Effect of a Novel Protein Ingredient Combined With Oral Nutritional Supplement on Appetite in Older Adults
NCT Number: NCT06478147
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aging|Appetite Loss|Undernutrition
Interventions: DIETARY_SUPPLEMENT: Oral Nutritional Supplement|DIETARY_SUPPLEMENT: Oral Nutritional Supplement + Whey Protein Hydrolysate|DIETARY_SUPPLEMENT: Whey Protein Hydrolysate + still water
Sponsor: University College Dublin
Collaborators: FHI 360
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 17
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-12-02
Completion Date: 2024-06-29
Locations: University College Dublin, Dublin, Leinster, D04 V1W8, Ireland

Summary:
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.

Primary Outcome Measures: 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., 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., Measures taken immediately following the ad libitum test meal (a single measurement)
Secondary Outcome Measures: 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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, 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., 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., 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., 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., 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., 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., 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., 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., 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., 24 hours from breakfast, lunch and dinner meals, as well as from evening and night