APPETITE: Plant Protein and Exercise Solutions for the Prevention of Undernutrition in Older Adults.
NCT ID: NCT05608707
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
180 participants
INTERVENTIONAL
2022-09-22
2025-09-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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Personalised diet plus physical activity intervention
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
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.
Usual diet plus physical activity
Participants will consume their usual diet and undertake 2 weekly group exercise sessions incorporating strength and balance exercises, along with home-based exercise
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 diet plus usual physical activity
A personalised diet intervention involving the incorporation of the developed plant-based protein and fibre product.
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.
Control (usual diet and physical activity)
This arm will not be given any nutritional or physical activity support. They will be instructed to carry on with their usual activities.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
65 Years
ALL
Yes
Sponsors
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Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
OTHER
Friedrich-Alexander-Universität Erlangen-Nürnberg
OTHER
University of Padova
OTHER
University College Dublin
OTHER
Responsible Party
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Principal Investigators
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Helen M Roche, Professor
Role: PRINCIPAL_INVESTIGATOR
UCD
Katy Horner, PhD
Role: PRINCIPAL_INVESTIGATOR
University College Dublin
Marjolein Visser, PhD
Role: PRINCIPAL_INVESTIGATOR
VU Amsterdam
Locations
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FAU
Nuremberg, , Germany
School of Public Health, Physiotherapy and Sports Science
Dublin, Leinster, Ireland
UNIPD
Padua, , Italy
Countries
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References
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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.
Related Links
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Study specific website
Study protocol paper
Other Identifiers
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JPI-ERA-HDHL PREVNUT-2020-1
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
LS-21-96-Roche
Identifier Type: -
Identifier Source: org_study_id