NCT03278743

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,042

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
Last Updated

September 12, 2017

Status Verified

September 1, 2017

Enrollment Period

6.8 years

First QC Date

August 14, 2017

Last Update Submit

September 8, 2017

Conditions

Keywords

teacognitionvery oldNewcastle 85+epidemiology

Outcome Measures

Primary Outcomes (2)

  • Standardized mini-mental state examination

    Measure of global cognition (Score 0-30)

    Baseline

  • Rate of decline of the standardized mini-mental state examination

    Measure of global cognition (Score 0-30)

    Baseline to 5 years follow-up

Secondary Outcomes (8)

  • Simple reaction time

    Baseline

  • Rate of reaction speed decline

    Baseline to 3 years follow-up

  • Choice reaction time

    Baseline

  • Rate of reaction choice decline

    Baseline to 3 years follow-up

  • Digit vigilance task

    Baseline

  • +3 more secondary outcomes

Study Arms (2)

low to moderate tea consumption

consumption of 0.4 to 4.6 cups of tea (200 ml) per day (n=463)

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)

Other: Cognitive performance and cognitive decline

Interventions

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 consumptionlow to moderate tea consumption

Eligibility Criteria

Age85 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • Born in 1921
  • Permanently registered with a participating general practice in Newcastle upon Tyne or North Tyneside primary care trusts in the UK

You may not qualify if:

  • End-stage illness
  • Individuals who might pose a safety risk to a nurse visiting alone, with dementia
  • Clinical diagnosis of dementia at baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Newcastle University

Newcastle upon Tyne, NE17RU, United Kingdom

Location

Study Officials

  • Tom Kirkwood

    Newcastle University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2017

First Posted

September 12, 2017

Study Start

June 1, 2006

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

September 12, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will share
Access Criteria
Data request
More information

Locations