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

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

Interventions

BEHAVIORAL

A Protein Enriched Mediterranean Diet (PROMED) Intervention

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.

BEHAVIORAL

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

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.

Sponsors & Collaborators

• University College Dublin

  collaborator OTHER

• Wageningen University

  collaborator OTHER

• Friedrich-Alexander-Universität Erlangen-Nürnberg

  collaborator OTHER

• Dublin City University

  collaborator OTHER

• Queen's University, Belfast

  lead OTHER

Principal Investigators

• Claire McEvoy, PhD · Queen's University, Belfast

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-01-18

Primary Completion

2024-01-31

Completion

2025-01-31

Countries

• United Kingdom

Study Locations