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Clinical Trials in Germany / NCT05608707
Active, not recruiting Not applicable

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

NCT05608707 · tracked via the Priya Life Science Germany tracker
Sponsor
University College Dublin
Phase
Not applicable
Started
2022-09-22
Last updated
2024-12-09

Condition(s) studied

Appetite LossPhysical InactivityUndernutritionAnorexia of AgingAgingAgeing Well

Investigational drug(s) / intervention(s)

Physical activity interventionPersonalised nutrition intervention

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
Accepted
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 outcome measure(s)

  • Ad libitum energy intake (kcal) — To be assessed at baseline and following a 12-week intervention or control period
    12-week change in energy intake assessed at an an ad libitum lunch test meal
  • Changes in subjective appetite sensations — To be assessed at baseline and following a 12-week intervention or control period
    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').

Trial sites (3)

FacilityCityRegionStatus
FAU Nuremberg Germany
School of Public Health, Physiotherapy and Sports Science Dublin Leinster
UNIPD Padova Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05608707 on ClinicalTrials.gov ↗ ← All trials in Germany