NCT05166564

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Queen's University, Belfast · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Cognitive Impairment
• Poor Nutrition
• Cognitive Decline

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-18
• Primary completion: 2024-01-31
• Completion: 2025-01-31
• First posted: 2021-12-22
• Last updated: 2025-03-27

Locations

1 site across 1 country: United Kingdom