Clinical trial NCT05166564: The PROtein Enriched MEDiterranean Diet and EXercise Trial for Older Adults At Risk of Undernutrition
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Poor Nutrition
Cognitive Decline
Keywords: Poor nutrition
Older adults
Cognitive impairment
Cognitive decline
Mediterranean Diet
Protein enriched Mediterranean Diet
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: University College Dublin
name: Wageningen University
name: Friedrich-Alexander-Universität Erlangen-Nürnberg
name: Dublin City University
First posted: 2021-12-22
Enrollment: 105
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mini Nutritional Assessment Score- Long Form
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Mini Nutritional Assessment Score (midpoint change)
timeFrame: Baseline and 3 months
measure: Nutrient intake: PROMED Mediterranean Diet Score
timeFrame: Baseline, 3 months and 6 months
measure: Nutrient intake: (4 day food diary)
timeFrame: Baseline, 3 months and 6 months
measure: Simplified Nutrition Appetite Questionnaire (SNAQ)
timeFrame: Baseline, 3 months and 6 months
measure: Body Water (%)
timeFrame: Baseline, 3 months and 6 months
measure: Total Body Fat (%)
timeFrame: Baseline, 3 months and 6 months
measure: Lean Muscle Mass (kg)
timeFrame: Baseline, 3 months and 6 months
measure: Weight (kg) and height (cm)
timeFrame: Baseline, 3 months and 6 months
measure: Waist circumference (cm)
timeFrame: Baseline, 3 months and 6 months
measure: Physical Activity determined by completion of a Recent Physical Activity Questionnaire
timeFrame: Baseline, 3 months and 6 months
measure: Capturing Changes in Cognition (Catch-Cog)
timeFrame: Baseline, 3 months and 6 months
measure: Trail Making Tests (TMT) (Part A & B)
timeFrame: Baseline, 3 months and 6 months
measure: Delayed recall test (0-10)
timeFrame: Baseline, 3 months and 6 months
measure: Functional performance measured using the Short Physical Performance Battery (SPPB) test.
timeFrame: Baseline, 3 months and 6 months
measure: Grip Strength measured by isometric grip force (0-100kg)
timeFrame: Baseline, 3 months and 6 months
measure: Health-related quality of life (Short Form (SF)-36)
timeFrame: Baseline, 3 months and 6 months
measure: Geriatric Depression Scale
timeFrame: Baseline, 3 months and 6 months
measure: Systolic Blood Pressure (mmHg)
timeFrame: Baseline, 3 months and 6 months
measure: Diastolic Blood Pressure (mmHg)
timeFrame: Baseline, 3 months and 6 months
measure: Biochemical markers: nutritional, cardiometabolic and inflammatory
timeFrame: Baseline, 3 months and 6 months
Other outcomes:
measure: Explore the acceptability and tolerance of the intervention
timeFrame: 6 months
measure: Exploratory outcome: Metabolomic profiling
timeFrame: Baseline, 3 months and 6 months
Locations:
city: Belfast
country: United Kingdom
facility: Queen's University Belfast
state: Antrim
Study officials:
affiliation: Queen's University, Belfast
name: Claire McEvoy, PhD
role: PRINCIPAL_INVESTIGATOR
References: