The PROMED-EX Trial
Research type
Research Study
Full title
PROMED-EX: 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 individuals at risk of undernutrition and cognitive decline.
IRAS ID
301289
Contact name
Claire McEvoy
Contact email
Sponsor organisation
Queen's University Belfast
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
1 years, 10 months, 1 days
Research summary
Undernutrition is very common in older people. About 1.3 million older adults (aged over 60 years) are undernourished, which means that they have low levels of proteins, energy, vitamins and minerals caused by reduced food intake or because the body does not process food properly. Undernutrition causes 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 UK – 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 and who have noticed a decline in their memory but have not been diagnosed with a cognitive impairment.
PROMED-EX will be conducted in partnership with a representative group of older people who will be consulted throughout the research.
Our goal is to identify potential effective solutions to undernutrition which can reduce cognitive decline and other negative health impacts on older people. The research can be used to guide public health dietary guidelines for older people to prevent undernutrition and increase healthy life years.REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
21/NW/0215
Date of REC Opinion
2 Sep 2021
REC opinion
Further Information Favourable Opinion