DementiaMedEx-UKNCT03673722
Mediterranean Diet, Exercise and Dementia Risk in UK Adults
A study testing Foods consistent with a MDP and Physical Activity in people with Dementia, run by University of East Anglia at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Foods consistent with a MDP and Physical Activity
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 1 Apr 2019to 7 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Normal (or corrected to normal) vision and hearing
- Fluent in written and spoken English
- Willing and able to provide written informed consent
Who cannot join
- 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)
Show all 27Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
University of Birmingham
Birmingham, B15 2TT
Newcastle University
Newcastle upon Tyne, NE2 4HH
University of East Anglia
Norwich, NR4 7UQ
About this study
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
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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Foods consistent with a MDP, Physical Activity, Control
- Keywords
- Mediterranean Diet, Physical Activity, Dementia, Alzheimer Disease, Cognition
- Medical subject headings
- Dementia, Motor Activity, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foods consistent with a MDPOther
We aim to increase MDP by 3 points, according to a 14-point MEDAS score
Physical ActivityOther
We aim to increase PA to 150 minutes moderate activity per week.
ControlOther
Participants will be given generic healthy eating advice based
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 24 weeks
Secondary outcomes (7)
Cognition
Cognitive test performance using a neuropsychological test battery which assesses various measures of global and domain specific function
Measured: 24 weeks
Neuroimaging
MRI to assess regional blood flow and changes in brain structure
Measured: 24 weeks
Vascular function
Assessed using Flow Mediated Dilation
Measured: 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/)
Measured: 24 weeks
Blood pressure
Measurements of brachial artery blood pressure and 24 hour Ambulatory Blood Pressure
Measured: 24 weeks
Blood markers
Selected inflammatory cytokines, nitric oxide metabolites and brain derived neurotrophic factor (BDNF)
Measured: 24 weeks
Process evaluation
Using a structured questionnaire and focus groups
Measured: After 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start1 Apr 2019
- Primary completion26 Feb 2021
- Study completion7 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Marie Minihane, PhD, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673722
- Sponsor's protocol ID
- ARUK-PRRF2017-006UK
- Acronym
- MedEx-UK
- Status last verified
- Aug 2018
- First submitted
- 17 Aug 2018
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39716203Elsworthy 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.
PubMed 38784572Shannon 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.
PubMed 33550254
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03673722
- Acronym / sponsor ID
- MedEx-UK / ARUK-PRRF2017-006UK
- Conditions
- Dementia
- Keywords
- Mediterranean Diet, Physical Activity, Dementia, Alzheimer Disease, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| MDP only | Experimental | Other: Foods consistent with a MDPParticipants will be asked to increase their consumption of foods that are consistent with a Mediterranean Dietary Pattern through interaction with the online LEAP2 platform |
| MDP plus PA | Experimental | Other: Foods consistent with a MDP, Other: Physical ActivityParticipants 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 |
| Control | Placebo comparator | Other: ControlParticipants will be given generic healthy eating advice based on the NHS 'Eatwell' plate and British Heart Foundation (BHF) guidelines |
Who may qualify
- Ages
- 55 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foods consistent with a MDPWe aim to increase MDP by 3 points, according to a 14-point MEDAS score | Other | MDP only, MDP plus PA |
| Physical ActivityWe aim to increase PA to 150 minutes moderate activity per week. | Other | MDP plus PA |
| ControlParticipants will be given generic healthy eating advice based | Other | Control |
Primary outcome
Increase in MDP using the 14-point MEDAS scale
Time frame: 24 weeks
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
Time frame: 24 weeks
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
7 secondary outcomes
Cognition
Time frame: 24 weeks
Neuroimaging
Time frame: 24 weeks
Vascular function
Time frame: 24 weeks
QRISK3 score
Time frame: 24 weeks
Blood pressure
Time frame: 24 weeks
Blood markers
Time frame: 24 weeks
Process evaluation
Time frame: After 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Derived from this study: PubMed 39716203Jennings 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.
- Derived from this study: PubMed 38784572Elsworthy 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.
- Derived from this study: PubMed 33550254Shannon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Marie Minihane, PhD principal investigator
University of East Anglia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foods consistent with a MDP and Physical Activity in people with Dementia, run by University of East Anglia at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in MDP using the 14-point MEDAS scale (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03673722, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.