Clinical trial NCT06478147: Effect of a Novel Protein Ingredient Combined With Oral Nutritional Supplement on Appetite in Older Adults
Official title: Effect of a Novel Protein Ingredient Combined With Oral Nutritional Supplement on Appetite in Older Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aging
Appetite Loss
Undernutrition
Keywords: Appetite
Poor Appetite
Ageing
Whey protein hydrolysate
Visual analogue scale
Energy intake
Ghrelin
Oral Nutritional Supplement
Dairy
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: FHI 360
First posted: 2024-06-27
Enrollment: 17
Sex: ALL
Minimum age (years): 60
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment

All participants undertake all three experimental conditions in a random order.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pre-meal and changes in Hunger
timeFrame: 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
measure: Energy Intake (EI) from an ad libitum breakfast meal (kilocalories)
timeFrame: Measures taken immediately following the ad libitum test meal (a single measurement)
Secondary outcomes:
measure: Palatability - Pleasantness
timeFrame: 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
measure: Palatability - Filling
timeFrame: 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
measure: Palatability - Satisfaction
timeFrame: 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
measure: Palatability - Taste
timeFrame: 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
measure: Palatability - Sweet
timeFrame: 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
measure: Palatability - Savoury
timeFrame: 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
measure: Pre-meal and changes in Composite Appetite Score
timeFrame: 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
measure: Pre-meal and changes in Fullness
timeFrame: 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
measure: Pre-meal and changes in Desire to Eat
timeFrame: 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
measure: Pre-meal and changes in Prospective Food Consumption
timeFrame: 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
measure: Liking of test meals and supplements
timeFrame: 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
measure: Pre-meal and changes in Glucose
timeFrame: 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
measure: Pre-meal and changes in Insulin
timeFrame: 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
measure: Pre-meal and changes in Growth Hormone
timeFrame: 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
measure: Pre-meal and changes in Cortisol
timeFrame: 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
measure: Pre-meal and changes in GLP-1
timeFrame: 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
measure: Pre-meal and changes in PYY
timeFrame: 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
measure: Pre-meal and changes in Total Ghrelin
timeFrame: 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
measure: Pre-meal and changes in Acylated Ghrelin
timeFrame: 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
measure: Total Energy intake (EI) (kilocalories)
timeFrame: 24 hours from breakfast, lunch and dinner meals, as well as from evening and night
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: University College Dublin
state: Leinster
Study officials:
References: