- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT03278743
Tea Consumption and Cognitive Performance in the Very Old
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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Tényleges)
Kapcsolatok és helyek
Tanulmányi helyek
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Newcastle upon Tyne, Egyesült Királyság, NE17RU
- Newcastle University
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
|---|---|
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low to moderate tea consumption
consumption of 0.4 to 4.6 cups of tea (200 ml) per day (n=463)
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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
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High tea consumption
consumption of 4.6 to 11.9 cups of tea (200 ml) per day (n=213)
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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
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Standardized mini-mental state examination
Időkeret: Baseline
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Measure of global cognition (Score 0-30)
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Baseline
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Rate of decline of the standardized mini-mental state examination
Időkeret: Baseline to 5 years follow-up
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Measure of global cognition (Score 0-30)
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Baseline to 5 years follow-up
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Simple reaction time
Időkeret: Baseline
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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)
|
Baseline
|
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Rate of reaction speed decline
Időkeret: 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)
|
Baseline to 3 years follow-up
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Choice reaction time
Időkeret: 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)
|
Baseline
|
|
Rate of reaction choice decline
Időkeret: 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)
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Baseline to 3 years follow-up
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Digit vigilance task
Időkeret: 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)
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Baseline
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Rate of digit vigilance task decline
Időkeret: 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)
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Baseline to 3 years follow-up
|
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Word recognition
Időkeret: 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'.
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Baseline
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Rate of word recognition decline
Időkeret: Baseline to 3 years follow-up
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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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Baseline to 3 years follow-up
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Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Tom Kirkwood, Newcastle University
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
Egyéb vizsgálati azonosító számok
- UNewcastle
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD-megosztási hozzáférési feltételek
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