The PROtein Enriched MEDiterranean Diet and EXercise Trial for Older Adults At Risk of Undernutrition (PROMED-EX)

Queen's University Belfast

Status: Completed

Conditions: Cognitive Impairment; Cognitive Decline; Poor Nutrition

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05166564

BB/V019201/1 (Other Grant/Funding Number)

B21/16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 3 patient groups

PROMED (Experimental Intervention 1)

Experimental group

Description:

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

Treatment:

Behavioral: A Protein Enriched Mediterranean Diet (PROMED) Intervention

PROMED-EX (Experimental Intervention 2)

Experimental group

Description:

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.

Treatment:

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

Control group

No Intervention group

Description:

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