured beverage 4
criteria: 
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David Kennedy, PhD
email: david.kennedy@northumbria.ac.uk
last name: Philippa Jackson
email: philippa.jackson@northumbria.ac.uk
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Fatigue