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Tea Consumption and Cognitive Performance in the Very Old

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ClinicalTrials.gov Identifier: NCT03278743
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Newcastle University

Brief Summary:

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.


Condition or disease Intervention/treatment
Cognition Other: Cognitive performance and cognitive decline

Study Type : Observational
Actual Enrollment : 1042 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : June 2006
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
low to moderate tea consumption
consumption of 0.4 to 4.6 cups of tea (200 ml) per day (n=463)
Other: Cognitive performance and cognitive decline
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

High tea consumption
consumption of 4.6 to 11.9 cups of tea (200 ml) per day (n=213)
Other: Cognitive performance and cognitive decline
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




Primary Outcome Measures :
  1. Standardized mini-mental state examination [ Time Frame: Baseline ]
    Measure of global cognition (Score 0-30)

  2. Rate of decline of the standardized mini-mental state examination [ Time Frame: Baseline to 5 years follow-up ]
    Measure of global cognition (Score 0-30)


Secondary Outcome Measures :
  1. Simple reaction time [ Time Frame: Baseline ]
    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)

  2. Rate of reaction speed decline [ Time Frame: Baseline to 3 years follow-up ]
    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)

  3. Choice reaction time [ Time Frame: Baseline ]
    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)

  4. Rate of reaction choice decline [ Time Frame: Baseline to 3 years follow-up ]
    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)

  5. Digit vigilance task [ Time Frame: Baseline ]
    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)

  6. Rate of digit vigilance task decline [ Time Frame: Baseline to 3 years follow-up ]
    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)

  7. Word recognition [ Time Frame: Baseline ]
    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'.

  8. Rate of word recognition decline [ Time Frame: Baseline to 3 years follow-up ]
    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'.



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Ages Eligible for Study:   85 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community-dwelling and institutionalized men and women recruited through general medical practices in North East England, UK (n=676) and born in 1921 (85 years old at baseline).
Criteria

Inclusion Criteria:

  • Born in 1921
  • Permanently registered with a participating general practice in Newcastle upon Tyne or North Tyneside primary care trusts in the UK

Exclusion Criteria:

  • End-stage illness
  • Individuals who might pose a safety risk to a nurse visiting alone, with dementia
  • Clinical diagnosis of dementia at baseline

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278743


Locations
United Kingdom
Newcastle University
Newcastle upon Tyne, United Kingdom, NE17RU
Sponsors and Collaborators
Newcastle University
Investigators
Principal Investigator: Tom Kirkwood Newcastle University

Responsible Party: Newcastle University
ClinicalTrials.gov Identifier: NCT03278743     History of Changes
Other Study ID Numbers: UNewcastle
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Access Criteria: Data request
URL: http://research.ncl.ac.uk/85plus/datarequests/

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Newcastle University:
tea
cognition
very old
Newcastle 85+
epidemiology