CognitionNCT03278743
Tea Consumption and Cognitive Performance in the Very Old
An observational study of Cognition, run by Newcastle University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 85 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition
- What is being tested?
- Cognitive performance and cognitive decline
- How many people
- 1,042 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2006to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 85 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
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).
Who may be able to join
- Born in 1921
- Permanently registered with a participating general practice in Newcastle upon Tyne or North Tyneside primary care trusts in the UK
Who cannot join
- End-stage illness
- Individuals who might pose a safety risk to a nurse visiting alone, with dementia
- Clinical diagnosis of dementia at baseline
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Cognition
- Being tested
- Cognitive performance and cognitive decline
- Keywords
- tea, cognition, very old, Newcastle 85+, epidemiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive performance and cognitive declineOther
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
| Study group | Role | What they receive |
|---|---|---|
| low to moderate tea consumption | consumption of 0.4 to 4.6 cups of tea (200 ml) per day (n=463) Receives: Other: Cognitive performance and cognitive decline | |
| High tea consumption | consumption of 4.6 to 11.9 cups of tea (200 ml) per day (n=213) Receives: Other: Cognitive performance and cognitive decline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized mini-mental state examination
Measure of global cognition (Score 0-30)
Measured: Baseline
Rate of decline of the standardized mini-mental state examination
Measure of global cognition (Score 0-30)
Measured: Baseline to 5 years follow-up
Secondary outcomes (8)
Simple reaction time
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)
Measured: Baseline
Rate of reaction speed decline
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)
Measured: Baseline to 3 years follow-up
Choice reaction time
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)
Measured: Baseline
Rate of reaction choice decline
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)
Measured: Baseline to 3 years follow-up
Digit vigilance task
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)
Measured: Baseline
Rate of digit vigilance task decline
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)
Measured: Baseline to 3 years follow-up
Word recognition
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'.
Measured: Baseline
Rate of word recognition decline
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'.
Measured: Baseline to 3 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study startJun 2006
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,042 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tom Kirkwood, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278743
- Sponsor's protocol ID
- UNewcastle
- Status last verified
- Sep 2017
- First submitted
- 14 Aug 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03278743
- Acronym / sponsor ID
- UNewcastle
- Conditions
- Cognition
- Keywords
- tea, cognition, very old, Newcastle 85+, epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,042 participants (actual)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Study start
- Jun 2006 (actual)
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low to moderate tea consumption | – | Other: Cognitive performance and cognitive declineconsumption of 0.4 to 4.6 cups of tea (200 ml) per day (n=463) |
| High tea consumption | – | Other: Cognitive performance and cognitive declineconsumption of 4.6 to 11.9 cups of tea (200 ml) per day (n=213) |
Who may qualify
- Ages
- 85 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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).
Key inclusion criteria (2 listed)
- Born in 1921
- Permanently registered with a participating general practice in Newcastle upon Tyne or North Tyneside primary care trusts in the UK
Key exclusion criteria (3 listed)
- End-stage illness
- Individuals who might pose a safety risk to a nurse visiting alone, with dementia
- Clinical diagnosis of dementia at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive performance and cognitive declineAssess 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 | Other | High tea consumption, low to moderate tea consumption |
Primary outcome
Standardized mini-mental state examination
Time frame: Baseline
Measure of global cognition (Score 0-30)
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)
8 secondary outcomes
Simple reaction time
Time frame: Baseline
Rate of reaction speed decline
Time frame: Baseline to 3 years follow-up
Choice reaction time
Time frame: Baseline
Rate of reaction choice decline
Time frame: Baseline to 3 years follow-up
Digit vigilance task
Time frame: Baseline
Rate of digit vigilance task decline
Time frame: Baseline to 3 years follow-up
Word recognition
Time frame: Baseline
Rate of word recognition decline
Time frame: Baseline to 3 years follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Kirkwood principal investigator
Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognition, run by Newcastle University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized mini-mental state examination (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2017.