- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
-
Newcastle upon Tyne, Royaume-Uni, NE17RU
- Newcastle University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
low to moderate tea consumption
consumption of 0.4 to 4.6 cups of tea (200 ml) per day (n=463)
|
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)
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Standardized mini-mental state examination
Délai: Baseline
|
Measure of global cognition (Score 0-30)
|
Baseline
|
Rate of decline of the standardized mini-mental state examination
Délai: Baseline to 5 years follow-up
|
Measure of global cognition (Score 0-30)
|
Baseline to 5 years follow-up
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Simple reaction time
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Rate of word recognition decline
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Tom Kirkwood, Newcastle University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- UNewcastle
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Critères d'accès au partage IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Cognitive performance and cognitive decline
-
Afyonkarahisar Health Sciences UniversityRecrutementAccident vasculaire cérébralTurquie
-
University of California, San FranciscoComplétéLa schizophrénie | PsychoseÉtats-Unis
-
Hospital de Clinicas de Porto AlegreYale UniversityInconnueTrouble déficitaire de l'attention/hyperactivité.Brésil
-
University of MalayaRésiliéDéficience cognitive | Déclin cognitif | Détérioration cognitiveMalaisie
-
Icahn School of Medicine at Mount SinaiNational Institute of Mental Health (NIMH)Complété
-
Icahn School of Medicine at Mount SinaiComplété
-
Duke UniversityComplété
-
Science and Research Centre KoperAlbert Einstein College of Medicine; University of Primorska; Vrije Universiteit...ComplétéDéficience cognitive | Vieillissement | Déclin cognitif | Coordination ou fonction motriceSlovénie
-
Xuanwu Hospital, BeijingRecrutementDéficience cognitive légèreChine
-
Chang Gung Memorial HospitalRecrutementMCI | SCD | Réalité virtuelleTaïwan