Mediterranean Diet, Exercise and Dementia Risk in UK Adults (MedEx-UK)

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

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.

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Other: Foods consistent with a MDP; Other: Physical Activity; Other: Control

Detailed Description

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
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom, B15 2TT
    • University of Birmingham
  • Newcastle Upon Tyne, United Kingdom, NE2 4HH
    • Newcastle University
  • Norwich, United Kingdom, NR4 7UQ
    • University of East Anglia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male and female, aged 55-74 years
• Understands and is willing and able to comply with all study procedures, including changes to diet and physical activity levels
• Access to, and able to use, the internet/computer/tablet device
• QRISK3 score of >=15 (assessed by GP)
• Subjective Memory Complaints (SMC), based on a score of >16 on the Cognitive Change Index (CCI) (from the first 12 items)
• Stable use of any prescribed medication for at least four weeks
• Normal (or corrected to normal) vision and hearing
• Fluent in written and spoken English
• Willing and able to provide written informed consent

Exclusion Criteria:

• Diagnosis of Alzheimer's disease (AD), other form of dementia, Mild Cognitive Impairment (MCI), or significant neurological disorder
• Cognition not within normal range, based on a score of <26 on the Montreal Cognitive Assessment (MoCA); or an indication of cognitive decline, based on a score of ≥2 on Ascertain Dementia (AD-8)
• Evidence of impairment of Instrumental Activities of Daily living (IADLS)
• Moderate to severe depression, assessed by the Patient Health Questionnaire (PHQ-9), a score of >10 being exclusionary
• Moderate to severe anxiety, assessed by the Generalised Anxiety Disorder Assessment (GAD-7), a score of >10 being exclusionary
• Current psychotic illness (delusional disorder/schizophrenia)
• History of serious mental illness know to affect cognition (schizophrenia, schizoaffective disorder, bipolar disorder)
• Subjects with other clinically diagnosed psychiatric disorders likely to affect the cognitive measures (as judged by a clinical advisor)
• HIV positive
• Past history or previous MRI evidence of brain damage, significant head trauma (including loss of consciousness as a result), brain surgery, stroke, or serious neurological disorders
• History of alcohol or drug dependency in the last 2 years
• Subjects with existing diagnosed gastrointestinal disorders likely to impact study results (as judged by a clinical advisor)
• History of any major cardiovascular event, such as a myocardial infarction, stroke or TIA
• Diagnosed COPD
• Cancer, or cancer/treatment within the last 12 months
• Diagnosis of type 1 or type 2 diabetes < 3 months ago
• Clinical diagnosis of liver or kidney disease
• Diagnosed Epilepsy
• Subjects with any other existing medical conditions likely to affect the study measures
• BMI >40kg/m2
• A habitual Mediterranean Diet Score (MDS) ≥9
• Habitual physical activity of >60 minutes moderate activity per week, assessed using the International Physical Activity Questionnaire (IPAQ), short form
• Currently actively engaged in a weight loss, other dietary, or physical activity intervention
• Prescribed medications likely to influence the study measures (as judged by a clinical advisor)
• Currently a participant or have participated in any other study involving an investigational product in the last 4 weeks
• Metal implants, e.g. pacemaker that precludes MRI.
• Claustrophobic which precludes MRI scanning.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MDP only; Participants will be asked to increase their consumption of foods that are consistent with a Mediterranean Dietary Pattern through interaction with the online LEAP2 platform	Other: Foods consistent with a MDP; We aim to increase MDP by 3 points, according to a 14-point MEDAS score
Experimental: MDP plus PA; Participants will be asked to increase their consumption of foods that are consistent with a Mediterranean Dietary Pattern AND to increase Physical Activity using a mixture of structured and non-structured activities through interaction with the online LEAP2 platform	Other: Foods consistent with a MDP; We aim to increase MDP by 3 points, according to a 14-point MEDAS score; Other: Physical Activity; We aim to increase PA to 150 minutes moderate activity per week.
Placebo Comparator: Control; Participants will be given generic healthy eating advice based on the NHS 'Eatwell' plate and British Heart Foundation (BHF) guidelines	Other: Control; Participants will be given generic healthy eating advice based

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognition	Cognitive test performance using a neuropsychological test battery which assesses various measures of global and domain specific function	24 weeks
Neuroimaging	MRI to assess regional blood flow and changes in brain structure	24 weeks
Vascular function	Assessed using Flow Mediated Dilation	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/)	24 weeks
Blood pressure	Measurements of brachial artery blood pressure and 24 hour Ambulatory Blood Pressure	24 weeks
Blood markers	Selected inflammatory cytokines, nitric oxide metabolites and brain derived neurotrophic factor (BDNF)	24 weeks
Process evaluation	Using a structured questionnaire and focus groups	After 24 weeks

Collaborators and Investigators

• Sponsor: University of East Anglia
• Investigators: Principal Investigator: Anne Marie Minihane, PhD, University of East Anglia

Publications and helpful links

General Publications

• Shannon OM, Lee V, Bundy R, Gillings R, Jennings A, Stephan B, Hornberger M, Balanos G, Paddick SM, Hanson S, Hardeman W, Holmes R, Garner N, Aldred S, Siervo M, Mathers JC, Minihane AM. Feasibility and acceptability of a multi-domain intervention to increase Mediterranean diet adherence and physical activity in older UK adults at risk of dementia: protocol for the MedEx-UK randomised controlled trial. BMJ Open. 2021 Feb 5;11(2):e042823. doi: 10.1136/bmjopen-2020-042823.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): February 26, 2021
• Study Completion (Actual): September 7, 2023

Study Registration Dates

• First Submitted: August 17, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Physical Activity; Dementia; Alzheimer Disease; Cognition; Mediterranean Diet
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: ARUK-PRRF2017-006UK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No