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

Primary Purpose

Dementia

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Foods consistent with a MDP
Physical Activity
Control
Sponsored by
University of East Anglia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dementia focused on measuring Mediterranean Diet, Physical Activity, Dementia, Alzheimer Disease, Cognition

Eligibility Criteria

55 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of BirminghamRecruiting
  • Newcastle UniversityRecruiting
  • University of East AngliaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

MDP only

MDP plus PA

Control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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)
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

Secondary Outcome Measures

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

Full Information

First Posted
August 17, 2018
Last Updated
April 24, 2019
Sponsor
University of East Anglia
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1. Study Identification

Unique Protocol Identification Number
NCT03673722
Brief Title
Mediterranean Diet, Exercise and Dementia Risk in UK Adults
Acronym
MedEx-UK
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of East Anglia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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) 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Mediterranean Diet, Physical Activity, Dementia, Alzheimer Disease, Cognition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MDP only
Arm Type
Experimental
Arm Description
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
Arm Title
MDP plus PA
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Participants will be given generic healthy eating advice based on the NHS 'Eatwell' plate and British Heart Foundation (BHF) guidelines
Intervention Type
Other
Intervention Name(s)
Foods consistent with a MDP
Intervention Description
We aim to increase MDP by 3 points, according to a 14-point MEDAS score
Intervention Type
Other
Intervention Name(s)
Physical Activity
Intervention Description
We aim to increase PA to 150 minutes moderate activity per week.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Participants will be given generic healthy eating advice based
Primary Outcome Measure Information:
Title
Increase in MDP using the 14-point MEDAS scale
Description
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
Title
Increase in PA using activity monitors
Description
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
Secondary Outcome Measure Information:
Title
Cognition
Description
Cognitive test performance using a neuropsychological test battery which assesses various measures of global and domain specific function
Time Frame
24 weeks
Title
Neuroimaging
Description
MRI to assess regional blood flow and changes in brain structure
Time Frame
24 weeks
Title
Vascular function
Description
Assessed using Flow Mediated Dilation
Time Frame
24 weeks
Title
QRISK3 score
Description
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
Title
Blood pressure
Description
Measurements of brachial artery blood pressure and 24 hour Ambulatory Blood Pressure
Time Frame
24 weeks
Title
Blood markers
Description
Selected inflammatory cytokines, nitric oxide metabolites and brain derived neurotrophic factor (BDNF)
Time Frame
24 weeks
Title
Process evaluation
Description
Using a structured questionnaire and focus groups
Time Frame
After 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rafe Bundy, PhD
Phone
0044 1603 591236
Email
R.Bundy@uea.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Marie Minihane, PhD
Phone
0044 1603 592389
Email
A.Minihane@uea.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Marie Minihane, PhD
Organizational Affiliation
University of East Anglia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Birmingham
City
Birmingham
ZIP/Postal Code
B15 2TT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Aldred, PhD
Phone
0044 1214147284
Email
s.aldred.1@bham.ac.uk
Facility Name
Newcastle University
City
Newcastle Upon Tyne
ZIP/Postal Code
NE2 4HH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Siervo, PhD
Phone
0044 191 208 1140
Email
mario.siervo@newcastle.ac.uk
Facility Name
University of East Anglia
City
Norwich
ZIP/Postal Code
NR4 7UQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafe Bundy, PhD
Phone
00441603591236
Email
R.Bundy@uea.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33550254
Citation
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.
Results Reference
derived

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Mediterranean Diet, Exercise and Dementia Risk in UK Adults

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