PROMED-COG: PROtein enriched MEDiterranean diet to combat undernutrition and promote healthy neuroCOGnitive ageing in older adults

Lead Research Organisation: Queen's University Belfast
Department Name: Centre for Public Health

Abstract

Undernutrition caused by the deficiency of energy, protein, vitamins and/or minerals, is very common in older ages. Approximately 1.3 million people aged over 65 in the UK are considered to be undernourished; over 90% of whom live in their own home. Undernutrition has significant negative effects on health and well-being, especially for people living with cognitive impairment. It leads to weight loss and faster decline in memory and thinking (cognitive) functions, falls, infections, disability, hospital admissions and loss of independence. It can also significantly increase the risk of dementia in later life. Therefore, it is critical to find effective solutions to prevent undernutrition to help people at risk of cognitive impairment live healthier lives.

In this research, we will address identified gaps in existing knowledge by conducting a randomised controlled trial (PROMED-EX) in 105 undernourished adults with subjective memory complaint living in Northern Ireland. The aims of the PROMED-EX trial are to: (i) determine the effect of a protein enriched Mediterranean diet, with and without exercise, on cognitive function; (ii) understand how a protein enriched Mediterranean diet and exercise may act to influence nutritional status, and; (iii) evaluate the acceptability of diet and exercise to support better nutrition status and cognitive performance in older adults with subjective memory complaint.

PROMED-EX is part of a larger European project to study how undernutrition can affect dementia risk in later life. The project will provide new and critical insight into the role of undernutrition in brain ageing and dementia risk and how modifications of dietary and exercise behaviour can act to prevent undernutrition for healthy brain ageing in older citizens. Ultimately, the research will produce evidence-based lifestyle guidelines for prevention of undernutrition and, specifically, the promotion of healthy brain ageing in older adults.

Technical Summary

Dementia is a major public health challenge owing to its increasing prevalence and impact on disability and quality of life among older adults. Undernutrition, defined as a 'state resulting from inadequate food intake and/or nutrient deficiencies that leads to an altered body composition and weight loss', is common in cognitive impairment and has many adverse consequences. Undernourished dementia patients experience faster functional and cognitive decline, more psychiatric symptoms, and greater risk of hospitalisation and death, compared to those who are adequately nourished. Importantly, weight loss increases dementia risk by 30-40% and precedes a diagnosis of cognitive impairment or dementia by at least one decade, providing a window of opportunity to intervene with strategies to counteract undernutrition and delay, or prevent, the onset of dementia in later life. No prior studies have evaluated the effect of diet and exercise on cognitive performance.

The PROMED-EX trial is a single blind randomised controlled trial in 105 undernourished adults with subjective cognitive decline to: (i) test the effects of a protein optimised Mediterranean diet, with and without exercise, on nutritional status and cognitive performance; (ii) generate data on the mechanistic pathways by which the diet and exercise intervention may act to influence nutritional status and cognition, and (iii) understand the acceptability of diet and exercise to support better nutrition status and cognitive performance. PROMED-EX is part of a European Consortium project (PROMED-COG) to better understand the role of undernutrition in dementia risk and and how modifications of diet and exercise behaviour can act to reduce the burden of undernutrition and neurodegeneration. The resulting scientific knowledge will be translated into public and practice recommendations to prevent undernutrition for healthy neurocognitive ageing in older European citizens.

Publications

10 25 50
 
Description BB/W510683/1 - 21ROMITIGATIONFUND
Amount £24,700 (GBP)
Funding ID BBSRC - BB/W510683/1 - 21ROMITIGATIONFUND - R1509CPH 
Organisation Biotechnology and Biological Sciences Research Council (BBSRC) 
Sector Public
Country United Kingdom
Start 10/2021 
End 03/2022
 
Description BB/W510683/1 - 21ROMITIGATIONFUND
Amount £3,801 (GBP)
Organisation Biotechnology and Biological Sciences Research Council (BBSRC) 
Sector Public
Country United Kingdom
Start 12/2022 
End 03/2023
 
Description Department for the Economy
Amount £60,300 (GBP)
Organisation Queen's University Belfast 
Sector Academic/University
Country United Kingdom
Start 10/2021 
End 09/2024
 
Description PPI Seed Fund
Amount £1,500 (GBP)
Organisation Queen's University Belfast 
Sector Academic/University
Country United Kingdom
Start 06/2021 
End 06/2024
 
Title Exploring the relationship between Nutrition, gUT microbiota, and BRain AgINg in community-dwelling seniors: the Italian NutBrain population-based cohort study protocol 
Description Abstract Background Epidemiological evidence suggests that healthy diet is associated with a slowdown of cognitive decline leading to dementia, but the underlying mechanisms are still partially unexplored. Diet is the main determinant of gut microbiota composition, which in turn impacts on brain structures and functions, however to date no studies on this topic are available. The goal of the present paper is to describe the design and methodology of the NutBrain Study aimed at investigating the association of dietary habits with cognitive function and their role in modulating the gut microbiota composition, and brain measures as well. Methods/design This is a population-based cohort study of community-dwelling adults aged 65 years or more living in Northern Milan, Italy. At the point of presentation people are screened for cognitive functions. Socio-demographic characteristics along with lifestyles and dietary habits, medical history, drugs, functional status, and anthropometric measurements are also recorded. Individuals suspected to have cognitive impairment at the screening phase undergo a clinical evaluation including a neurological examination and a Magnetic Resonance Imaging (MRI) scanning (both structural and functional). Stool and blood samples for the gut microbiota analysis and for the evaluation of putative biological markers are also collected. For each subject with a confirmed diagnosis of Mild Cognitive Impairment (MCI), two cognitively intact controls of the same sex and age are visited. We intend to enrol at least 683 individuals for the screening phase and 240 persons for the clinical assessment. Discussion The NutBrain is an innovative study that incorporates modern and advanced technologies (i.e. microbiome and neuroimaging) into traditional epidemiologic design. The study represents a unique opportunity to address key questions about the role of modifiable risk factors on cognitive impairment, with a particular focus on dietary habits and their association with gut microbiota and markers of the brain-aging process. These findings will help to encourage and plan lifestyle interventions, for both prevention and treatment, aiming at promoting healthy cognitive ageing. Trial registration Trial registration number NCT04461951 , date of registration July 7, 2020 (retrospectively registered, ClinicalTrials.gov ). 
Type Of Material Database/Collection of data 
Year Produced 2020 
Provided To Others? Yes  
Impact Data and biobanked samples being analysed as part of the PROMED-COG project 
URL https://springernature.figshare.com/collections/Exploring_the_relationship_between_Nutrition_gUT_mic...
 
Description NuBrain: UK Consortium for Optimal Nutrition for Healthy Brain Ageing 
Organisation Newcastle University
Country United Kingdom 
Sector Academic/University 
PI Contribution Claire McEvoy invited to participate in a NuBrain UK Biobank study investigating Mediterranean diet, genetic risk and dementia
Collaborator Contribution Intellectual input and membership of the PROMED-EX Trial Steering Committee
Impact one publication in BMC Medicine [in press therefore no DOI available]
Start Year 2022
 
Title PROMED diet resource 
Description Protein enriched Mediterranean Diet written education resource, mealplan and recipe booklet to support the nutritional needs of older community dwelling adults at nutritional risk. 
Type Preventative Intervention - Nutrition and Chemoprevention
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2021
Development Status Under active development/distribution
Impact This resource is being used to support diet behaviour change in PROMED-EX and will be evaluated 
 
Description Age Friendly Belfast annual event 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Research Team hosted a stand with flyers for PROMED-EX and offered Body M.O.T [blood pressure, weight, grip strength]
Year(s) Of Engagement Activity 2022
 
Description AgeNI Podcast 'Food for Brain Health' 
Form Of Engagement Activity A broadcast e.g. TV/radio/film/podcast (other than news/press)
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact Invited Podcast that was disseminated to AgeNI network in Northern Ireland.
Year(s) Of Engagement Activity 2021
 
Description Balmoral Show event 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact Research team hosted a stand at the event with flyers on PROMED-EX and offered Body MOT [weight, blood pressure, grip strength]
Year(s) Of Engagement Activity 2022
 
Description Building Research Partnerships - PPI event 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Patients, carers and/or patient groups
Results and Impact This was a bespoke half day training session delivered by QUB researchers working and QUB public engagement team to address the identified needs of the PPI representatives in the PROMED-EX trial.
Year(s) Of Engagement Activity 2023
 
Description Collaboration with West Belfast Food Bank (FoodStock) 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact The research team approached local representative and founder of FoodStock, Paul Doherty, in order to establish a relationship and garner support for PROMED-EX in the local community. FoodStock agreed to disseminate study recruitment materials in food parcels to approximately 400 houses, as well as sharing posters on social media channels (a reach of approximately 4000 people online).
Year(s) Of Engagement Activity 2022
URL https://www.facebook.com/FoodstockCharity/photos/pcb.1222622694929442/1222622594929452/
 
Description E- Newsletter for PROMED-COG project 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Newsletter produced and circulated via social media channels and project network
Year(s) Of Engagement Activity 2022
URL https://promed-cog.com/NewsandEvents/
 
Description Healthy Brains for Healthy Populations Blog 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact This was an invited blog following the interest generated by a webinar on brain health and covering some of the key points and questions from the audience.
Year(s) Of Engagement Activity 2021
URL https://publichealth.ie/healthy-brains-for-a-healthy-population-the-road-to-a-brain-healthy-lifestyl...
 
Description Healthy Brains for Healthy Populations Webinar 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Invited by the Institute of Public Health Ireland to deliver live Webinar followed by Q&A [total time=60mins] to a broad audience. The goal was to translate current scientific knowledge into practice and identify policy areas for brain health.
Year(s) Of Engagement Activity 2021
URL https://www.youtube.com/watch?v=FlFJCzTa_Oc
 
Description Informative video for study promotion 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact The research team agreed it was important to create a range of different promotional tools in order to garner interest in the study among online communities. This short video was recorded in order to deliver a large volume of information about the study aims, design and eligibility criteria to potential study recruits, in an appealling format with minimal text. The video was posted to the PROMED-EX facebook page and has been viewed by approximately 2200 people as of 08/03/22.
Year(s) Of Engagement Activity 2022
URL https://www.facebook.com/promedcog/videos/657304342072209
 
Description Invited newspaper feature: PROMED-EX study 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact Published article on the links between diet and dementia and the PROMED-EX trial along with contact details for interested volunteers
Year(s) Of Engagement Activity 2022
URL https://www.irishnews.com/lifestyle/health/2022/07/28/news/qub_dementia_and_diet_study_seeking_volun...
 
Description Mediterranean diet and the PROMED-EX trial talk 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact Online webinar talk followed by facilitated discussion
Year(s) Of Engagement Activity 2023
 
Description Men's Health Day - Crumlin Road Gaol 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Talk on PROMED-EX and Body MOT
Year(s) Of Engagement Activity 2022
 
Description Next Door App- Social Media Posts 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact 6 posts in total on the Next Door City Centre App.
10 people reached out after seeing or engaging with one of the posts.
1/10 individuals were eligible to take part in the study.
Year(s) Of Engagement Activity 2021,2022
 
Description On foot recruitment- Community Notice Boards 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact On foot recruitment in Belfast targetting Social Supermarkets, Coffee shops, food banks, church groups, sports organisations and shopping centres with notice boards that could put up the study poster.
Year(s) Of Engagement Activity 2021,2022
 
Description PPI Showcase event 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Patients, carers and/or patient groups
Results and Impact PROMED-EX PPI representatives and study team were invited to give talk at the event to showcase PPI in research activities at QUB.
Year(s) Of Engagement Activity 2023
 
Description PROMED-COG Press Release September 2021 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Press Release added to the "News" section of the main Queen's University Belfast website on 30/09/2021. The press release could be viewed by a range of users of the QUB website and found via web search engines.
The press release was provided to partners and collaborators on PROMED-COG to translate and utilise within their resident countries - Ireland, Italy, Netherlands and Germany.
Year(s) Of Engagement Activity 2021
URL https://www.qub.ac.uk/Research/GRI/TheInstituteforGlobalFoodSecurity/institute-for-global-security-n...
 
Description PROMED-COG website 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Project website created
Year(s) Of Engagement Activity 2022
URL https://promed-cog.com/
 
Description PROMED-COG website created as a sub-site of the main Queen's University Belfast website 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Study participants or study members
Results and Impact PROMED-COG website created to provide information to public, stakeholders, industry and participants. Website contains information on QUB investigators, funding partners and collaborators, external stakeholders, patient and public involvement. Provides details of the funding received, news, events, how to make contact and information to potential participants including an embedded contact form for PROMED-EX, the intervention element of the project.
Year(s) Of Engagement Activity 2021
URL https://qub.ac.uk/sites/promed-cog
 
Description PROMED-EX- PPI event 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Patients, carers and/or patient groups
Results and Impact 8 PPI members of the PROMED-EX trial attended a half day meeting at the Centre for Public Health at QUB for a study update and social event.
Year(s) Of Engagement Activity 2022
 
Description Paid Facebook Advertisement- Facebook Carousel Advert- V3 20.11.2021 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Study participants or study members
Results and Impact Detailed targeting: Individuals aged 60 plus, Belfast (+17km)
Facebook carousel advertisement linked with PROMED-EX contact form ( embedded on PROMED-COG website created as a sub-site of the main Queen's University Belfast website)
Ran: 22nd February 2022 - 1st March 2022
£5 day/ 7 days
Individuals who saw the ad: 4,327
Link clicks:169
Participants interested in finding out more about the study: 9
Eligible Participants: n/a; screening calls booked
Year(s) Of Engagement Activity 2022
URL https://www.facebook.com/promedcog
 
Description Paid Facebook Advertisement- Facebook Carousel Advert- V3 20.11.2021 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Study participants or study members
Results and Impact Detailed targeting: Individuals aged 60 plus, Belfast (+20km)
Facebook carousel advertisement linked with PROMED-EX contact form ( embedded on PROMED-COG website created as a sub-site of the main Queen's University Belfast website)
Ran: 31st January 2022- 18th February 2022
£2 day/ 18 days
Individuals who saw the ad: 3,929
Link clicks:228
Participants interested in finding out more about the study: 11
Eligible Participants: 0
Year(s) Of Engagement Activity 2022
URL https://www.facebook.com/promedcog
 
Description Paid Facebook Advertisement- Study Poster V3 20.11.2021 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Study participants or study members
Results and Impact 19th January 2021- 29th January 2021
Cost £1/ day; ad ran for 10 days
Facebook statistics suggest ad reached 2,161 individuals aged 60 plus, within 17km of Belfast.
Approximately 3 people got in contact and wanted more information about the study, 1 of which was eligible to take part in the study
Year(s) Of Engagement Activity 2022
URL https://www.facebook.com/promedcog
 
Description Paid Facebook Advertisement- Study Poster v2, 03.08.21 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Study participants or study members
Results and Impact Detailed targeting: United Kingdom: Belfast (+17 km) Northern Ireland, males and females, 60+,
Ad ran from 08/12/2021- 19/12/2021
£14 spent over 11 days
-508 individuals saw the ad
-3 confirmed calls to study phone
-no eligible participants

-feedback from non eligible individuals interested in taking part in the study helped influence future study materials/ Facebook advertisement designs.
Year(s) Of Engagement Activity 2021
URL https://www.facebook.com/promedcog
 
Description Reimagine Remake Replay & NI Museums: Food and Mood 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact Virtual presentation delivered online with Q&A to a younger audience <25years discussing influence of food on brain health and mood.
Year(s) Of Engagement Activity 2021
 
Description Seminar Talk to PhD students enrolled in the Welcome Trust EDESIA programme (UEA) 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Postgraduate students
Results and Impact Claire McEvoy was invited to deliver Seminar at University East Anglia on Diet and cognitive decline as part of the training programme for PhD students enrolled in the EDESIA programme.
Year(s) Of Engagement Activity 2022
 
Description Senior Citizens Community group 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Talk on the PROMED-EX diet + Body M.O.T
Year(s) Of Engagement Activity 2022
 
Description Social media: Facebook community groups 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact One feature of the PROMED-EX social media strategy is the advertisement of the study in various appropriate Facebook community groups. Between late 2021 and early 2022, the study recruitment poster has been posted into the following groups based in Northern Ireland:

The Cavehill Community
Community First (based in Shankill area)
Carryduff Community
Ashton Community Trust
Need Not Greed NI
Secret Belfast
East Belfast Community - Social Prescribing
Lisburn Notice Board
Four Winds Community Page
Events in NI, Ireland and UK

Several other groups were unresponsive to the research team.
Year(s) Of Engagement Activity 2021,2022
 
Description Visit to Belfast Indoor Bowls Club 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact NW and RRM visited Belfast Indoor Bowls Club on 14/02/22 in order to advertise the PROMED-EX trial to potential study participants. This location was chosen as it is popular with the target age group for the study and provided an opportunity to share information about the study to a large number of people within a two hour period. Leaflets were distributed and discussion had with any interested individuals. The overall aim was to recruit study participants and generate 'word of mouth' in the community.
Year(s) Of Engagement Activity 2022
URL https://belfastindoorbowls.club/
 
Description Visit to Hannahstown parish church 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Attended a local parish centre on 11/10/2021 to provide information on the PROMED-EX study. This involved a presentation to a small group of interested individuals; study posters and information sheets were provided and questions arising from the discussion answered. This led to some individuals getting in touch for further information and screening.
Year(s) Of Engagement Activity 2021
 
Description Visit to Horn Head parish church 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Attended a local parish centre on 6/12/2021 to provide information on the PROMED-EX study. This involved a presentation to a small group of interested individuals; study posters and information sheets were provided and questions arising from the discussion answered. This led to some individuals getting in touch for further information and screening.
Year(s) Of Engagement Activity 2021
 
Description Visit to St Patrick's Church Parish Centre 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Attended a local parish centre on 30/11/2021 to provide information on the PROMED-EX study. This involved a presentation to a small group of interested individuals; study posters and information sheets were provided and questions arising from the discussion answered. This led to some individuals getting in touch for further information and screening.
Year(s) Of Engagement Activity 2021
 
Description Women's community group 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Invited talk on the PROMED-EX trial and body M.O.T.
Year(s) Of Engagement Activity 2022
 
Description Written piece in Belfast Live (online newspaper) 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact The research team contacted Belfast Live (a popular local news outlet) with the request that an online piece is written to promote the PROMED-EX trial. April Curtin, a staff journalist at Belfast Live, published an article online on 11 January 2022, titled "Over 60s in NI can get free expert nutrition and exercise support as part of dementia study at Queen's". Belfast Live were directed to the official PROMED-EX press release to guide their piece. Belfast Live reaches an estimated 3 million users each month with 11% of these being over the age of 65, making this a great opportunity for recruitment of study participants. The number of individuals who contacted the research team specifically as a result of seeing this article is unclear, as many people reported generic online sources such as 'internet' or 'online' as their source of information about PROMED-EX. However an influx of emails were received in the weeks following publication of this article, indicating that this was a successful media strategy.
Year(s) Of Engagement Activity 2022
URL https://www.belfastlive.co.uk/news/northern-ireland/over-60s-ni-can-free-22710790
 
Description Written piece on Select Science (online scientific communication) 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Select Science published this piece on 21 September 2021 in response to receipt of the official PROMED-EX press release. This site appears to have a predominantly academic readership therefore this written piece may have been more beneficial for raising awareness of PROMED-EX within the research community rather than within the general public.
Year(s) Of Engagement Activity 2021
URL https://www.selectscience.net/industry-news/queens-university-belfast-leads-consortium-to-better-und...