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

Cognitive Impairment Clinical Trial

— PROMED-EX  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05166564
• Other study ID #: B21/16
• Secondary ID: BB/V019201/1BB/V
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: August 2023
• Source: Queen's University, Belfast
• Contact: Claire McEvoy, PhD
• Phone: +44 (0)28 9097 6078
• Email: c.mcevoy[@]qub.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment
• Malnutrition
• Poor Nutrition

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Queen's University Belfast	Belfast	Antrim

Sponsors (5)

Lead Sponsor	Collaborator
Queen's University, Belfast	Dublin City University, Friedrich-Alexander-Universität Erlangen-Nürnberg, University College Dublin, Wageningen University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Explore the acceptability and tolerance of the intervention	A study evaluation questionnaire will be administered to participants at 6 months to determine acceptability, tolerance and potential adverse effects of the intervention components and the intervention materials	6 months
Other	Exploratory outcome: Metabolomic profiling	The blood samples required for Metabolomics analysis will be transferred to University College Dublin.; An exploratory outcome using both targeted and untargeted approaches. Metabolomics will be performed using NMR and LC-MS-based approaches.	Baseline, 3 months and 6 months
Primary	Mini Nutritional Assessment Score- Long Form	The Primary outcome is change at 6 months (study endpoint) in Mini Nutritional Assessment (MNA) score between the two intervention groups and the control group. The MNA is a well validated tool with good sensitivity and specificity for predicting nutritional risk in older community dwelling adults. Scores range from 0-30 with a lower score reflecting poorer nutritional status.	Baseline and 6 months
Secondary	Mini Nutritional Assessment Score (midpoint change)	Change at 3 months from baseline in Mini Nutritional Assessment (MNA) score between the two intervention groups and the control group. The MNA is a well validated tool with good sensitivity and specificity for predicting nutritional risk in older community dwelling adults. Scores range from 0-30 with a lower score reflecting poorer nutritional status.	Baseline and 3 months
Secondary	Nutrient intake: PROMED Mediterranean Diet Score	Change at 3 and 6 months in Mediterranean Diet Score (MDS)(score range 0-14) between the two intervention groups and control. Higher scores reflect greater adherence to a Mediterranean diet.	Baseline, 3 months and 6 months
Secondary	Nutrient intake: (4 day food diary)	Change at 3 and 6 months in nutrient intakes (including protein intake) between the two intervention groups and control.	Baseline, 3 months and 6 months
Secondary	Simplified Nutrition Appetite Questionnaire (SNAQ)	Change in appetite at 3 and 6 months (from baseline). This is a brief 4-item questionnaire (score range 0-4) with lower scores suggesting deterioration of appetite.	Baseline, 3 months and 6 months
Secondary	Body Water (%)	Change in Body water (%) at 3 and 6 months (from baseline) using Bioelectrical Impedance Analysis (BodyStat 1500)	Baseline, 3 months and 6 months
Secondary	Total Body Fat (%)	Change in Total Body Fat (%) at 3 and 6 months (from baseline) using Bioelectrical Impedance Analysis (BodyStat 1500)	Baseline, 3 months and 6 months
Secondary	Lean Muscle Mass (kg)	Change in Muscle Mass (kg) at 3 and 6 months (from baseline) using Bioelectrical Impedance Analysis (BodyStat 1500)	Baseline, 3 months and 6 months
Secondary	Weight (kg) and height (cm)	Change in weight (kg) and Height (cm) at 3 and 6 months (from baseline). Both measurements will be used to calculate change in Body Mass Index (BMI) (Kg/m^2) across groups at 3 and 6 months.	Baseline, 3 months and 6 months
Secondary	Waist circumference (cm)	Change in waist circumference at 3 and 6 months (from baseline)	Baseline, 3 months and 6 months
Secondary	Physical Activity determined by completion of a Recent Physical Activity Questionnaire	Change at 3 and 6 months (from Baseline) in physical activity levels between the two intervention groups and control. This questionnaire inquires about physical activity across four domains (leisure time, occupation, commuting, and domestic life) during the past 4 weeks. Metabolic Equivalent of Task scores can be calculated and an estimation of total energy expenditure across the four domains.	Baseline, 3 months and 6 months
Secondary	Capturing Changes in Cognition (Catch-Cog)	Change at 3 and 6 months (from baseline) in cognition using the Capturing Changes in Cognition- Catch-Cog score. This composite includes an Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) word recognition (Sub score 0-12), ADAS-Cog orientation (Sub score 0-8), Controlled Oral Word Association Test (COWAT) (max number of words in 1 minute), Category Fluency Test (max number of words in 1 minute), a Digital Symbol Substitution test (correct number of symbols matched in 90 seconds), and an ADAS-Cog Word Recall Test (sub score range: 0-10). A higher score reflects better cognitive performance.	Baseline, 3 months and 6 months
Secondary	Trail Making Tests (TMT) (Part A & B)	Change in completion time of the TMT at 3 and 6 months (from baseline). Higher time reflects greater impairment.	Baseline, 3 months and 6 months
Secondary	Delayed recall test (0-10)	Change at 3 and 6 months (from baseline) in a delayed recall test of recalled learned words after a 5-minute delay (score range 0-10)	Baseline, 3 months and 6 months
Secondary	Functional performance measured using the Short Physical Performance Battery (SPPB) test.	Change at 3 and 6 months in functional performance from baseline (using the SBBP): The SPPB will test participant's Gait (time to walk 8 feet), Balance (ability to complete a side-by-side, a semi-tandem and a tandem stand) and Strength (time to complete 5 chair stands). Category scores range from 0-4 and total score (0-12) with a higher score representing better physical functioning.	Baseline, 3 months and 6 months
Secondary	Grip Strength measured by isometric grip force (0-100kg)	Change in isometric grip force (0-100kg) at 3 and 6 months (from baseline) using a Dynamometer	Baseline, 3 months and 6 months
Secondary	Health-related quality of life (Short Form (SF)-36)	Change in health related quality of life measures at 3 and 6 months between the two intervention groups and control. The SF-36 is a 36-item questionnaire (covering 8 domains of health including physical functioning; role limitations due to physical health; role limitation due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health.Scores range from 0-100 with higher score indicating a better quality of life.	Baseline, 3 months and 6 months
Secondary	Geriatric Depression Scale	Change in Depression scale at 3 and 6 months (from baseline) Scores range from 0-15. A score =5 indicates probable depression	Baseline, 3 months and 6 months
Secondary	Systolic Blood Pressure (mmHg)	Change at 3 and 6 months (from baseline) using a Omron automated blood pressure monitor	Baseline, 3 months and 6 months
Secondary	Diastolic Blood Pressure (mmHg)	Change at 3 and 6 months (from baseline) using an Omron automated blood pressure monitor	Baseline, 3 months and 6 months
Secondary	Biochemical markers: nutritional, cardiometabolic and inflammatory	Blood sample will be collected to determine change in serum levels of Vitamin A, Vitamin E , Carotenoids (nmol/l), change in serum lipid profile (Total cholesterol, HDL cholesterol, LDL Cholesterol and triglycerides (mmol/l)), HbA1c (mmol/mol) , fasting plasma glucose (mmol/l) and Insulin (pmol/l), High Sensitivity C-Reactive Protein (mg/l), Interleukin-6 (pg/ml),at 3 and 6 months (from Baseline).	Baseline, 3 months and 6 months

External Links

•   Link to PROMED-COG consortium and trial website