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

NCT05166564 | Completed DMC

• 2 other identifiers: B21/16BB/V019201/1
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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 undernourished adults with subjective cognitive decline.

Conditions

Cognitive Impairment; Poor Nutrition; Cognitive Decline

Keywords

Poor nutrition; Older adults; Cognitive impairment; Cognitive decline; Mediterranean Diet; Protein enriched Mediterranean Diet

Outcome Measures

Primary Outcomes (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.

  Baseline and 6 months

Secondary Outcomes (20)

• Mini Nutritional Assessment Score (midpoint change)

  Baseline and 3 months

• Nutrient intake: PROMED Mediterranean Diet Score

  Baseline, 3 months and 6 months

• Nutrient intake: (4 day food diary)

  Baseline, 3 months and 6 months

• Simplified Nutrition Appetite Questionnaire (SNAQ)

  Baseline, 3 months and 6 months

• Body Water (%)

  Baseline, 3 months and 6 months

Other Outcomes (2)

• Explore the acceptability and tolerance of the intervention

  6 months

• Exploratory outcome: Metabolomic profiling

  Baseline, 3 months and 6 months

Study Arms (3)

PROMED (Experimental Intervention 1)

EXPERIMENTAL

A Protein Enriched Mediterranean Diet (PROMED) intervention. Participants will receive individually tailored resources to encourage adoption of a protein-enriched Mediterranean diet pattern.

Behavioral: A Protein Enriched Mediterranean Diet (PROMED) Intervention

PROMED-EX (Experimental Intervention 2)

EXPERIMENTAL

A 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.

Behavioral: A Protein Enriched Mediterranean Diet & Exercise (PROMED-EX) Intervention

Control group

NO INTERVENTION

'Standard Care' - consisting of a general diet information sheet.

Interventions

A Protein Enriched Mediterranean Diet (PROMED) Intervention BEHAVIORAL

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.

PROMED (Experimental Intervention 1)

A Protein Enriched Mediterranean Diet & Exercise (PROMED-EX) Intervention BEHAVIORAL

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.

PROMED-EX (Experimental Intervention 2)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Queen's University, Belfast: lead
• University College Dublin: collaborator
• Wageningen University: collaborator
• Friedrich-Alexander-Universität Erlangen-Nürnberg: collaborator
• Dublin City University: collaborator

Study Sites (1)

Queen's University Belfast

Belfast, Antrim, BT12 6BJ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37880167 DERIVED

Related Links

• Link to PROMED-COG consortium and trial website

MeSH Terms

Conditions

Cognitive Dysfunction; Malnutrition

Interventions

Methods; Exercise

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Claire McEvoy, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Sealed opaque envelopes have been prepared by a member of the research team (independent of data collection). Envelops numbered with study IDs will conceal the allocated group assignment from the research team involved in screening and recruitment. Participants will be allocated a study ID number at baseline once written consent to participate has been provided. After completion of baseline measurements, a researcher (independent of outcome measurements) will open the sealed envelope corresponding to the participant's study ID to reveal the allocated group and arrange intervention delivery if required.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROMED-EX Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: December 22, 2021
• Study Start: January 18, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be made available once statistical analyses have been complete and for 10 years thereafter.
• Access Criteria: The following conditions will apply to data use: * agreement on methodology * allowance to link the dataset with other datasets * data security * agreement on publication and authorship

Locations

GB (1)