<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/NCT03278743</url>
  </required_header>
  <id_info>
    <org_study_id>UNewcastle</org_study_id>
    <nct_id>NCT03278743</nct_id>
  </id_info>
  <brief_title>Tea Consumption and Cognitive Performance in the Very Old</brief_title>
  <official_title>Higher Tea Consumption is Associated With Better Performance on Measures of Attention and Psychomotor Speed in the Very Old: The Newcastle 85+ Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Newcastle University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Newcastle University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Studies have found a beneficial effect of tea consumption on the reduction of risk of&#xD;
      cognitive impairment and dementia in older aged populations. However, there is a paucity of&#xD;
      data on these associations in the very old defined as individuals aged 85 years and over.&#xD;
      Therefore, we hypothesized that higher tea consumption was associated with better global and&#xD;
      domain-specific cognitive function. We investigated the relationship between tea consumption&#xD;
      in the very old and measures of global cognitive function, memory, attention and psychomotor&#xD;
      speed.&#xD;
&#xD;
      The Newcastle 85+ Study was a longitudinal (5-years), population-based cohort study of&#xD;
      individuals aged 85+ years in North East England, United Kingdom. The final sample included&#xD;
      676 community-dwelling and institutionalized men and women recruited through general medical&#xD;
      practices.&#xD;
&#xD;
      Baseline tea consumption was assessed through a 2x24-hr multiple pass recall and longitudinal&#xD;
      measures of global and domain specific (memory, speed and attention) cognitive function&#xD;
      through the standardized mini-mental state examination and the cognitive drug research&#xD;
      system. Linear mixed models, controlling for demographic (e.g. age, sex and education) and&#xD;
      health variables were used to determine whether tea consumption was protective against&#xD;
      cognitive decline.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2006</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Standardized mini-mental state examination</measure>
    <time_frame>Baseline</time_frame>
    <description>Measure of global cognition (Score 0-30)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of decline of the standardized mini-mental state examination</measure>
    <time_frame>Baseline to 5 years follow-up</time_frame>
    <description>Measure of global cognition (Score 0-30)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Simple reaction time</measure>
    <time_frame>Baseline</time_frame>
    <description>Simple reaction time assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box. The participant is instructed to press &quot;YES&quot; as quickly as possible every time the word &quot;YES&quot; is presented on the screen. In total, 30 &quot;YES&quot; stimuli are presented with varying inter-stimulus interval. (ms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of reaction speed decline</measure>
    <time_frame>Baseline to 3 years follow-up</time_frame>
    <description>Simple reaction time assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box.The participant is instructed to press &quot;YES&quot; as quickly as possible every time the word &quot;YES&quot; is presented on the screen. In total, 30 &quot;YES&quot; stimuli are presented with varying inter-stimulus interval. (ms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Choice reaction time</measure>
    <time_frame>Baseline</time_frame>
    <description>Choice reaction time assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box. Either the word &quot;YES&quot; or &quot;NO&quot; is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible. There are 30 trials for each stimulus word, which is chosen randomly with equal probability, with varying inter-stimulus interval. (ms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of reaction choice decline</measure>
    <time_frame>Baseline to 3 years follow-up</time_frame>
    <description>Choice reaction time assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box.Either the word &quot;YES&quot; or &quot;NO&quot; is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible. There are 30 trials for each stimulus word, which is chosen randomly with equal probability, with varying inter-stimulus interval. (ms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digit vigilance task</measure>
    <time_frame>Baseline</time_frame>
    <description>Digit vigilance task assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box. Target digit is randomly selected and constantly displayed to the right of the screen. A series of digits (0-9) are presented in the centre of the screen at the rate of 150 per minute. The participant is required to press the &quot;YES&quot; button as quickly as possible every time the digit in the series matches the target digit. There are 300 digits in the series and the task lasts for 2 minutes. (ms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of digit vigilance task decline</measure>
    <time_frame>Baseline to 3 years follow-up</time_frame>
    <description>Digit vigilance task assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box. Target digit is randomly selected and constantly displayed to the right of the screen. A series of digits (0-9) are presented in the centre of the screen at the rate of 150 per minute. The participant is required to press the &quot;YES&quot; button as quickly as possible every time the digit in the series matches the target digit. There are 300 digits in the series and the task lasts for 2 minutes. (ms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Word recognition</measure>
    <time_frame>Baseline</time_frame>
    <description>Word recognition was assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box. A list of words is presented on screen for the subject to remember. Immediately after the presentation the subject is asked to recall as many words as possible. 20 minutes later, the same list of words is presented with added distracter words. For each word, the subject is asked to indicate whether or not it belongs o the original list by pressing 'YES' or 'NO'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of word recognition decline</measure>
    <time_frame>Baseline to 3 years follow-up</time_frame>
    <description>Word recognition was assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box.A list of words is presented on screen for the subject to remember. Immediately after the presentation the subject is asked to recall as many words as possible. 20 minutes later, the same list of words is presented with added distracter words. For each word, the subject is asked to indicate whether or not it belongs to the original list by pressing 'YES' or 'NO'.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1042</enrollment>
  <condition>Cognition</condition>
  <arm_group>
    <arm_group_label>low to moderate tea consumption</arm_group_label>
    <description>consumption of 0.4 to 4.6 cups of tea (200 ml) per day (n=463)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High tea consumption</arm_group_label>
    <description>consumption of 4.6 to 11.9 cups of tea (200 ml) per day (n=213)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cognitive performance and cognitive decline</intervention_name>
    <description>Assess the global and domain specific (memory, speed and attention) cognitive function at baseline and over 5 years in the high vs. low/moderate tea consumption groups</description>
    <arm_group_label>High tea consumption</arm_group_label>
    <arm_group_label>low to moderate tea consumption</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Community-dwelling and institutionalized men and women recruited through general medical&#xD;
        practices in North East England, UK (n=676) and born in 1921 (85 years old at baseline).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Born in 1921&#xD;
&#xD;
          -  Permanently registered with a participating general practice in Newcastle upon Tyne or&#xD;
             North Tyneside primary care trusts in the UK&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  End-stage illness&#xD;
&#xD;
          -  Individuals who might pose a safety risk to a nurse visiting alone, with dementia&#xD;
&#xD;
          -  Clinical diagnosis of dementia at baseline&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>85 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tom Kirkwood</last_name>
    <role>Principal Investigator</role>
    <affiliation>Newcastle University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Newcastle University</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <zip>NE17RU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 8, 2017</last_update_submitted>
  <last_update_submitted_qc>September 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>tea</keyword>
  <keyword>cognition</keyword>
  <keyword>very old</keyword>
  <keyword>Newcastle 85+</keyword>
  <keyword>epidemiology</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_access_criteria>Data request</ipd_access_criteria>
    <ipd_url>http://research.ncl.ac.uk/85plus/datarequests/</ipd_url>
  </patient_data>
  <!-- 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/NCT03278743
org study id: UNewcastle
nct id: NCT03278743
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Studies have found a beneficial effect of tea consumption on the reduction of risk of
      cognitive impairment and dementia in older aged populations. However, there is a paucity of
      data on these associations in the very old defined as individuals aged 85 years and over.
      Therefore, we hypothesized that higher tea consumption was associated with better global and
      domain-specific cognitive function. We investigated the relationship between tea consumption
      in the very old and measures of global cognitive function, memory, attention and psychomotor
      speed.

      The Newcastle 85+ Study was a longitudinal (5-years), population-based cohort study of
      individuals aged 85+ years in North East England, United Kingdom. The final sample included
      676 community-dwelling and institutionalized men and women recruited through general medical
      practices.

      Baseline tea consumption was assessed through a 2x24-hr multiple pass recall and longitudinal
      measures of global and domain specific (memory, speed and attention) cognitive function
      through the standardized mini-mental state examination and the cognitive drug research
      system. Linear mixed models, controlling for demographic (e.g. age, sex and education) and
      health variables were used to determine whether tea consumption was protective against
      cognitive decline.
observational model: Cohort
time perspective: Prospective
measure: Standardized mini-mental state examination
time frame: Baseline
description: Measure of global cognition (Score 0-30)
measure: Rate of decline of the standardized mini-mental state examination
time frame: Baseline to 5 years follow-up
description: Measure of global cognition (Score 0-30)
measure: Simple reaction time
time frame: Baseline
description: Simple reaction time assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box. The participant is instructed to press "YES" as quickly as possible every time the word "YES" is presented on the screen. In total, 30 "YES" stimuli are presented with varying inter-stimulus interval. (ms)
measure: Rate of reaction speed decline
time frame: Baseline to 3 years follow-up
description: Simple reaction time assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box.The participant is instructed to press "YES" as quickly as possible every time the word "YES" is presented on the screen. In total, 30 "YES" stimuli are presented with varying inter-stimulus interval. (ms)
measure: Choice reaction time
time frame: Baseline
description: Choice reaction time assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box. Either the word "YES" or "NO" is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible. There are 30 trials for each stimulus word, which is chosen randomly with equal probability, with varying inter-stimulus interval. (ms)
measure: Rate of reaction choice decline
time frame: Baseline to 3 years follow-up
description: Choice reaction time assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box.Either the word "YES" or "NO" is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible. There are 30 trials for each stimulus word, which is chosen randomly with equal probability, with varying inter-stimulus interval. (ms)
measure: Digit vigilance task
time frame: Baseline
description: Digit vigilance task assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box. Target digit is randomly selected and constantly displayed to the right of the screen. A series of digits (0-9) are presented in the centre of the screen at the rate of 150 per minute. The participant is required to press the "YES" button as quickly as possible every time the digit in the series matches the target digit. There are 300 digits in the series and the task lasts for 2 minutes. (ms)
measure: Rate of digit vigilance task decline
time frame: Baseline to 3 years follow-up
description: Digit vigilance task assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box. Target digit is randomly selected and constantly displayed to the right of the screen. A series of digits (0-9) are presented in the centre of the screen at the rate of 150 per minute. The participant is required to press the "YES" button as quickly as possible every time the digit in the series matches the target digit. There are 300 digits in the series and the task lasts for 2 minutes. (ms)
measure: Word recognition
time frame: Baseline
description: Word recognition was assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box. A list of words is presented on screen for the subject to remember. Immediately after the presentation the subject is asked to recall as many words as possible. 20 minutes later, the same list of words is presented with added distracter words. For each word, the subject is asked to indicate whether or not it belongs o the original list by pressing 'YES' or 'NO'.
measure: Rate of word recognition decline
time frame: Baseline to 3 years follow-up
description: Word recognition was assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box.A list of words is presented on screen for the subject to remember. Immediately after the presentation the subject is asked to recall as many words as possible. 20 minutes later, the same list of words is presented with added distracter words. For each word, the subject is asked to indicate whether or not it belongs to the original list by pressing 'YES' or 'NO'.
arm group label: low to moderate tea consumption
description: consumption of 0.4 to 4.6 cups of tea (200 ml) per day (n=463)
arm group label: High tea consumption
description: consumption of 4.6 to 11.9 cups of tea (200 ml) per day (n=213)
intervention type: Other
intervention name: Cognitive performance and cognitive decline
description: Assess the global and domain specific (memory, speed and attention) cognitive function at baseline and over 5 years in the high vs. low/moderate tea consumption groups
arm group label: High tea consumption
arm group label: low to moderate tea consumption
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 85 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tom Kirkwood
role: Principal Investigator
affiliation: Newcastle University
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: Yes
ipd access criteria: Data request
ipd url: http://research.ncl.ac.uk/85plus/datarequests/