Mediterranean Diet, Exercise and Dementia Risk in UK Adults

NCT03673722 | Completed

• 1 other identifier: ARUK-PRRF2017-006UK
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Dementia

Keywords

Mediterranean Diet; Physical Activity; Dementia; Alzheimer Disease; Cognition

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Cognition

  24 weeks

• Neuroimaging

  24 weeks

• Vascular function

  24 weeks

• QRISK3 score

  24 weeks

• Blood pressure

  24 weeks

Study Arms (3)

MDP only

EXPERIMENTAL

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

MDP plus PA

EXPERIMENTAL

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; Other: Physical Activity

Control

PLACEBO COMPARATOR

Participants will be given generic healthy eating advice based on the NHS 'Eatwell' plate and British Heart Foundation (BHF) guidelines

Other: Control

Interventions

Foods consistent with a MDP OTHER

We aim to increase MDP by 3 points, according to a 14-point MEDAS score

MDP only; MDP plus PA

Physical Activity OTHER

We aim to increase PA to 150 minutes moderate activity per week.

MDP plus PA

Control OTHER

Participants will be given generic healthy eating advice based

Control

Eligibility Criteria

• Age: 55 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of East Anglia: lead

Study Sites (3)

University of Birmingham

Birmingham, B15 2TT, United Kingdom

Location

Newcastle University

Newcastle upon Tyne, NE2 4HH, United Kingdom

Location

University of East Anglia

Norwich, NR4 7UQ, United Kingdom

Location

Related Publications (3)

• Jennings A, Shannon OM, Gillings R, Lee V, Elsworthy R, Bundy R, Rao G, Hanson S, Hardeman W, Paddick SM, Siervo M, Aldred S, Mathers JC, Hornberger M, Minihane AM. Effectiveness and feasibility of a theory-informed intervention to improve Mediterranean diet adherence, physical activity and cognition in older adults at risk of dementia: the MedEx-UK randomised controlled trial. BMC Med. 2024 Dec 23;22(1):600. doi: 10.1186/s12916-024-03815-z.

  PMID: 39716203 DERIVED

• Elsworthy RJ, Jong ST, Hanson S, Shannon OM, Jennings A, Gillings R, Siervo M, Hornberger M, Hardeman W, Mathers JC, Minihane AM, Aldred S. Effects of the COVID-19 associated United Kingdom lockdown on physical activity in older adults at high risk of cardiovascular disease: a mixed methods perspective from the MedEx-UK multicenter trial. Front Public Health. 2024 May 9;12:1371453. doi: 10.3389/fpubh.2024.1371453. eCollection 2024.

  PMID: 38784572 DERIVED

• 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.

  PMID: 33550254 DERIVED

MeSH Terms

Conditions

Dementia; Motor Activity; Alzheimer Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavior; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anne Marie Minihane, PhD

  University of East Anglia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: September 17, 2018
• Study Start: April 1, 2019
• Primary Completion: February 26, 2021
• Study Completion: September 7, 2023
• Last Updated: December 21, 2023

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)