Effect of a Novel Protein Supplement on Appetite in Older Adults

Aging Clinical Trial

Official title:

Effect of a Novel Protein Supplement on Appetite in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05871060
• Other study ID #: LS-22-64-Horner
• Secondary ID: TC201800025
• Status: Completed
• Phase: N/A
• Start date: April 25, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: November 2023
• Source: University College Dublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 30, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Anorexia
• Appetite Loss

Intervention

Dietary Supplement:
• Whey Protein Concentrate
Whey protein concentrate consumed 30 minutes prior to breakfast and lunch meals
• Placebo
Flavoured water consumed 30 minutes prior to breakfast and lunch meals
• Whey hydrolysate
Whey hydrolysate consumed 30 minutes prior to breakfast and lunch meals

Locations

Country	Name	City	State
Ireland	University College Dublin	Dublin	Leinster

Sponsors (2)

Lead Sponsor	Collaborator
University College Dublin	FHI 360

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Primary	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.	24 hours from breakfast, lunch and dinner meals, as well as from evening and night from provided snackbox.
Secondary	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.	Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Secondary	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.	Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Secondary	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.	Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Secondary	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.	Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Secondary	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.	Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Secondary	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.	Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Secondary	Pre-meal and changes in glucose	Blood samples will be collected by a trained phlebotomist via cannula.	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
Secondary	Pre-meal and changes in insulin	Blood samples will be collected by a trained phlebotomist via cannula.	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
Secondary	Pre-meal and changes in growth hormone	Blood samples will be collected by a trained phlebotomist via cannula.	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
Secondary	Pre-meal and changes in cortisol	Blood samples will be collected by a trained phlebotomist via cannula.	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
Secondary	Pre-meal and changes in GLP-1	Blood samples will be collected by a trained phlebotomist via cannula.	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
Secondary	Pre-meal and changes in PYY	Blood samples will be collected by a trained phlebotomist via cannula.	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
Secondary	Pre-meal and changes in Total Ghrelin	Blood samples will be collected by a trained phlebotomist via cannula.	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
Secondary	Pre-meal and changes in Acylated Ghrelin	Blood samples will be collected by a trained phlebotomist via cannula.	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
Secondary	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.	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.
Secondary	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.	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.
Secondary	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.	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.
Secondary	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.	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.
Secondary	Liking of test meals	9-point likert scale from 0 dislike extremely to 9 like extremely	Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner