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Effect of a Novel Protein Supplement on Appetite in Older Adults

Primary Purpose

Aging, Appetite Loss

Status
Recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Whey Protein Concentrate
Placebo
Whey hydrolysate
Sponsored by
University College Dublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aging focused on measuring Appetite, Poor Appetite, Ageing, Whey protein hydrolysate, Visual analogue scale, Energy intake, Ghrelin

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University College DublinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

whey concentrate supplement

whey hydrolysate supplement

still flavoured water

Arm Description

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

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

100 mL of vanilla-flavoured water

Outcomes

Primary Outcome Measures

Pre-meal and changes in Composite Appetite Score
Validated 100 millimetre Visual Analogue Scales (VAS) will be used to assess appetite, at fourteen (14) set time points throughout the experimental visit. This VAS has anchors located at each end of the scale. On the left end of the scale, the extreme negative response (0 mm) is represented, while the right end (100 mm) represents the positive response. Participants mark along the line where it most represents their subjective perception between both ends. Composite Appetite Score is derived from VAS ratings of hunger, fullness, desire to eat and prospective food consumption.
Energy intake (EI) (kilocalories)
24-hour energy intake measurement. Participants will be served a standardised fixed breakfast and ad libitum lunch and dinner meals in the laboratory and provided with an evening snack box. 24 hour EI (kilocalories) will be measured objectively, by weighing foods before and after consumption and calculating energy intake based on their nutritional data. Total accumulated energy intake includes standard breakfast meal, ad libitum lunch meal, ad libitum dinner meal and bag with known foods for the evening time.

Secondary Outcome Measures

Palatability - Pleasantness
100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the positive response. Participants mark along the line where it most represents their subjective perception between both ends.
Palatability - Filling
100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the positive response. Participants mark along the line where it most represents their subjective perception between both ends.
Palatability - Satisfaction
100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the positive response. Participants mark along the line where it most represents their subjective perception between both ends.
Palatability - Taste
100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the positive response. Participants mark along the line where it most represents their subjective perception between both ends.
Palatability - Sweet
100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the positive response. Participants mark along the line where it most represents their subjective perception between both ends.
Palatability - Savoury
100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the positive response. Participants mark along the line where it most represents their subjective perception between both ends.
Pre-meal and changes in glucose
Blood samples will be collected by a trained phlebotomist via cannula.
Pre-meal and changes in insulin
Blood samples will be collected by a trained phlebotomist via cannula.
Pre-meal and changes in growth hormone
Blood samples will be collected by a trained phlebotomist via cannula.
Pre-meal and changes in cortisol
Blood samples will be collected by a trained phlebotomist via cannula.
Pre-meal and changes in GLP-1
Blood samples will be collected by a trained phlebotomist via cannula.
Pre-meal and changes in PYY
Blood samples will be collected by a trained phlebotomist via cannula.
Pre-meal and changes in Total Ghrelin
Blood samples will be collected by a trained phlebotomist via cannula.
Pre-meal and changes in Acylated Ghrelin
Blood samples will be collected by a trained phlebotomist via cannula.
Pre-meal and changes in Hunger
Validated 100 mm Visual Analogue Scales (VAS) will be used to estimate changes in appetite, assessed at fourteen (14) set time points throughout the experimental visit. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the extreme positive response. Participants mark along the line where it most represents their subjective perception between both ends. Composite Appetite Score derived from aspects such as hunger, fullness, desire to eat and prospective food consumption will be calculated. Fasting, mean and AUC values will be calculated.
Pre-meal and changes in Fullness
Validated 100 mm Visual Analogue Scales (VAS) will be used to estimate changes in appetite, assessed at fourteen (14) set time points throughout the experimental visit. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the extreme positive response. Participants mark along the line where it most represents their subjective perception between both ends. Composite Appetite Score derived from aspects such as hunger, fullness, desire to eat and prospective food consumption will be calculated. Fasting, mean and AUC values will be calculated.
Pre-meal and changes in Desire to Eat
Validated 100 mm Visual Analogue Scales (VAS) will be used to estimate changes in appetite, assessed at fourteen (14) set time points throughout the experimental visit. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the extreme positive response. Participants mark along the line where it most represents their subjective perception between both ends. Composite Appetite Score derived from aspects such as hunger, fullness, desire to eat and prospective food consumption will be calculated. Fasting, mean and AUC values will be calculated.
Pre-meal and changes in Prospective Food Consumption
Validated 100 mm Visual Analogue Scales (VAS) will be used to estimate changes in appetite, assessed at fourteen (14) set time points throughout the experimental visit. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the extreme positive response. Participants mark along the line where it most represents their subjective perception between both ends. Composite Appetite Score derived from aspects such as hunger, fullness, desire to eat and prospective food consumption will be calculated. Fasting, mean and AUC values will be calculated.
Liking of test meals
9-point likert scale from 0 dislike extremely to 9 like extremely

Full Information

First Posted
March 31, 2023
Last Updated
May 13, 2023
Sponsor
University College Dublin
Collaborators
FHI 360
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1. Study Identification

Unique Protocol Identification Number
NCT05871060
Brief Title
Effect of a Novel Protein Supplement on Appetite in Older Adults
Official Title
Effect of a Novel Protein Supplement on Appetite in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Dublin
Collaborators
FHI 360

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Appetite Loss
Keywords
Appetite, Poor Appetite, Ageing, Whey protein hydrolysate, Visual analogue scale, Energy intake, Ghrelin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
All participants undertake all three experimental conditions in a random order.
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
whey concentrate supplement
Arm Type
Active Comparator
Arm Description
2,2 grams of whey concentrate dissolved in 100 mL of water
Arm Title
whey hydrolysate supplement
Arm Type
Experimental
Arm Description
2,2 grams of whey hydrolysate dissolved in 100 mL of water
Arm Title
still flavoured water
Arm Type
Placebo Comparator
Arm Description
100 mL of vanilla-flavoured water
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey Protein Concentrate
Intervention Description
Whey protein concentrate consumed 30 minutes prior to breakfast and lunch meals
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Flavoured water consumed 30 minutes prior to breakfast and lunch meals
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey hydrolysate
Intervention Description
Whey hydrolysate consumed 30 minutes prior to breakfast and lunch meals
Primary Outcome Measure Information:
Title
Pre-meal and changes in Composite Appetite Score
Description
Validated 100 millimetre Visual Analogue Scales (VAS) will be used to assess appetite, at fourteen (14) set time points throughout the experimental visit. This VAS has anchors located at each end of the scale. On the left end of the scale, the extreme negative response (0 mm) is represented, while the right end (100 mm) represents the positive response. Participants mark along the line where it most represents their subjective perception between both ends. Composite Appetite Score is derived from VAS ratings of hunger, fullness, desire to eat and prospective food consumption.
Time Frame
8.5 hours: fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes after ingestion of supplement and a standard meal; at 30, 60, 120 and 180 minutes following ingestion of supplement and lunch test meal. And immediately after each test meal.
Title
Energy intake (EI) (kilocalories)
Description
24-hour energy intake measurement. Participants will be served a standardised fixed breakfast and ad libitum lunch and dinner meals in the laboratory and provided with an evening snack box. 24 hour EI (kilocalories) will be measured objectively, by weighing foods before and after consumption and calculating energy intake based on their nutritional data. Total accumulated energy intake includes standard breakfast meal, ad libitum lunch meal, ad libitum dinner meal and bag with known foods for the evening time.
Time Frame
24 hours from breakfast, lunch and dinner meals, as well as from evening and night from provided snackbox.
Secondary Outcome Measure Information:
Title
Palatability - Pleasantness
Description
100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the positive response. Participants mark along the line where it most represents their subjective perception between both ends.
Time Frame
Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Title
Palatability - Filling
Description
100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the positive response. Participants mark along the line where it most represents their subjective perception between both ends.
Time Frame
Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Title
Palatability - Satisfaction
Description
100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the positive response. Participants mark along the line where it most represents their subjective perception between both ends.
Time Frame
Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Title
Palatability - Taste
Description
100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the positive response. Participants mark along the line where it most represents their subjective perception between both ends.
Time Frame
Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Title
Palatability - Sweet
Description
100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the positive response. Participants mark along the line where it most represents their subjective perception between both ends.
Time Frame
Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Title
Palatability - Savoury
Description
100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the positive response. Participants mark along the line where it most represents their subjective perception between both ends.
Time Frame
Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Title
Pre-meal and changes in glucose
Description
Blood samples will be collected by a trained phlebotomist via cannula.
Time Frame
4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Title
Pre-meal and changes in insulin
Description
Blood samples will be collected by a trained phlebotomist via cannula.
Time Frame
4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Title
Pre-meal and changes in growth hormone
Description
Blood samples will be collected by a trained phlebotomist via cannula.
Time Frame
4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Title
Pre-meal and changes in cortisol
Description
Blood samples will be collected by a trained phlebotomist via cannula.
Time Frame
4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Title
Pre-meal and changes in GLP-1
Description
Blood samples will be collected by a trained phlebotomist via cannula.
Time Frame
4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Title
Pre-meal and changes in PYY
Description
Blood samples will be collected by a trained phlebotomist via cannula.
Time Frame
4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Title
Pre-meal and changes in Total Ghrelin
Description
Blood samples will be collected by a trained phlebotomist via cannula.
Time Frame
4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Title
Pre-meal and changes in Acylated Ghrelin
Description
Blood samples will be collected by a trained phlebotomist via cannula.
Time Frame
4 hours, from fasting state (morning) to immediately prior to lunch meal (afternoon): fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement
Title
Pre-meal and changes in Hunger
Description
Validated 100 mm Visual Analogue Scales (VAS) will be used to estimate changes in appetite, assessed at fourteen (14) set time points throughout the experimental visit. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the extreme positive response. Participants mark along the line where it most represents their subjective perception between both ends. Composite Appetite Score derived from aspects such as hunger, fullness, desire to eat and prospective food consumption will be calculated. Fasting, mean and AUC values will be calculated.
Time Frame
8.5 hours: fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement and a standard meal; at 30, 60, 120 and 180 minutes following ingestion of supplement and test meal.
Title
Pre-meal and changes in Fullness
Description
Validated 100 mm Visual Analogue Scales (VAS) will be used to estimate changes in appetite, assessed at fourteen (14) set time points throughout the experimental visit. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the extreme positive response. Participants mark along the line where it most represents their subjective perception between both ends. Composite Appetite Score derived from aspects such as hunger, fullness, desire to eat and prospective food consumption will be calculated. Fasting, mean and AUC values will be calculated.
Time Frame
8.5 hours: fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement and a standard meal; at 30, 60, 120 and 180 minutes following ingestion of supplement and test meal.
Title
Pre-meal and changes in Desire to Eat
Description
Validated 100 mm Visual Analogue Scales (VAS) will be used to estimate changes in appetite, assessed at fourteen (14) set time points throughout the experimental visit. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the extreme positive response. Participants mark along the line where it most represents their subjective perception between both ends. Composite Appetite Score derived from aspects such as hunger, fullness, desire to eat and prospective food consumption will be calculated. Fasting, mean and AUC values will be calculated.
Time Frame
8.5 hours: fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement and a standard meal; at 30, 60, 120 and 180 minutes following ingestion of supplement and test meal.
Title
Pre-meal and changes in Prospective Food Consumption
Description
Validated 100 mm Visual Analogue Scales (VAS) will be used to estimate changes in appetite, assessed at fourteen (14) set time points throughout the experimental visit. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the extreme positive response. Participants mark along the line where it most represents their subjective perception between both ends. Composite Appetite Score derived from aspects such as hunger, fullness, desire to eat and prospective food consumption will be calculated. Fasting, mean and AUC values will be calculated.
Time Frame
8.5 hours: fasting, before breakfast, at 30, 60, 120, 180 and 210 minutes following ingestion of supplement and a standard meal; at 30, 60, 120 and 180 minutes following ingestion of supplement and test meal.
Title
Liking of test meals
Description
9-point likert scale from 0 dislike extremely to 9 like extremely
Time Frame
Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luccas de Faria, MSc
Phone
+39 351 990 3367
Email
luccas.faria@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Vigo, MSc
Phone
+39 345 920 0778
Email
lisa.vigo97@gmail.com
Facility Information:
Facility Name
University College Dublin
City
Dublin
State/Province
Leinster
ZIP/Postal Code
D04 V1W8
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luccas de Faria, MSc
Phone
+39 3519903367
Email
luccas.faria@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Effect of a Novel Protein Supplement on Appetite in Older Adults

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