MedEx-UK: Mediterranean diet, exercise and dementia risk in UK adults
Research type
Research Study
Full title
A Randomised Controlled Trial investigating the feasibility of a multi-domain intervention to increase Mediterranean Diet (MedDiet) Score and Physical Activity (PA) of older UK adults who are at above average risk of dementia
IRAS ID
242410
Contact name
Anne Marie Minihane
Contact email
Sponsor organisation
University of East Anglia
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
MedEx-UK is a RCT that will evaluate the feasibility of a multi-domain intervention to increase Mediterranean Dietary Pattern (MDP) adherence and physical activity (PA) in a group of older UK adults who are at above average risk of dementia.
In cohort studies, an MDP has been consistently associated with reduced dementia incidence. The efficacy of an MDP to prevent dementia has never been directly demonstrated by RCTs, with existing research limited to cognition as a secondary outcome in a single study. Furthermore, despite their likely additive effects, the combined impact of PA and a MDP on dementia risk is unknown.
In MedEx-UK we propose to conduct a feasibility study in three UK centres (Norwich, Birmingham, Newcastle) which collectively will recruit 108 UK older adults (55-74y) who are above average risk of dementia, but pre-clinical. Our primary outcome is to increase MDP adherence and PA over a 24 week period, to demonstrate that it is possible to achieve meaningful behavioral change in such a UK population. Our secondary outcomes will be to measure the sensitivity of various cognitive assessments and measure the variability of our primary and secondary outcome measures in this population at baseline and in response to intervention.
The overall purpose of this feasibility study is to inform the future design of a large-scale UK dementia risk reduction RCT, to observe whether a multi-domain intervention over 2 to 5 years promoting MDP adherence and increased PA can reduce cognitive decline and brain atrophy in adults at above average risk of dementia.
REC name
HSC REC A
REC reference
18/NI/0191
Date of REC Opinion
29 Nov 2018
REC opinion
Further Information Favourable Opinion