<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/NCT02264561</url>
  </required_header>
  <id_info>
    <org_study_id>14.12.NRC</org_study_id>
    <nct_id>NCT02264561</nct_id>
  </id_info>
  <brief_title>Caffeine's Effect on Attention</brief_title>
  <official_title>The Effect of Caffeine on Attention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Société des Produits Nestlé (SPN)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether caffeine improves attention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Single centre single dose cross-over, placebo-controlled, double blind, randomized trial with&#xD;
      two treatment conditions : caffeine and placebo&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">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>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Attention test: milliseconds and index of stimulus sensitivity</measure>
    <time_frame>duration 10 days from screening to last visit (V2)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Central Nervous System :response time.</measure>
    <time_frame>duration: 10 days from screening to last visit (V2)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood measures: Visual Analog scale.</measure>
    <time_frame>duration 10 days from screening to last visit V2</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Attention</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Mannitol administered at visit 1 and at visit 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>caffeine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>caffeine administered at visit 1 and at visit 2</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Food</intervention_name>
    <description>Active group</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>caffeine</arm_group_label>
    <other_name>Caffeine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Food</intervention_name>
    <description>Control group</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>caffeine</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Healthy male and female Aged 40-60 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Center for Human Drug Research</name>
      <address>
        <city>Leiden</city>
        <state>CL</state>
        <zip>2333</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>April 7, 2015</last_update_submitted>
  <last_update_submitted_qc>April 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Caffeine</mesh_term>
  </intervention_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/NCT02264561
org study id: 14.12.NRC
nct id: NCT02264561
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether caffeine improves attention.
Single centre single dose cross-over, placebo-controlled, double blind, randomized trial with
      two treatment conditions : caffeine and placebo
allocation: Randomized
intervention model: Crossover Assignment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Attention test: milliseconds and index of stimulus sensitivity
time frame: duration 10 days from screening to last visit (V2)
measure: Central Nervous System :response time.
time frame: duration: 10 days from screening to last visit (V2)
measure: Mood measures: Visual Analog scale.
time frame: duration 10 days from screening to last visit V2
arm group label: Placebo
arm group type: Placebo Comparator
description: Mannitol administered at visit 1 and at visit 2
arm group label: caffeine
arm group type: Active Comparator
description: caffeine administered at visit 1 and at visit 2
intervention type: Other
intervention name: Food
description: Active group
arm group label: Placebo
arm group label: caffeine
other name: Caffeine
intervention type: Other
intervention name: Food
description: Control group
arm group label: Placebo
arm group label: caffeine
other name: Placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Caffeine