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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-18

Study Completion Date

2025-01-31

Brief Summary

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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.

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Detailed Description

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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

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Cognitive Impairment Poor Nutrition Cognitive Decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Sealed opaque envelopes have been prepared by a member of the research team (independent of data collection). Envelops numbered with study IDs will conceal the allocated group assignment from the research team involved in screening and recruitment. Participants will be allocated a study ID number at baseline once written consent to participate has been provided. After completion of baseline measurements, a researcher (independent of outcome measurements) will open the sealed envelope corresponding to the participant's study ID to reveal the allocated group and arrange intervention delivery if required.

Study Groups

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PROMED (Experimental Intervention 1)

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

Group Type EXPERIMENTAL

A Protein Enriched Mediterranean Diet (PROMED) Intervention

Intervention Type BEHAVIORAL

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.

PROMED-EX (Experimental Intervention 2)

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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes