- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Newcastle upon Tyne, Соединенное Королевство, NE17RU
- Newcastle University
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
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
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Standardized mini-mental state examination
Временное ограничение: Baseline
|
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
Временное ограничение: Baseline to 5 years follow-up
|
Measure of global cognition (Score 0-30)
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Baseline to 5 years follow-up
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Simple reaction time
Временное ограничение: 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)
|
Baseline
|
|
Rate of reaction speed decline
Временное ограничение: 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
|
|
Choice reaction time
Временное ограничение: 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
Временное ограничение: 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)
|
Baseline to 3 years follow-up
|
|
Digit vigilance task
Временное ограничение: 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)
|
Baseline
|
|
Rate of digit vigilance task decline
Временное ограничение: 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)
|
Baseline to 3 years follow-up
|
|
Word recognition
Временное ограничение: 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'.
|
Baseline
|
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Rate of word recognition decline
Временное ограничение: 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'.
|
Baseline to 3 years follow-up
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Tom Kirkwood, Newcastle University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- UNewcastle
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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