Clinical trial NCT05608707: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Appetite Loss
Physical Inactivity
Undernutrition
Anorexia of Aging
Aging
Ageing Well
Keywords: appetite
energy intake
nutrition
older adults
Physical activty
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
name: Friedrich-Alexander-Universität Erlangen-Nürnberg
name: University of Padova
First posted: 2022-11-08
Enrollment: 180
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Ad libitum energy intake (kcal)
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Changes in subjective appetite sensations
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
Secondary outcomes:
measure: 7-day physical activity score as assessed by ActivPAL v4.0
timeFrame: To be assessed at baseline, prior to commencing the intervention, and during week 12 of the intervention or control period
measure: Resting Energy Expenditure (REE) (sub-sample)
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Handgrip strength
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Isometric knee extension strength
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Cardiorespiratory fitness
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Physical performance
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Participants subjective rating of perceived Quality of Life as assessed by the EQ-5D-5L
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Body composition (fat mass, fat free mass) by air displacement phlethysmography (sub-sample)
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Cognitive Dietary Restraint
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Dietary Record (energy, protein and fibre intake)
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Appetite hormones (Ghrelin, GLP-1, & PYY) (sub-sample)
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Gut metabolomic profiles and gut microbiome diversity
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Blood hormone and metabolite profile
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Body composition by Bioelectrical Impedance Analysis (BIA)
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Appetite by Simplified Nutritional Appetite Questionnaire (SNAQ)
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Test meal palatability by Visual Analogue Scale (VAS)
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Body weight (kg)
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Standing height (cm)
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Calf circumference (cm)
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Perception and evaluation of the trial
timeFrame: End of trial (up to 18-weeks)
measure: Body composition by Dual-energy X-ray absorptiometry (DXA) (sub-sample)
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Motor Unit Signalling (sub-sample)
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Motor Unit Number
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: muscle signalling related to muscle plasticity, metabolism, denervation and muscle capillarization (sub-sample)
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Innate immune training of macrophages
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
Other outcomes:
measure: Physical Activity Scale for the Elderly (PASE)
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Adherence and acceptability of the intervention
timeFrame: Throughout intervention
measure: Self-efficacy in adhering to the intervention
timeFrame: At baseline
measure: Cognitive status by Mini Mental State Examination (MMSE)
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
measure: Depressive symptoms assessed by Centre of Epidemiology Study - Depression (CES-D)
timeFrame: To be assessed at baseline and following a 12-week intervention or control period
Locations:
city: Nuremberg
country: Germany
facility: FAU
city: Dublin
country: Ireland
facility: School of Public Health, Physiotherapy and Sports Science
state: Leinster
city: Padova
country: Italy
facility: UNIPD
Study officials:
affiliation: UCD
name: Helen M Roche, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University College Dublin
name: Katy Horner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: VU Amsterdam
name: Marjolein Visser, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Horner KM, Mullen B, Quinn A, Scheufele P, Gola S, Gonnelli F, Bozzato M, Pratt J, Sala W, Mullin S, Kirwan L, Dardevet D, Guillet C, De Vito G, Visser M, Volkert D, Corish CA. Plant protein, fibre and physical activity solutions to address poor appetite and prevent undernutrition in older adults: study protocol for the APPETITE randomised controlled trial. Br J Nutr. 2024 Sep 28;132(6):823-834. doi: 10.1017/S0007114524002125. Epub 2024 Oct 10.