Effect of a Novel Protein Ingredient Combined With Oral Nutritional Supplement on Appetite in Older Adults

NCT ID: NCT06478147

Last Updated: 2024-06-27

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-02

Study Completion Date

2024-06-29

Brief Summary

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Reduced appetite can occur with ageing and is linked to a higher risk of undernutrition, poorer physical function and becoming frail. Strategies to increase appetite are needed to improve healthy ageing. This study follows on from previous work which has found a novel ingredient in whey protein (derived from whole milk) that may help to increase appetite and energy intake. This study will compare the effects of the ingredient added to an oral nutritional supplement (ONS) versus the ONS alone versus the ingredient dissolved in water on appetite in older adults. By studying this nutrition supplement in older adults, this will help to provide greater information on possible nutrition strategies to improve healthy ageing.

Detailed Description

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Conditions

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Aging Appetite Loss Undernutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover Assignment

All participants undertake all three experimental conditions in a random order.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Out of three treatments, one of the investigators is blinded for all treatments while the other is not blinded.

The participant is fully blinded, i.e. treatments will be served in generic containers for Oral Nutritional Supplement (unlabelled) and vanilla-flavoured.

Study Groups

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Oral Nutritional Supplement

125 mL of commercially available of Oral Nutritional Supplement, a liquid food product containing vitamins, minerals, protein, fats and carbohydrates. 125 mL of product provides 37.0 g of carbohydrates, 11.6 g of fats, 12.0 g of proteins, vitamins and minerals.

Group Type PLACEBO_COMPARATOR

Oral Nutritional Supplement

Intervention Type DIETARY_SUPPLEMENT

Commercially available Oral Nutritional Supplement alone consumed 90 minutes prior to an ad libitum breakfast

Oral Nutritional Supplement + Whey Protein Hydrolysate

2,2 grams of whey protein hydrolysate dissolved in 125 mL of commercially available of Oral Nutritional Supplement

Group Type EXPERIMENTAL

Oral Nutritional Supplement + Whey Protein Hydrolysate

Intervention Type DIETARY_SUPPLEMENT

Whey Protein Hydrolysate dissolved in an Oral Nutritional Supplement consumed 90 minutes prior to an ad libitum breakfast

Whey Protein Hydrolysate

2,2 grams of whey protein hydrolysate dissolved in 125 mL of water

Group Type ACTIVE_COMPARATOR

Whey Protein Hydrolysate + still water

Intervention Type DIETARY_SUPPLEMENT

Whey Protein Hydrolysate dissolved in still water consumed 90 minutes prior to an ad libitum breakfast

Interventions

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Oral Nutritional Supplement

Commercially available Oral Nutritional Supplement alone consumed 90 minutes prior to an ad libitum breakfast

Intervention Type DIETARY_SUPPLEMENT

Oral Nutritional Supplement + Whey Protein Hydrolysate

Whey Protein Hydrolysate dissolved in an Oral Nutritional Supplement consumed 90 minutes prior to an ad libitum breakfast

Intervention Type DIETARY_SUPPLEMENT

Whey Protein Hydrolysate + still water

Whey Protein Hydrolysate dissolved in still water consumed 90 minutes prior to an ad libitum breakfast

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Community-dwelling,
* Age 60+ years
* Poor appetite (Simplified Nutritional Appetite Questionnaire (SNAQ) score \</=14, answer a, b or c to Q.1 on SNAQ or answer b, c, or d to CES-D question regarding poor appetite in the past week)
* BMI 20-25kg/m2

Exclusion Criteria

* Current medical condition or medication known to impact appetite or energy intake
* Other medical condition that would impact study participation and outcomes, as judged by the study investigator.
* Heavy smoker (\>10/day)
* Inability to come to study centre
* Currently participating in another intervention study
* Lacking informed consent
* Allergic to or unwilling to consume any of the study test foods
* Loss of taste or smell associated with COVID-19
* Unable to walk across a room
Minimum Eligible Age

60 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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FHI 360

OTHER

Sponsor Role collaborator

University College Dublin

OTHER

Sponsor Role lead

Responsible Party

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Katy Horner

Lecturer in Sport and Exercise Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University College Dublin

Dublin, Leinster, Ireland

Site Status

Countries

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Ireland

Other Identifiers

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LS-22-64-Horner#2

Identifier Type: -

Identifier Source: org_study_id

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