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Cognitive ImpairmentPROMED-EXNCT05166564

The PROtein Enriched MEDiterranean Diet and EXercise Trial for Older Adults At Risk of Undernutrition

A study testing A Protein Enriched Mediterranean Diet (PROMED) Intervention and A Protein Enriched Mediterranean Diet & Exercise (PROMED-EX) Intervention in people with Cognitive Impairment and Poor Nutrition, run by Queen's University, Belfast at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

PROMED-EX is a single-blind, parallel group randomised controlled trial to determine the effect of a PROtein enriched MEDiterranean diet (PROMED) in comparison to a PROtein enriched MEDiterranean diet and EXercise (PROMED-EX) intervention, or standard care on the nutritional status and cognitive performance of older… Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
What is being tested?
A Protein Enriched Mediterranean Diet (PROMED) Intervention and A Protein Enriched Mediterranean Diet & Exercise (PROMED-EX) Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteUnited Kingdom
Study dates
18 Jan 2022to 31 Jan 2025
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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Community-dwelling (non-institutionalised) participants ≥60 years older
  • A high risk of undernutrition as defined by a Mini Nutritional Assessment -Short Form (MNA-SF) score of 8 - 11
  • Positive screen for Subjective Cognitive Decline (SCD)

Who cannot join

  • Cognitive impairment determined by the Mini Mental State Assessment (MMSE) or Telephone Cognitive Screen (T-CogS)
  • Receiving oral or artificial nutritional support or medical food supplements
  • Taking high dose nutritional supplements (supplements above the Reference Nutrient Intake levels).
  • Dietary restrictions/allergies that limit ability to adhere to study requirements
  • A diagnosis of mild cognitive impairment or dementia
  • Dysphagia
Show all 11Show fewer
  • Chronic kidney disease
  • Poorly controlled diabetes (HbA1c >8% or diabetes complications)
  • Severe visual or language impairment
  • Self-reported psychiatric problems or significant medical co-morbidities that compromise the ability to take part/limit capacity to consent
  • Diagnosis of a comorbid condition that may alter performance on cognitive tests, e.g. stroke, head injury, Parkinson's disease, learning disabilities.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Queen's University Belfast

    Belfast, Antrim, BT12 6BJ

Other trials in United Kingdom

About this study

Official title: A Randomised Controlled Trial to Evaluate the Effect of a Protein Enriched Mediterranean Diet and Exercise Intervention on the Nutritional Status and Cognitive Performance of Adults At Risk of Undernutrition and Cognitive Decline

PROMED-EX is a single-blind, parallel group randomised controlled trial to determine the effect of a PROtein enriched MEDiterranean diet (PROMED) in comparison to a PROtein enriched MEDiterranean diet and EXercise (PROMED-EX) intervention, or standard care on the nutritional status and cognitive performance of older undernourished adults with subjective cognitive decline.

Read the detailed description

Undernutrition is common in older adults and can cause significant negative impacts on the health of older people, leading to weight loss and decline in cognitive function (memory and thinking abilities), loss of independence and hospitalisation. Undernutrition is associated with £23.5 billion/year in health and social care costs in the United Kingdom - over half of these costs are related to undernutrition in older adults.

Research suggests that undernutrition and weight loss occur a long time (at least 10 years) before the symptoms of cognitive decline become apparent. This means that correcting undernutrition and weight loss could help to prevent the onset of cognitive impairment.

The aim of the PROMED-EX trial is to test the effect of a 6-month protein enriched Mediterranean diet, with and without exercise, on the risk of undernutrition and cognitive decline in older adults in Northern Ireland. The PROMED-EX trial will recruit 105 older adults living in the community, at risk of poor nutrition, with a decline in memory but without a diagnosed cognitive impairment. Investigators will collect several measurements to determine the nutritional status and cognitive functioning of study participants and will repeat measurements during the study (at the start of the study, at 3 months (study midpoint) and at 6 months (study endpoint).

The goal is to identify potential effective solutions to undernutrition which can reduce cognitive decline and other negative health impacts on older adults. The research can be used to guide public health dietary guidelines for older people to prevent undernutrition and increase healthy life years.

Being tested
A Protein Enriched Mediterranean Diet (PROMED) Intervention, A Protein Enriched Mediterranean Diet & Exercise (PROMED-EX) Intervention
Keywords
Poor nutrition, Older adults, Cognitive impairment, Cognitive decline, Mediterranean Diet, Protein enriched Mediterranean Diet
Medical subject headings
Cognitive Dysfunction, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A Protein Enriched Mediterranean Diet (PROMED) InterventionBehavioural

    Researchers will provide individually tailored dietary advice and written materials to encourage 'a little and often' meal plan to support adoption of the PROMED intervention. The daily energy and protein requirements of each participant will be calculated based on National Institute of Health \& Care Excellence guidance for Nutrition Support in Adults at Risk of Malnutrition. Several resources have been developed to facilitate behaviour change: a) A PROMED Diet Information Booklet to include an overview of the PROMED Diet, tips for incorporating more PROMED foods into the diet and information on the health benefits of a PROMED diet, b) A PROMED Recipe Book offering ideas for breakfast, lunch and dinner as well as suitable snack ideas and c) key PROMED foods ordered through a local supermarket's online delivery service and delivered to participants' homes on a weekly or fortnightly basis for the 3-month active intervention phase.

  • A Protein Enriched Mediterranean Diet & Exercise (PROMED-EX) InterventionBehavioural

    Participants will receive a dietary intervention identical to PROMED participants, plus an exercise intervention. The home-based exercises are based on a modified version of the 'ExWell@home' programme developed by health professionals with significant expertise in community-based exercise rehabilitation for chronic disease. Cardiorespiratory fitness will be determined using a 3-minute step test and pulse rate. Participants will receive access to pre-recorded exercise classes and a written resource designed for older adults (ExWell@home) and adapted for the current study. Participants will be encouraged to complete two sessions per week (30-60 minutes per session). To cater for differing abilities, four levels of classes will be available for participants: Chair based, basic, standard and advanced.

Study groups in NCT05166564
Study groupRoleWhat they receive
PROMED (Experimental Intervention 1)ExperimentalA Protein Enriched Mediterranean Diet (PROMED) intervention. Participants will receive individually tailored resources to encourage adoption of a protein-enriched Mediterranean diet pattern.
Receives: Behavioral: A Protein Enriched Mediterranean Diet (PROMED) Intervention
PROMED-EX (Experimental Intervention 2)ExperimentalA Protein Enriched Mediterranean Diet \& Exercise (PROMED-EX) Intervention. Participants will receive the same PROMED diet resources (Experimental Intervention 1) and an individually tailored exercise intervention.
Receives: Behavioral: A Protein Enriched Mediterranean Diet & Exercise (PROMED-EX) Intervention
Control groupNo intervention'Standard Care' - consisting of a general diet information sheet.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mini Nutritional Assessment Score- Long Form

    The Primary outcome is change at 6 months (study endpoint) in Mini Nutritional Assessment (MNA) score between the two intervention groups and the control group. The MNA is a well validated tool with good sensitivity and specificity for predicting nutritional risk in older community dwelling adults. Scores range from 0-30 with a lower score reflecting poorer nutritional status.

    Measured: Baseline and 6 months

Secondary outcomes (20)

  1. Mini Nutritional Assessment Score (midpoint change)

    Change at 3 months from baseline in Mini Nutritional Assessment (MNA) score between the two intervention groups and the control group. The MNA is a well validated tool with good sensitivity and specificity for predicting nutritional risk in older community dwelling adults. Scores range from 0-30 with a lower score reflecting poorer nutritional status.

    Measured: Baseline and 3 months

  2. Nutrient intake: PROMED Mediterranean Diet Score

    Change at 3 and 6 months in Mediterranean Diet Score (MDS)(score range 0-14) between the two intervention groups and control. Higher scores reflect greater adherence to a Mediterranean diet.

    Measured: Baseline, 3 months and 6 months

  3. Nutrient intake: (4 day food diary)

    Change at 3 and 6 months in nutrient intakes (including protein intake) between the two intervention groups and control.

    Measured: Baseline, 3 months and 6 months

  4. Simplified Nutrition Appetite Questionnaire (SNAQ)

    Change in appetite at 3 and 6 months (from baseline). This is a brief 4-item questionnaire (score range 0-4) with lower scores suggesting deterioration of appetite.

    Measured: Baseline, 3 months and 6 months

  5. Body Water (%)

    Change in Body water (%) at 3 and 6 months (from baseline) using Bioelectrical Impedance Analysis (BodyStat 1500)

    Measured: Baseline, 3 months and 6 months

  6. Total Body Fat (%)

    Change in Total Body Fat (%) at 3 and 6 months (from baseline) using Bioelectrical Impedance Analysis (BodyStat 1500)

    Measured: Baseline, 3 months and 6 months

  7. Lean Muscle Mass (kg)

    Change in Muscle Mass (kg) at 3 and 6 months (from baseline) using Bioelectrical Impedance Analysis (BodyStat 1500)

    Measured: Baseline, 3 months and 6 months

  8. Weight (kg) and height (cm)

    Change in weight (kg) and Height (cm) at 3 and 6 months (from baseline). Both measurements will be used to calculate change in Body Mass Index (BMI) (Kg/m^2) across groups at 3 and 6 months.

    Measured: Baseline, 3 months and 6 months

  9. Waist circumference (cm)

    Change in waist circumference at 3 and 6 months (from baseline)

    Measured: Baseline, 3 months and 6 months

  10. Physical Activity determined by completion of a Recent Physical Activity Questionnaire

    Change at 3 and 6 months (from Baseline) in physical activity levels between the two intervention groups and control. This questionnaire inquires about physical activity across four domains (leisure time, occupation, commuting, and domestic life) during the past 4 weeks. Metabolic Equivalent of Task scores can be calculated and an estimation of total energy expenditure across the four domains.

    Measured: Baseline, 3 months and 6 months

  11. Capturing Changes in Cognition (Catch-Cog)

    Change at 3 and 6 months (from baseline) in cognition using the Capturing Changes in Cognition- Catch-Cog score. This composite includes an Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) word recognition (Sub score 0-12), ADAS-Cog orientation (Sub score 0-8), Controlled Oral Word Association Test (COWAT) (max number of words in 1 minute), Category Fluency Test (max number of words in 1 minute), a Digital Symbol Substitution test (correct number of symbols matched in 90 seconds), and an ADAS-Cog Word Recall Test (sub score range: 0-10). A higher score reflects better cognitive performance.

    Measured: Baseline, 3 months and 6 months

  12. Trail Making Tests (TMT) (Part A & B)

    Change in completion time of the TMT at 3 and 6 months (from baseline). Higher time reflects greater impairment.

    Measured: Baseline, 3 months and 6 months

  13. Delayed recall test (0-10)

    Change at 3 and 6 months (from baseline) in a delayed recall test of recalled learned words after a 5-minute delay (score range 0-10)

    Measured: Baseline, 3 months and 6 months

  14. Functional performance measured using the Short Physical Performance Battery (SPPB) test.

    Change at 3 and 6 months in functional performance from baseline (using the SBBP): The SPPB will test participant's Gait (time to walk 8 feet), Balance (ability to complete a side-by-side, a semi-tandem and a tandem stand) and Strength (time to complete 5 chair stands). Category scores range from 0-4 and total score (0-12) with a higher score representing better physical functioning.

    Measured: Baseline, 3 months and 6 months

  15. Grip Strength measured by isometric grip force (0-100kg)

    Change in isometric grip force (0-100kg) at 3 and 6 months (from baseline) using a Dynamometer

    Measured: Baseline, 3 months and 6 months

  16. Health-related quality of life (Short Form (SF)-36)

    Change in health related quality of life measures at 3 and 6 months between the two intervention groups and control. The SF-36 is a 36-item questionnaire (covering 8 domains of health including physical functioning; role limitations due to physical health; role limitation due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health.Scores range from 0-100 with higher score indicating a better quality of life.

    Measured: Baseline, 3 months and 6 months

  17. Geriatric Depression Scale

    Change in Depression scale at 3 and 6 months (from baseline) Scores range from 0-15. A score ≥5 indicates probable depression

    Measured: Baseline, 3 months and 6 months

  18. Systolic Blood Pressure (mmHg)

    Change at 3 and 6 months (from baseline) using a Omron automated blood pressure monitor

    Measured: Baseline, 3 months and 6 months

  19. Diastolic Blood Pressure (mmHg)

    Change at 3 and 6 months (from baseline) using an Omron automated blood pressure monitor

    Measured: Baseline, 3 months and 6 months

  20. Biochemical markers: nutritional, cardiometabolic and inflammatory

    Blood sample will be collected to determine change in serum levels of Vitamin A, Vitamin E , Carotenoids (nmol/l), change in serum lipid profile (Total cholesterol, HDL cholesterol, LDL Cholesterol and triglycerides (mmol/l)), HbA1c (mmol/mol) , fasting plasma glucose (mmol/l) and Insulin (pmol/l), High Sensitivity C-Reactive Protein (mg/l), Interleukin-6 (pg/ml),at 3 and 6 months (from Baseline).

    Measured: Baseline, 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2021
  2. Study start18 Jan 2022
  3. Primary completion31 Jan 2024
  4. Study completion31 Jan 2025

Resources

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
This study is a single blind parallel randomised controlled trial design, recruiting n=105 eligible participants and randomising into one of three groups with n=35 participants assigned into each group. Group 1: a Protein enriched Mediterranean diet (PROMED) Intervention; Group 2: a Protein enriched Mediterranean diet and exercise (PROMED-EX) intervention; and Group 3: the control group. The active intervention arms will last for three months with an additional three months of follow-up. Data will be collected from participants at study baseline, 3months and 6 months. The study statistician - independent of study recruitment, intervention delivery and data collection - has generated the randomisation scheme using a computer generated random number sequence (Release 14 StataCorp LP, College Station) assigning participant ID numbers to either the PROMED, the PROMED-EX or the control group using block randomisation in blocks of 6.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05166564
Sponsor's protocol ID
B21/16
Other IDs
BB/V019201/1, BB/V019201/1
Acronym
PROMED-EX
Status last verified
Mar 2025
First submitted
17 Sep 2021
Last updated
27 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be deposited in free open access repositories e.g. Queen's University Belfast (QUB) Pure Research portal and Zenodo (https://zenodo.org/), with guaranteed preservation of for ten years or more in order to maximise discovery and data sharing opportunities. The study description and variable metadata catalogues will be published also. Where possible, metadata will be made available through the Joint Programme Initiative: a Healthy Diet for a Healthy Life (JPI-HDHL) Meta Database (http://www.jpihdhl.eu) to maximise the visibility to the wider research community.

Publications

  • Ward NA, Reid-McCann R, Logan D, Farsi DN, Brennan L, Cardwell C, de Groot LC, Maggi S, McCaffrey N, McGuinness B, McKinley MC, Noale M, Prinelli F, Sergi G, Stevenson EJ, Trevisan C, Volkert D, Woodside JV, McEvoy CT. Effect of a PROtein-enriched MEDiterranean diet and EXercise (PROMED-EX) on nutritional status and cognitive performance in older adults at risk of undernutrition and cognitive decline: the PROMED-EX randomized controlled trial. Am J Clin Nutr. 2026 Sep;124(3):101383. doi: 10.1016/j.ajcnut.2026.101383. Epub 2026 Aug 14.

    PubMed 42680255

  • Ward NA, Reid-McCann R, Brennan L, Cardwell CR, de Groot C, Maggi S, McCaffrey N, McGuinness B, McKinley MC, Noale M, O'Neill RF, Prinelli F, Sergi G, Trevisan C, Volkert D, Woodside JV, McEvoy CT. Effects of PROtein enriched MEDiterranean Diet and EXercise on nutritional status and cognition in adults at risk of undernutrition and cognitive decline: the PROMED-EX Randomised Controlled Trial. BMJ Open. 2023 Oct 25;13(10):e070689. doi: 10.1136/bmjopen-2022-070689.

    PubMed 37880167

Questions about this trial

What is this clinical trial studying?

A study testing A Protein Enriched Mediterranean Diet (PROMED) Intervention and A Protein Enriched Mediterranean Diet & Exercise (PROMED-EX) Intervention in people with Cognitive Impairment and Poor Nutrition, run by Queen's University, Belfast at 1 site 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 3 inclusion and 11 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 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

Mini Nutritional Assessment Score- Long Form (time frame: Baseline and 6 months). 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 NCT05166564, which also lists 2 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 27 Mar 2025.

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