NCT05608707

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

Innovative PlAnt Protein Fibre and Physical Activity Solutions to Address Poor AppEtite and PrevenT UndernutrITion in OldEr Adults (APPETITE)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: University College Dublin · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	Physical activity intervention	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.
DIETARY_SUPPLEMENT	Personalised nutrition intervention	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.

Timeline

• Start date: 2022-09-22
• Primary completion: 2024-07-17
• Completion: 2025-09-01
• First posted: 2022-11-08
• Last updated: 2024-12-09

Locations

3 sites across 3 countries: Germany, Ireland, Italy