Effect of a Novel Protein Ingredient Combined With Oral Nutritional Supplement on Appetite in Older Adults
- Conditions
- UndernutritionAgingAppetite Loss
- Interventions
- Dietary Supplement: Oral Nutritional Supplement + Whey Protein HydrolysateDietary Supplement: Whey Protein Hydrolysate + still waterDietary Supplement: Oral Nutritional Supplement
- Registration Number
- NCT06478147
- Lead Sponsor
- University College Dublin
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 17
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Oral Nutritional Supplement + Whey Protein Hydrolysate Oral Nutritional Supplement + Whey Protein Hydrolysate 2,2 grams of whey protein hydrolysate dissolved in 125 mL of commercially available of Oral Nutritional Supplement Whey Protein Hydrolysate Whey Protein Hydrolysate + still water 2,2 grams of whey protein hydrolysate dissolved in 125 mL of water Oral Nutritional Supplement Oral Nutritional Supplement 125 mL of commercially available of Oral Nutritional Supplement, a liquid food product containing vitamins, minerals, protein, fats and carbohydrates. 125 mL of product provides 37.0 g of carbohydrates, 11.6 g of fats, 12.0 g of proteins, vitamins and minerals.
- Primary Outcome Measures
Name Time Method Energy Intake (EI) from an ad libitum breakfast meal (kilocalories) Measures taken immediately following the ad libitum test meal (a single measurement) 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.
Pre-meal and changes in Hunger 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 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.
- Secondary Outcome Measures
Name Time Method Palatability - Taste 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 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.
Palatability - Filling 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 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.
Pre-meal and changes in Growth Hormone 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 Blood samples will be collected by a trained phlebotomist via cannula.
Pre-meal and changes in Acylated Ghrelin 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 Blood samples will be collected by a trained phlebotomist via cannula.
Palatability - Pleasantness 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 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.
Palatability - Sweet 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 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.
Pre-meal and changes in GLP-1 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 Blood samples will be collected by a trained phlebotomist via cannula.
Pre-meal and changes in PYY 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 Blood samples will be collected by a trained phlebotomist via cannula.
Palatability - Satisfaction 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 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.
Palatability - Savoury 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 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.
Pre-meal and changes in Glucose 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 Blood samples will be collected by a trained phlebotomist via cannula.
Pre-meal and changes in Composite Appetite Score 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 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.
Pre-meal and changes in Fullness 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 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.
Pre-meal and changes in Desire to Eat 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 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.
Pre-meal and changes in Prospective Food Consumption 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 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.
Liking of test meals and supplements 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 9-point likert scale from 0 dislike extremely to 9 like extremely
Pre-meal and changes in Insulin 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 Blood samples will be collected by a trained phlebotomist via cannula.
Pre-meal and changes in Cortisol 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 Blood samples will be collected by a trained phlebotomist via cannula.
Total Energy intake (EI) (kilocalories) 24 hours from breakfast, lunch and dinner meals, as well as from evening and night 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.
Pre-meal and changes in Total Ghrelin 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 Blood samples will be collected by a trained phlebotomist via cannula.
Trial Locations
- Locations (1)
University College Dublin
🇮🇪Dublin, Leinster, Ireland