Reduced appetite can occur with ageing and is linked to a higher risk of undernutrition, poorer physical function and becoming frail. Strategies to increase appetite are needed to improve healthy ageing. This study follows on from previous work which has found a novel ingredient in whey protein (derived from whole milk) that may help to increase appetite and energy intake. This study will compare the effects of the ingredient added to an oral nutritional supplement (ONS) versus the ONS alone versus the ingredient dissolved in water on appetite in older adults. By studying this nutrition supplement in older adults, this will help to provide greater information on possible nutrition strategies to improve healthy ageing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
17
Commercially available Oral Nutritional Supplement alone consumed 90 minutes prior to an ad libitum breakfast
Whey Protein Hydrolysate dissolved in an Oral Nutritional Supplement consumed 90 minutes prior to an ad libitum breakfast
Whey Protein Hydrolysate dissolved in still water consumed 90 minutes prior to an ad libitum breakfast
University College Dublin
Dublin, Leinster, Ireland
Pre-meal and changes in Hunger
Validated 100-millimetre Visual Analogue Scales (VAS) will be used to assess hunger, at ten (10) 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. Hunger is directly obtained from its VAS rating. Changes between fast and post-meal, mean and AUC values will be calculated.
Time frame: 9.5 hours: fast (pre-ONS), pre-breakfast: 90 (post-ONS), 60, 30 and 0 min; post-breakfast: 0 and 180 min (pre-lunch); post-lunch: 0 and 90 min (pre-ONS); 0 min post-ONS; estimated 120 min. post-ONS (pre-dinner); 0 min. post-dinner
Energy Intake (EI) from an ad libitum breakfast meal (kilocalories)
First meal (ad libitum breakfast) energy intake measurement. Participants will be served a standardised ad libitum breakfast in the laboratory. EI (kilocalories) will be measured objectively, by weighing foods before and after consumption and calculating energy intake based on their nutritional data.
Time frame: Measures taken immediately following the ad libitum test meal (a single measurement)
Palatability - Pleasantness
Validated 100-millimetre Visual Analogue Scales (VAS) will be used after each test meal: test supplement, breakfast, lunch, test supplement and dinner. 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.
Time frame: 9.5 hours: mean of ratings taken immediately following the three test meals and the two intakes of the test supplement (single measure), i.e., supplement, breakfast, lunch, supplement, dinner
Palatability - Filling
Validated 100-millimetre Visual Analogue Scales (VAS) will be used after each test meal: test supplement, breakfast, lunch, test supplement and dinner. 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.
Time frame: 9.5 hours: mean of ratings taken immediately following the three test meals and the two intakes of the test supplement (single measure), i.e., supplement, breakfast, lunch, supplement, dinner
Palatability - Satisfaction
Validated 100-millimetre Visual Analogue Scales (VAS) will be used after each test meal: test supplement, breakfast, lunch, test supplement and dinner. 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.
Time frame: 9.5 hours: mean of ratings taken immediately following the three test meals and the two intakes of the test supplement (single measure), i.e., supplement, breakfast, lunch, supplement, dinner
Palatability - Taste
Validated 100-millimetre Visual Analogue Scales (VAS) will be used after each test meal: test supplement, breakfast, lunch, test supplement and dinner. 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.
Time frame: 9.5 hours: mean of ratings taken immediately following the three test meals and the two intakes of the test supplement (single measure), i.e., supplement, breakfast, lunch, supplement, dinner
Palatability - Sweet
Validated 100-millimetre Visual Analogue Scales (VAS) will be used after each test meal: test supplement, breakfast, lunch, test supplement and dinner. 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.
Time frame: 9.5 hours: mean of ratings taken immediately following the three test meals and the two intakes of the test supplement (single measure), i.e., supplement, breakfast, lunch, supplement, dinner
Palatability - Savoury
Validated 100-millimetre Visual Analogue Scales (VAS) will be used after each test meal: test supplement, breakfast, lunch, test supplement and dinner. 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.
Time frame: 9.5 hours: mean of ratings taken immediately following the three test meals and the two intakes of the test supplement (single measure), i.e., supplement, breakfast, lunch, supplement, dinner
Pre-meal and changes in Composite Appetite Score
Validated 100-millimetre Visual Analogue Scales (VAS) will be used to estimate changes in appetite, assessed at ten (10) 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. Fasting, mean and AUC values will be calculated.
Time frame: 9.5 hours: fast (pre-ONS), pre-breakfast: 90 (post-ONS), 60, 30 and 0 min; post-breakfast: 0 and 180 min (pre-lunch); post-lunch: 0 and 90 min (pre-ONS); 0 min post-ONS; estimated 120 min. post-ONS (pre-dinner); 0 min. post-dinner
Pre-meal and changes in Fullness
Validated 100-millimetre Visual Analogue Scales (VAS) will be used to estimate changes in appetite, assessed at ten (10) 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. Fasting, mean and AUC values will be calculated.
Time frame: 9.5 hours: fast (pre-ONS), pre-breakfast: 90 (post-ONS), 60, 30 and 0 min; post-breakfast: 0 and 180 min (pre-lunch); post-lunch: 0 and 90 min (pre-ONS); 0 min post-ONS; estimated 120 min. post-ONS (pre-dinner); 0 min. post-dinner
Pre-meal and changes in Desire to Eat
Validated 100-millimetre Visual Analogue Scales (VAS) will be used to estimate changes in appetite, assessed at ten (10) 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. Fasting, mean and AUC values will be calculated.
Time frame: 9.5 hours: fast (pre-ONS), pre-breakfast: 90 (post-ONS), 60, 30 and 0 min; post-breakfast: 0 and 180 min (pre-lunch); post-lunch: 0 and 90 min (pre-ONS); 0 min post-ONS; estimated 120 min. post-ONS (pre-dinner); 0 min. post-dinner
Pre-meal and changes in Prospective Food Consumption
Validated 100-millimetre Visual Analogue Scales (VAS) will be used to estimate changes in appetite, assessed at ten (10) 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. Fasting, mean and AUC values will be calculated.
Time frame: 9.5 hours: fast (pre-ONS), pre-breakfast: 90 (post-ONS), 60, 30 and 0 min; post-breakfast: 0 and 180 min (pre-lunch); post-lunch: 0 and 90 min (pre-ONS); 0 min post-ONS; estimated 120 min. post-ONS (pre-dinner); 0 min. post-dinner
Liking of test meals and supplements
9-point likert scale from 0 dislike extremely to 9 like extremely
Time frame: Mean of ratings taken immediately following the three test meals and the two intakes of the test supplement (single measure), i.e., supplement, breakfast, lunch, supplement, dinner
Pre-meal and changes in Glucose
Blood samples will be collected by a trained phlebotomist via cannula.
Time frame: Up to 2 hours, from fast (morning) to immediately prior to breakfast meal: fasting (immediately before test supplement), and 30, 60, 90 minutes following ingestion of the test supplement
Pre-meal and changes in Insulin
Blood samples will be collected by a trained phlebotomist via cannula.
Time frame: Up to 2 hours, from fast (morning) to immediately prior to breakfast meal: fasting (immediately before test supplement), and 30, 60, 90 minutes following ingestion of the test supplement
Pre-meal and changes in Growth Hormone
Blood samples will be collected by a trained phlebotomist via cannula.
Time frame: Up to 2 hours, from fast (morning) to immediately prior to breakfast meal: fasting (immediately before test supplement), and 30, 60, 90 minutes following ingestion of the test supplement
Pre-meal and changes in Cortisol
Blood samples will be collected by a trained phlebotomist via cannula.
Time frame: Up to 2 hours, from fast (morning) to immediately prior to breakfast meal: fasting (immediately before test supplement), and 30, 60, 90 minutes following ingestion of the test supplement
Pre-meal and changes in GLP-1
Blood samples will be collected by a trained phlebotomist via cannula.
Time frame: Up to 2 hours, from fast (morning) to immediately prior to breakfast meal: fasting (immediately before test supplement), and 30, 60, 90 minutes following ingestion of the test supplement
Pre-meal and changes in PYY
Blood samples will be collected by a trained phlebotomist via cannula.
Time frame: Up to 2 hours, from fast (morning) to immediately prior to breakfast meal: fasting (immediately before test supplement), and 30, 60, 90 minutes following ingestion of the test supplement
Pre-meal and changes in Total Ghrelin
Blood samples will be collected by a trained phlebotomist via cannula.
Time frame: Up to 2 hours, from fast (morning) to immediately prior to breakfast meal: fasting (immediately before test supplement), and 30, 60, 90 minutes following ingestion of the test supplement
Pre-meal and changes in Acylated Ghrelin
Blood samples will be collected by a trained phlebotomist via cannula.
Time frame: Up to 2 hours, from fast (morning) to immediately prior to breakfast meal: fasting (immediately before test supplement), and 30, 60, 90 minutes following ingestion of the test supplement
Total Energy intake (EI) (kilocalories)
24-hour energy intake measurement derived from in-lab day trial plus free-living intake of standard meals plus food diary completed at home. Participants will be served a test supplement in two different time points, a standardised ad libitum breakfast, two standardised main meals (lunch and dinner) and will be required to complete a food diary from the dinner until bedtime. 24-hour EI (kilocalories) will be measured objectively, by weighing foods before and after consumption and calculating energy intake based on their nutritional data, and estimating caloric content from food diary provided. Total accumulated energy intake includes ad libitum breakfast meal, two test supplements, lunch meal, dinner meal and evening foods.
Time frame: 24 hours from breakfast, lunch and dinner meals, as well as from evening and night
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