In cohort studies, a Mediterranean Dietary Pattern (MDP) has been consistently associated with reduced dementia incidence. The efficacy of a MDP to prevent dementia has never been directly demonstrated by RCTs, with existing research limited to cognition as a secondary outcome. Furthermore, despite their likely additive effects, the combined impact of Physical Activity (PA) and a MDP on dementia risk is unknown. 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 MedEx-UK the investigators 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 at above average risk of dementia, but pre-clinical. Primary outcome is to evaluate the feasibility of a multi-domain intervention to increase MDP adherence and PA over a 24 week period, and to demonstrate the possibility of achieving meaningful behavioural change in a UK population. 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. There are three intervention arms to the study, and participants will be randomised with minimisation for gender and Mediterranean Diet Adherence Screener score (MEDAS; a validated questionnaire) 1. MDP: Participants will be asked to alter their consumption of foods consistent with a Mediterranean Diet. Examples include increased intake of fruits and vegetables, nuts, olive oil as the main culinary fat, moderate wine consumption (if they already consume alcohol), preferring white meat over red, and a reduction in commercial sweet and pastries, and sugar-sweetened drinks. 2. MDP plus PA: As well as the dietary intervention as in 1., participants will be asked to increase their PA using a mixture of structured (e.g. dancing, Zumba classes, swimming etc.) and non-structured (walking up stairs, gardening etc.) activities. 3. Control: Participants will be given generic healthy eating advice based on the NHS 'Eatwell' plate and UK British Heart Foundation (BHF) guidelines. The overall purpose of this study is to inform the feasibility and design of a future 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
108
We aim to increase MDP by 3 points, according to a 14-point MEDAS score
We aim to increase PA to 150 minutes moderate activity per week.
Participants will be given generic healthy eating advice based
University of Birmingham
Birmingham, United Kingdom
Newcastle University
Newcastle upon Tyne, United Kingdom
University of East Anglia
Norwich, United Kingdom
Increase in MDP using the 14-point MEDAS scale
The extent to which the Mediterranean Dietary Pattern has improved, the target being an increase in 3 points of a 14-point scale, as assessed by Dietary Recall software (Intake 24) and a validated questionnaire (14-point MEDAS)
Time frame: 24 weeks
Increase in PA using activity monitors
The extent to which Physical Activity levels have increased, the target being 150 minutes of moderate activity per week, assessed using an activity monitor worn by participants throughout the 24 week intervention period
Time frame: 24 weeks
Cognition
Cognitive test performance using a neuropsychological test battery which assesses various measures of global and domain specific function
Time frame: 24 weeks
Neuroimaging
MRI to assess regional blood flow and changes in brain structure
Time frame: 24 weeks
Vascular function
Assessed using Flow Mediated Dilation
Time frame: 24 weeks
QRISK3 score
Using a measurement of participant cholesterol levels and other data needed to calculate QRISK3 score (which assesses CVD risk; see www.qrisk.org/three/)
Time frame: 24 weeks
Blood pressure
Measurements of brachial artery blood pressure and 24 hour Ambulatory Blood Pressure
Time frame: 24 weeks
Blood markers
Selected inflammatory cytokines, nitric oxide metabolites and brain derived neurotrophic factor (BDNF)
Time frame: 24 weeks
Process evaluation
Using a structured questionnaire and focus groups
Time frame: After 24 weeks
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