Effect of a Novel Protein Supplement on Appetite in Older Adults

NCT ID: NCT05871060

Last Updated: 2023-11-27

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

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-25

Study Completion Date

2023-10-30

Brief Summary

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An acute randomized crossover trial comparing the effects of the whey hydrolysate, whey protein concentrate and placebo (still flavored water) on appetite and energy intake in older adults. Both low-dose whey-derived treatment and placebo will be administered 30 minutes prior to breakfast and lunch meals. Moreover, ghrelin secretion and activity will be monitored throughout the morning until the lunch time. Appetite will be assessed through visual analogue scale questionnaires.

Detailed Description

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Conditions

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Aging Appetite Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Out of three treatments, the investigator is blinded for two of them (pre-labelled as A and B).

The participant is fully blinded, i.e. treatments will be served in black cups and vanilla-flavoured.

Study Groups

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whey concentrate supplement

2,2 grams of whey concentrate dissolved in 100 mL of water

Group Type ACTIVE_COMPARATOR

Whey Protein Concentrate

Intervention Type DIETARY_SUPPLEMENT

Whey protein concentrate consumed 30 minutes prior to breakfast and lunch meals

whey hydrolysate supplement

2,2 grams of whey hydrolysate dissolved in 100 mL of water

Group Type EXPERIMENTAL

Whey hydrolysate

Intervention Type DIETARY_SUPPLEMENT

Whey hydrolysate consumed 30 minutes prior to breakfast and lunch meals

still flavoured water

100 mL of vanilla-flavoured water

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Flavoured water consumed 30 minutes prior to breakfast and lunch meals

Interventions

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Whey Protein Concentrate

Whey protein concentrate consumed 30 minutes prior to breakfast and lunch meals

Intervention Type DIETARY_SUPPLEMENT

Placebo

Flavoured water consumed 30 minutes prior to breakfast and lunch meals

Intervention Type DIETARY_SUPPLEMENT

Whey hydrolysate

Whey hydrolysate consumed 30 minutes prior to breakfast and lunch meals

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

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

60 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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TC201800025

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

LS-22-64-Horner

Identifier Type: -

Identifier Source: org_study_id