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

NCT05608707 | Active Not Recruiting DMC

• 2 other identifiers: LS-21-96-RocheJPI-ERA-HDHL PREVNUT-2020-1
• Study Type: interventional
• Target: 180
• Locations: 3 countries
• Sites: 3

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.

Conditions

Appetite Loss; Physical Inactivity; Undernutrition; Anorexia of Aging; Aging; Ageing Well

Keywords

appetite; energy intake; nutrition; older adults; Physical activty

Outcome Measures

Primary Outcomes (2)

• Ad libitum energy intake (kcal)

  12-week change in energy intake assessed at an an ad libitum lunch test meal

  To be assessed at baseline and following a 12-week intervention or control period

• 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').

  To be assessed at baseline and following a 12-week intervention or control period

Secondary Outcomes (25)

• 7-day physical activity score as assessed by ActivPAL v4.0

  To be assessed at baseline, prior to commencing the intervention, and during week 12 of the intervention or control period

• Resting Energy Expenditure (REE) (sub-sample)

  To be assessed at baseline and following a 12-week intervention or control period

• Handgrip strength

  To be assessed at baseline and following a 12-week intervention or control period

• Isometric knee extension strength

  To be assessed at baseline and following a 12-week intervention or control period

• Cardiorespiratory fitness

  To be assessed at baseline and following a 12-week intervention or control period

Other Outcomes (5)

• Physical Activity Scale for the Elderly (PASE)

  To be assessed at baseline and following a 12-week intervention or control period

• Adherence and acceptability of the intervention

  Throughout intervention

• Self-efficacy in adhering to the intervention

  At baseline

Study Arms (4)

Personalised diet plus physical activity intervention

EXPERIMENTAL

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

Behavioral: Physical activity intervention; Dietary Supplement: Personalised nutrition intervention

Usual diet plus physical activity

EXPERIMENTAL

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

Behavioral: Physical activity intervention

Personalised diet plus usual physical activity

EXPERIMENTAL

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

Dietary Supplement: Personalised nutrition intervention

Control (usual diet and physical activity)

NO INTERVENTION

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

Interventions

Physical activity intervention BEHAVIORAL

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.

Also known as: Structured exercise program

Personalised diet plus physical activity intervention; Usual diet plus physical activity

Personalised nutrition intervention DIETARY_SUPPLEMENT

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.

Also known as: Plant-based protein and fibre intervention

Personalised diet plus physical activity intervention; Personalised diet plus usual physical activity

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College Dublin: lead
• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: collaborator
• Friedrich-Alexander-Universität Erlangen-Nürnberg: collaborator
• University of Padova: collaborator

Study Sites (3)

FAU

Nuremberg, Germany

Location

School of Public Health, Physiotherapy and Sports Science

Dublin, Leinster, Ireland

Location

UNIPD

Padua, Italy

Location

Related Publications (1)

• 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.

  PMID: 39387205 BACKGROUND

Related Links

• Study specific website
• Study protocol paper

MeSH Terms

Conditions

Anorexia; Sedentary Behavior; Malnutrition

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Helen M Roche, Professor

  UCD

  PRINCIPAL INVESTIGATOR

• Katy Horner, PhD

  University College Dublin

  PRINCIPAL INVESTIGATOR

• Marjolein Visser, PhD

  VU Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial, a two-by-two factorial design will define the individual and combined impact of two intervention conditions over 12 weeks

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: November 8, 2022
• Study Start: September 22, 2022
• Primary Completion: July 17, 2024
• Study Completion: September 1, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); DE (1); IE (1)