Effect of a Novel Protein Supplement on Appetite in Older Adults

Sponsor

University College Dublin (Other)

Overall Status

Recruiting

CT.gov ID

NCT05871060

Collaborator

FHI 360 (Other)

Enrollment

Location

Arms

7.2

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aging Appetite Loss	Dietary Supplement: Whey Protein Concentrate Dietary Supplement: Placebo Dietary Supplement: Whey hydrolysate	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Investigator)

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.

Primary Purpose:

Treatment

Official Title:

Effect of a Novel Protein Supplement on Appetite in Older Adults

Actual Study Start Date :

Apr 25, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: whey concentrate supplement 2,2 grams of whey concentrate dissolved in 100 mL of water	Dietary Supplement: Whey Protein Concentrate Whey protein concentrate consumed 30 minutes prior to breakfast and lunch meals
Experimental: whey hydrolysate supplement 2,2 grams of whey hydrolysate dissolved in 100 mL of water	Dietary Supplement: Whey hydrolysate Whey hydrolysate consumed 30 minutes prior to breakfast and lunch meals
Placebo Comparator: still flavoured water 100 mL of vanilla-flavoured water	Dietary Supplement: Placebo Flavoured water consumed 30 minutes prior to breakfast and lunch meals

Arm

Intervention/Treatment

Active Comparator: whey concentrate supplement

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

Dietary Supplement: Whey Protein Concentrate

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

Experimental: whey hydrolysate supplement

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

Dietary Supplement: Whey hydrolysate

Whey hydrolysate consumed 30 minutes prior to breakfast and lunch meals

Placebo Comparator: still flavoured water

100 mL of vanilla-flavoured water

Dietary Supplement: Placebo

Flavoured water consumed 30 minutes prior to breakfast and lunch meals

Outcome Measures

Primary Outcome Measures

Pre-meal and changes in Composite Appetite Score [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.]
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 hours from breakfast, lunch and dinner meals, as well as from evening and night from provided snackbox.]
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 [Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner]
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 [Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner]
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 [Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner]
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 [Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner]
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 [Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner]
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 [Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner]
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 [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]
Blood samples will be collected by a trained phlebotomist via cannula.
Pre-meal and changes in insulin [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]
Blood samples will be collected by a trained phlebotomist via cannula.
Pre-meal and changes in growth hormone [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]
Blood samples will be collected by a trained phlebotomist via cannula.
Pre-meal and changes in cortisol [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]
Blood samples will be collected by a trained phlebotomist via cannula.
Pre-meal and changes in GLP-1 [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]
Blood samples will be collected by a trained phlebotomist via cannula.
Pre-meal and changes in PYY [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]
Blood samples will be collected by a trained phlebotomist via cannula.
Pre-meal and changes in Total Ghrelin [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]
Blood samples will be collected by a trained phlebotomist via cannula.
Pre-meal and changes in Acylated Ghrelin [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]
Blood samples will be collected by a trained phlebotomist via cannula.
Pre-meal and changes in Hunger [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.]
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 [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.]
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 [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.]
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 [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.]
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 [Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner]
9-point likert scale from 0 dislike extremely to 9 like extremely

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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