Effect of a Novel Protein Supplement on Appetite in Older Adults

Study Overview
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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.

Official Title
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Effect of a Novel Protein Supplement on Appetite in Older Adults

Conditions
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Aging, Appetite Loss

Intervention / Treatment
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* Dietary Supplement: Whey Protein Concentrate
* Dietary Supplement: Placebo
* Dietary Supplement: Whey hydrolysate


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All participants undertake all three experimental conditions in a random order.
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Appetite, Poor Appetite, Ageing, Whey protein hydrolysate, Visual analogue scale, Energy intake, Ghrelin