- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Newcastle upon Tyne, Spojené království, NE17RU
- Newcastle University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Standardized mini-mental state examination
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Simple reaction time
Časové okno: 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)
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Baseline
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Rate of reaction speed decline
Časové okno: 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)
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Baseline to 3 years follow-up
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Choice reaction time
Časové okno: Baseline
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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
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Rate of reaction choice decline
Časové okno: 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
Časové okno: Baseline
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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
Časové okno: Baseline to 3 years follow-up
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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
Časové okno: Baseline
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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 o the original list by pressing 'YES' or 'NO'.
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Baseline
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Rate of word recognition decline
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Tom Kirkwood, Newcastle University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
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