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

University College Dublin

Status: Active, not recruiting

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05608707

JPI-ERA-HDHL PREVNUT-2020-1 (Other Grant/Funding Number)

LS-21-96-Roche

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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180 participants in 4 patient groups

Personalised diet plus physical activity intervention

Experimental group

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

Treatment:

Dietary Supplement: Personalised nutrition intervention

Behavioral: Physical activity intervention

Usual diet plus physical activity

Experimental group

Description:

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

Treatment:

Behavioral: Physical activity intervention

Personalised diet plus usual physical activity

Experimental group

Description:

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

Treatment:

Dietary Supplement: Personalised nutrition intervention

Control (usual diet and physical activity)

No Intervention group

Description:

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