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APPETITE: Plant Protein and Exercise Solutions for the Prevention of Undernutrition in Older Adults.

Primary Purpose

Appetite Loss, Physical Inactivity, Undernutrition

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Physical activity intervention
Personalised nutrition intervention
Sponsored by
University College Dublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Appetite Loss focused on measuring appetite, energy intake, nutrition, older adults, Physical activty

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Community-dwelling, Age 65+ years, BMI 19.5-30.4kg/m2, Inactive (<150 minutes of moderate to vigorous physical activity per week and no regular resistance training), Have proof of Covid-19 vaccination Exclusion Criteria: Major cognitive impairment (MMSE ≤24), Uncontrolled Clinical depression (CES-D >16), Medical condition or current medication known to impact appetite or energy intake, Other medical condition that may impact ability to participate in study or study outcomes, Heavy smoker (>10/day), Plans to relocate out of the study area within the next 6 months, Inability to come to study centre/PA program location, Currently participating in another intervention study, Inability to participate in physical activity, Unable to walk across a room, Allergic to or unwilling to consume any of the study test foods, Loss of taste or smell associated with COVID-19, Unwilling to be randomised to any intervention group.

Sites / Locations

  • INRAE
  • FAURecruiting
  • School of Public Health, Physiotherapy and Sports ScienceRecruiting
  • UNIPDRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Personalised diet plus physical activity intervention

Usual diet plus physical activity

Personalised diet plus usual physical activity

Control (usual diet and physical activity)

Arm Description

A personalised diet intervention involving the incorporation of the developed plant-based protein and fibre product. Participants will also undertake 2 weekly group exercise sessions incorporating strength and balance exercises, along with home-based exercise

Participants will consume their usual diet and undertake 2 weekly group exercise sessions incorporating strength and balance exercises, along with home-based exercise

A personalised diet intervention involving the incorporation of the developed plant-based protein and fibre product.

This arm will not be given any nutritional or physical activity support. They will be instructed to carry on with their usual activities.

Outcomes

Primary Outcome Measures

Ad libitum energy intake (kcal)
12-week change in energy intake assessed at an an ad libitum lunch test meal
Changes in subjective appetite sensations
12-week change in appetite to be assessed by Visual Analogue Scale (VAS) during a test meal challenge. The VAS is a validated tool for assessing subjective sensations such as hunger, fullness and desire to eat. On each 100-mm line, an appetite (hunger, fullness, desire to eat) sensation was paired with the opposing sensation (for example, 'hungry' and 'not hungry').

Secondary Outcome Measures

7-day physical activity score as assessed by ActivPAL v4.0
12-week change in physical activity score will be assessed using 7-day accelerometery data. This is a validated device that is installed onto an individuals thigh for continuous readings. The data generated describes the amount of time spent engaging in physical activities and sedentary activities, and gives an output score in MET.h (Metabolic EquivalenT hour). This is a measure of energy usage over and above what is required at rest, where 1MET is equivalent to oxygen uptake of 3.5ml/kg body weight/minute
Resting Energy Expenditure (REE) (sub-sample)
12-week change in resting energy expenditure will be assessed using indirect calorimetry
Handgrip strength
12-week change in handgrip strength will be assessed using a Jamar hydraulic hand dynamometer
Isometric knee extension strength
12-week changes in isometric leg strength will be assessed using a seated leg extension dynamometer
Cardiorespiratory fitness
12-week change in cardiorespiratory fitness will be assessed using the 400-meter walk test
Physical performance
12-week change in physical function will be assessed using the Short Physical Activity Battery (SPPB)
Participants subjective rating of perceived Quality of Life as assessed by the EQ-5D-5L
12-week changes in perceived quality of life will be assessed using the EuroQol (European Quality Of Life) questionnaire (EQ-5D-5L). This consists of self-assessed rating of health under 5 dimensions (Mobility, Self-Care, Usual Activity, Pain/Discomfort, Anxiety/Depression), and perceived overall health on a magnitude scale (0-100) anchored with opposing statements (0= the worst health you can imagine; 100= the best health you can imagine).
Body composition (fat mass, fat free mass) by air displacement phlethysmography (sub-sample)
12-week change in body composition will be assessed using air displacement plethysmography (Bodpod).
Cognitive Dietary Restraint
12-week change in dietary restraint will be assessed using the Cognitive Dietary Restraint (CDR) subscale of the Three Factor Eating Questionnaire (TFEQ). The questionnaire consists of a subscale of 6 questions relating to cognitive dietary restraint from the orignal 50 item questionnaire. The questions are a mix of 'true/false', and likert scale type answers.
Dietary Record (energy, protein and fibre intake)
12-week change in energy, protein and fibre intake assessed using a three-day non-weighed dietary record
Appetite hormones (Ghrelin, GLP-1, & PYY) (sub-sample)
12-week change in appetite-related gut hormone response to a fixed meal. Assessed in circulating peripheral bloods at fasting, and at regular intervals postprandially (minute 30, 60, 90, 120, 150, & 180).
Gut metabolomic profiles and gut microbiome diversity
12-week change in gut microbiota quality and diversity assessed by faecal matter and faecal water.
Blood hormone and metabolite profile
12-week change in fasting peripheral blood profile (insulin, leptin, glucose, amino acid, fatty acid)
Body composition by Bioelectrical Impedance Analysis (BIA)
Body composition will be assessed by BIA across all sites at baseline and post intervention. BIA is a quick non-invasive method of measuring body composition. Bioelectrical impedance analysis (BIA) measures body composition based on the rate at which an electrical current travels through the body. Body fat (adipose tissue) causes greater resistance (impedance) than lean mass and slows the rate at which the current travels. The device provides an output of absolute (Kg) and percentage (% of total mass) of fat mass (FM) and fat-free mass (FFM).
Appetite by Simplified Nutritional Appetite Questionnaire (SNAQ)
The SNAQ questionnaire is used to assess an older adults usual appetite. The SNAQ is a self-administered questionnaires adapted from the Appetite, Hunger and Sensory Perception questionnaire (AHSP), an appetite assessment tool validated among community-dwelling older adults. It consists of 4 multiple choice statements, where an individual reads the beginning of the statement and is presented with 5 options that best describe their situation. Each question derives a score between 1 - 5 with lower scores indicating poorer appetite. The questionnaire scores between 4 - 20 with scores </= 14 indicating poor appetite.
Test meal palatability by Visual Analogue Scale (VAS)
Rating of the breakfast and lunch test meals by visual analogue scales (VAS). The VAS is a validated tool for assessing subjective sensory experience. On each 100-mm line, a question is asked relating to sensory aspects of the meal (E.g., How pleasant was the meal?). The subject will mark along the 100mm line where they feel their experience, in terms of the question, rests. On ether end of the 100mm line are opposing terms (E.g., "not at all", "extremely").
Body weight (kg)
Body weight will be measure using a calibrated scales, shoes and heavy clothing removes, and recorded in kilograms.
Standing height (cm)
Height will be measured in centimetres using a stadiometer. Participants will be measured barefoot and asked to take a full inhalation prior to stepping out from the device. Measurements are taken at the peak of the inhalation.
Calf circumference (cm)
Calf circumference is measures using a non-stretch tape measure at the widest part of the calf muscle and recorded in centimetres.
Perception and evaluation of the trial
Questionnaire specific to the project. This questionnaire will serve to provide feedback about participants experience while enrolled on the project. The questionnaire will include a series of Likert style questions and open-ended questions. The purpose is the provide feedback to the study team on what participants liked or disliked about the experience. This will serve to inform future management of studies.
Body composition by Dual-energy X-ray absorptiometry (DXA) (sub-sample)
DXA will be performed on a sub-sample of participants enrolled on the APPETITE study. A DXA can involves a large scanning arm being passed over the body to measure compartments of the body structure. As the scanning arm is moved slowly over your body, a narrow beam of low-dose X-rays will be passed through the part of your body being examined. DXA is a quick and non-invasive scan that provides in-depth analysis of the main components of your body; fat, muscle and bone.
Motor Unit Signalling (sub-sample)
by electromyography (EMG)
Motor Unit Number
from muscle biopsy
muscle signalling related to muscle plasticity, metabolism, denervation and muscle capillarization (sub-sample)
This refers to the analyses of muscle biopsies. Biopsies will be taken using MEDAX/BF14100-C0; Bio-Feather with coaxial 14 g 10 cm. The following parameters will then be measured in the sample using western blot with specific antibodies for total proteins or by their activated phosphorylated form: 1) markers of denervation (AChR ; agrin/MuSK/Lrp4, NCAM, Myog); 2) markers of protein turnover (atrogin1, MURF1, LC3, BNIP3, Akt-dependent mTOR and FoxO); 3) markers of mitochondrial dynamics (OPA1, DRP1) and; 4) markers of energy metabolism pathways (AMPK and PGC1alpha).
Innate immune training of macrophages
Trained immunity describes the long-term functional reprogramming of innate immune cells after exposure to a primary insult which leads to an augmented response upon stimulation with the same ligand after returning to a non-activated state. Will habitual ingestion of plant protein combined with PA results in increased ability of macrophages to undertake innate immune train in adults over the age of 65. Effects will be quantified by comparing the presence of TNF alpha in human monocytes at baseline and following a 12-week intervention.

Full Information

First Posted
October 10, 2022
Last Updated
September 27, 2023
Sponsor
University College Dublin
Collaborators
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Friedrich-Alexander-Universität Erlangen-Nürnberg, University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT05608707
Brief Title
APPETITE: Plant Protein and Exercise Solutions for the Prevention of Undernutrition in Older Adults.
Official Title
Innovative plAnt Protein Fibre and Physical Activity Solutions to Address Poor appEtite and prevenT undernutrITion in oldEr Adults (APPETITE)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2022 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College Dublin
Collaborators
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Friedrich-Alexander-Universität Erlangen-Nürnberg, University of Padova

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The APPETITE Trial aims to investigate the efficacy of innovative plant protein fibre (PPF) products (developed in a previous workpackage) as part of a personalised diet with/out physical activity on appetite and incidence of undernutrition in older persons from three European countries at high risk of undernutrition.
Detailed Description
It is normal that dietary intake decreases as we age due to reduced activity and muscle mass. However, appetite is a key determinant of dietary intake, and poor appetite can result in undernutrition. In many instances, older adults do not recognise their appetite has decreased significantly as the decline is slow and progressive. Protein and fibre are often poorly consumed in the diets of older adults with decreased appetite, but essential for health and well-being. Interventions designed to increase appetite, or increase dietary intake despite a reduced appetite, should therefore be key to preventing undernutrition (i.e. protein-energy malnutrition as well as nutrient deficiencies). However, treatment strategies for poor appetite are not well-established. In this multi-centre randomised controlled trial conducted in Ireland, Germany, and Italy, a two-by-two factorial design will define the individual and combined impact of two intervention conditions over 12 weeks: 1) personalised diet with focus on plant-based protein plus fibre; and 2) physical activity. At each centre, 60 older adults (180 in total) will be randomly allocated to one of the following four groups over a 12 week period: 1) personalised diet plus physical activity program (PD + PA), 2) usual diet plus physical activity (PA), 3) personalised diet and no PA (PD), and 4) control (usual diet, no PA). Using identical procedures, two testing visits will be completed before and after the 12 intervention or control period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appetite Loss, Physical Inactivity, Undernutrition, Anorexia of Aging, Aging, Ageing Well
Keywords
appetite, energy intake, nutrition, older adults, Physical activty

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Randomised controlled trial, a two-by-two factorial design will define the individual and combined impact of two intervention conditions over 12 weeks
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personalised diet plus physical activity intervention
Arm Type
Experimental
Arm Description
A personalised diet intervention involving the incorporation of the developed plant-based protein and fibre product. Participants will also undertake 2 weekly group exercise sessions incorporating strength and balance exercises, along with home-based exercise
Arm Title
Usual diet plus physical activity
Arm Type
Experimental
Arm Description
Participants will consume their usual diet and undertake 2 weekly group exercise sessions incorporating strength and balance exercises, along with home-based exercise
Arm Title
Personalised diet plus usual physical activity
Arm Type
Experimental
Arm Description
A personalised diet intervention involving the incorporation of the developed plant-based protein and fibre product.
Arm Title
Control (usual diet and physical activity)
Arm Type
No Intervention
Arm Description
This arm will not be given any nutritional or physical activity support. They will be instructed to carry on with their usual activities.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity intervention
Other Intervention Name(s)
Structured exercise program
Intervention Description
The 12 week intervention will involve 2 weekly group exercise sessions incorporating strength and balance exercises, along with home-based exercise focused on increasing time spent walking.
Intervention Type
Dietary Supplement
Intervention Name(s)
Personalised nutrition intervention
Other Intervention Name(s)
Plant-based protein and fibre intervention
Intervention Description
Two Plant-based Protein and Fibre (PPF) product products have been selected from six initially developed, with best amino acid blend, taste, and bioavailability. Participants will be provided with the PPFs to consume daily as part of a personalised diet over 12 weeks.
Primary Outcome Measure Information:
Title
Ad libitum energy intake (kcal)
Description
12-week change in energy intake assessed at an an ad libitum lunch test meal
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Changes in subjective appetite sensations
Description
12-week change in appetite to be assessed by Visual Analogue Scale (VAS) during a test meal challenge. The VAS is a validated tool for assessing subjective sensations such as hunger, fullness and desire to eat. On each 100-mm line, an appetite (hunger, fullness, desire to eat) sensation was paired with the opposing sensation (for example, 'hungry' and 'not hungry').
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Secondary Outcome Measure Information:
Title
7-day physical activity score as assessed by ActivPAL v4.0
Description
12-week change in physical activity score will be assessed using 7-day accelerometery data. This is a validated device that is installed onto an individuals thigh for continuous readings. The data generated describes the amount of time spent engaging in physical activities and sedentary activities, and gives an output score in MET.h (Metabolic EquivalenT hour). This is a measure of energy usage over and above what is required at rest, where 1MET is equivalent to oxygen uptake of 3.5ml/kg body weight/minute
Time Frame
To be assessed at baseline, prior to commencing the intervention, and during week 12 of the intervention or control period
Title
Resting Energy Expenditure (REE) (sub-sample)
Description
12-week change in resting energy expenditure will be assessed using indirect calorimetry
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Handgrip strength
Description
12-week change in handgrip strength will be assessed using a Jamar hydraulic hand dynamometer
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Isometric knee extension strength
Description
12-week changes in isometric leg strength will be assessed using a seated leg extension dynamometer
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Cardiorespiratory fitness
Description
12-week change in cardiorespiratory fitness will be assessed using the 400-meter walk test
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Physical performance
Description
12-week change in physical function will be assessed using the Short Physical Activity Battery (SPPB)
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Participants subjective rating of perceived Quality of Life as assessed by the EQ-5D-5L
Description
12-week changes in perceived quality of life will be assessed using the EuroQol (European Quality Of Life) questionnaire (EQ-5D-5L). This consists of self-assessed rating of health under 5 dimensions (Mobility, Self-Care, Usual Activity, Pain/Discomfort, Anxiety/Depression), and perceived overall health on a magnitude scale (0-100) anchored with opposing statements (0= the worst health you can imagine; 100= the best health you can imagine).
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Body composition (fat mass, fat free mass) by air displacement phlethysmography (sub-sample)
Description
12-week change in body composition will be assessed using air displacement plethysmography (Bodpod).
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Cognitive Dietary Restraint
Description
12-week change in dietary restraint will be assessed using the Cognitive Dietary Restraint (CDR) subscale of the Three Factor Eating Questionnaire (TFEQ). The questionnaire consists of a subscale of 6 questions relating to cognitive dietary restraint from the orignal 50 item questionnaire. The questions are a mix of 'true/false', and likert scale type answers.
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Dietary Record (energy, protein and fibre intake)
Description
12-week change in energy, protein and fibre intake assessed using a three-day non-weighed dietary record
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Appetite hormones (Ghrelin, GLP-1, & PYY) (sub-sample)
Description
12-week change in appetite-related gut hormone response to a fixed meal. Assessed in circulating peripheral bloods at fasting, and at regular intervals postprandially (minute 30, 60, 90, 120, 150, & 180).
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Gut metabolomic profiles and gut microbiome diversity
Description
12-week change in gut microbiota quality and diversity assessed by faecal matter and faecal water.
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Blood hormone and metabolite profile
Description
12-week change in fasting peripheral blood profile (insulin, leptin, glucose, amino acid, fatty acid)
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Body composition by Bioelectrical Impedance Analysis (BIA)
Description
Body composition will be assessed by BIA across all sites at baseline and post intervention. BIA is a quick non-invasive method of measuring body composition. Bioelectrical impedance analysis (BIA) measures body composition based on the rate at which an electrical current travels through the body. Body fat (adipose tissue) causes greater resistance (impedance) than lean mass and slows the rate at which the current travels. The device provides an output of absolute (Kg) and percentage (% of total mass) of fat mass (FM) and fat-free mass (FFM).
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Appetite by Simplified Nutritional Appetite Questionnaire (SNAQ)
Description
The SNAQ questionnaire is used to assess an older adults usual appetite. The SNAQ is a self-administered questionnaires adapted from the Appetite, Hunger and Sensory Perception questionnaire (AHSP), an appetite assessment tool validated among community-dwelling older adults. It consists of 4 multiple choice statements, where an individual reads the beginning of the statement and is presented with 5 options that best describe their situation. Each question derives a score between 1 - 5 with lower scores indicating poorer appetite. The questionnaire scores between 4 - 20 with scores </= 14 indicating poor appetite.
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Test meal palatability by Visual Analogue Scale (VAS)
Description
Rating of the breakfast and lunch test meals by visual analogue scales (VAS). The VAS is a validated tool for assessing subjective sensory experience. On each 100-mm line, a question is asked relating to sensory aspects of the meal (E.g., How pleasant was the meal?). The subject will mark along the 100mm line where they feel their experience, in terms of the question, rests. On ether end of the 100mm line are opposing terms (E.g., "not at all", "extremely").
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Body weight (kg)
Description
Body weight will be measure using a calibrated scales, shoes and heavy clothing removes, and recorded in kilograms.
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Standing height (cm)
Description
Height will be measured in centimetres using a stadiometer. Participants will be measured barefoot and asked to take a full inhalation prior to stepping out from the device. Measurements are taken at the peak of the inhalation.
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Calf circumference (cm)
Description
Calf circumference is measures using a non-stretch tape measure at the widest part of the calf muscle and recorded in centimetres.
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Perception and evaluation of the trial
Description
Questionnaire specific to the project. This questionnaire will serve to provide feedback about participants experience while enrolled on the project. The questionnaire will include a series of Likert style questions and open-ended questions. The purpose is the provide feedback to the study team on what participants liked or disliked about the experience. This will serve to inform future management of studies.
Time Frame
End of trial (up to 18-weeks)
Title
Body composition by Dual-energy X-ray absorptiometry (DXA) (sub-sample)
Description
DXA will be performed on a sub-sample of participants enrolled on the APPETITE study. A DXA can involves a large scanning arm being passed over the body to measure compartments of the body structure. As the scanning arm is moved slowly over your body, a narrow beam of low-dose X-rays will be passed through the part of your body being examined. DXA is a quick and non-invasive scan that provides in-depth analysis of the main components of your body; fat, muscle and bone.
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Motor Unit Signalling (sub-sample)
Description
by electromyography (EMG)
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Motor Unit Number
Description
from muscle biopsy
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
muscle signalling related to muscle plasticity, metabolism, denervation and muscle capillarization (sub-sample)
Description
This refers to the analyses of muscle biopsies. Biopsies will be taken using MEDAX/BF14100-C0; Bio-Feather with coaxial 14 g 10 cm. The following parameters will then be measured in the sample using western blot with specific antibodies for total proteins or by their activated phosphorylated form: 1) markers of denervation (AChR ; agrin/MuSK/Lrp4, NCAM, Myog); 2) markers of protein turnover (atrogin1, MURF1, LC3, BNIP3, Akt-dependent mTOR and FoxO); 3) markers of mitochondrial dynamics (OPA1, DRP1) and; 4) markers of energy metabolism pathways (AMPK and PGC1alpha).
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Innate immune training of macrophages
Description
Trained immunity describes the long-term functional reprogramming of innate immune cells after exposure to a primary insult which leads to an augmented response upon stimulation with the same ligand after returning to a non-activated state. Will habitual ingestion of plant protein combined with PA results in increased ability of macrophages to undertake innate immune train in adults over the age of 65. Effects will be quantified by comparing the presence of TNF alpha in human monocytes at baseline and following a 12-week intervention.
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Other Pre-specified Outcome Measures:
Title
Physical Activity Scale for the Elderly (PASE)
Description
Physical Activity Scale for the Elderly (PASE) is a brief (5 minutes) and easily scored survey designed specifically to assess physical activity in epidemiological studies of persons age 65 years and older
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Adherence and acceptability of the intervention
Description
Adherence to the intervention requirements will be assessed using compliance diaries. Participants will record in a diary, provided by the study team, each time they consume the study product and/or complete a physical activity session. They will also collect empty sachets and return them to the study team at the end of the intervention. Compliance is considered adequate if 10 of a possible 14 supplements per week are consumed, and/or attendance of >80% structured physcial activity sessions.
Time Frame
Throughout intervention
Title
Self-efficacy in adhering to the intervention
Description
This will take the form of a couple of questions during initial screening. The purpose of these questions is to assess whether the participant believes they can fulfil the intervention requirements if enrolled onto the study. The logic is to identify those who are unlikely to complete the study as a mechanism of reducing dropout rates. The questions will take the form of a Likert scale, and relate to the participants confidence, or lack thereof, to complete key requirements of the study.
Time Frame
At baseline
Title
Cognitive status by Mini Mental State Examination (MMSE)
Description
12-week change in global cognition assessed by Mini Mental State Examination (MMSE). The MMSE is a commonly used tool to exam global cognition in both clinical and research setting. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score for the MMSE is 30 points, where scores <24 would be indicative of cognitive dysfunction.
Time Frame
To be assessed at baseline and following a 12-week intervention or control period
Title
Depressive symptoms assessed by Centre of Epidemiology Study - Depression (CES-D)
Description
12-week change in depressive (Centre of Epidemiology Study - Depression) symptoms. The CES-D is a 20-item measure that rate how often over the past week an individual experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. A score equal to or greater than 16 is indicative of risk of clinical depression.
Time Frame
To be assessed at baseline and following a 12-week intervention or control period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Community-dwelling, Age 65+ years, BMI 19.5-30.4kg/m2, Inactive (<150 minutes of moderate to vigorous physical activity per week and no regular resistance training), Have proof of Covid-19 vaccination Exclusion Criteria: Major cognitive impairment (MMSE ≤24), Uncontrolled Clinical depression (CES-D >16), Medical condition or current medication known to impact appetite or energy intake, Other medical condition that may impact ability to participate in study or study outcomes, Heavy smoker (>10/day), Plans to relocate out of the study area within the next 6 months, Inability to come to study centre/PA program location, Currently participating in another intervention study, Inability to participate in physical activity, Unable to walk across a room, Allergic to or unwilling to consume any of the study test foods, Loss of taste or smell associated with COVID-19, Unwilling to be randomised to any intervention group.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helen M Roche, Professor
Phone
01 716 6845
Email
helen.roche@ucd.ie
First Name & Middle Initial & Last Name or Official Title & Degree
Katy M Horner, Dr
Phone
01 716 3439
Email
katy.horner@ucd.ie
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen M Roche, Professor
Organizational Affiliation
UCD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katy Horner, PhD
Organizational Affiliation
University College Dublin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marjolein Visser, PhD
Organizational Affiliation
VU Amsterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
INRAE
City
Clermont-Ferrand
Country
France
Individual Site Status
Withdrawn
Facility Name
FAU
City
Nuremberg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorothee Volkert, PhD
First Name & Middle Initial & Last Name & Degree
Pia Scheufele, Ms
First Name & Middle Initial & Last Name & Degree
Susanne Muck, Ms
First Name & Middle Initial & Last Name & Degree
Elena Hamers, Ms
Facility Name
School of Public Health, Physiotherapy and Sports Science
City
Dublin
State/Province
Leinster
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen M Roche, Prof
Phone
01 716 6845
Email
helen.roche@ucd.ie
First Name & Middle Initial & Last Name & Degree
Katy M Horner, Dr
Phone
01 716 3439
Email
katy.horner@ucd.ie
First Name & Middle Initial & Last Name & Degree
Brian Mullen, Mr
First Name & Middle Initial & Last Name & Degree
Anna Quinn, Ms
First Name & Middle Initial & Last Name & Degree
Wiktoria Sala, Ms
First Name & Middle Initial & Last Name & Degree
Clare Corish, Prof
First Name & Middle Initial & Last Name & Degree
Victoria Sherwood, Ms
First Name & Middle Initial & Last Name & Degree
Yuzhu Zhou, Mr
Facility Name
UNIPD
City
Padova
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe De Vito, PhD
First Name & Middle Initial & Last Name & Degree
Federica Gonnelli, Ms
First Name & Middle Initial & Last Name & Degree
Matteo Bozzato, Mr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Volkert D, et al. Innovative plAnt Protein fibre and Physical activity solutions to address poor appEtite and prevenT undernutrITion in oldEr adults - APPETITE. Nutrition Bulletin. 2021; 46: 486-496
Results Reference
background

Learn more about this trial

APPETITE: Plant Protein and Exercise Solutions for the Prevention of Undernutrition in Older Adults.

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