Clinical trial NCT05871060: Effect of a Novel Protein Supplement on Appetite in Older Adults
Official title: Effect of a Novel Protein Supplement on Appetite in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Appetite Loss
Keywords: Appetite
Poor Appetite
Ageing
Whey protein hydrolysate
Visual analogue scale
Energy intake
Ghrelin
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: FHI 360
First posted: 2023-05-23
Enrollment: 14
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants undertake all three experimental conditions in a random order.
Primary purpose: TREATMENT

Brief summary: 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.


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:

1. Current medical condition or medication known to impact appetite or energy intake
2. Other medical condition that would impact study participation and outcomes, as judged by the study investigator.
3. Heavy smoker (\>10/day)
4. Inability to come to study centre
5. Currently participating in another intervention study
6. Lacking informed consent
7. Allergic to or unwilling to consume any of the study test foods
8. Loss of taste or smell associated with COVID-19
9. Unable to walk across a room

Primary outcomes:
measure: Pre-meal and changes in Composite Appetite Score
timeFrame: 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.
measure: Energy intake (EI) (kilocalories)
timeFrame: 24 hours from breakfast, lunch and dinner meals, as well as from evening and night from provided snackbox.
Secondary outcomes:
measure: Palatability - Pleasantness
timeFrame: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
measure: Palatability - Filling
timeFrame: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
measure: Palatability - Satisfaction
timeFrame: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
measure: Palatability - Taste
timeFrame: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
measure: Palatability - Sweet
timeFrame: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
measure: Palatability - Savoury
timeFrame: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
measure: Pre-meal and changes in glucose
timeFrame: 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
measure: Pre-meal and changes in insulin
timeFrame: 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
measure: Pre-meal and changes in growth hormone
timeFrame: 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
measure: Pre-meal and changes in cortisol
timeFrame: 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
measure: Pre-meal and changes in GLP-1
timeFrame: 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
measure: Pre-meal and changes in PYY
timeFrame: 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
measure: Pre-meal and changes in Total Ghrelin
timeFrame: 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
measure: Pre-meal and changes in Acylated Ghrelin
timeFrame: 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
measure: Pre-meal and changes in Hunger
timeFrame: 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.
measure: Pre-meal and changes in Fullness
timeFrame: 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.
measure: Pre-meal and changes in Desire to Eat
timeFrame: 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.
measure: Pre-meal and changes in Prospective Food Consumption
timeFrame: 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.
measure: Liking of test meals
timeFrame: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: University College Dublin
state: Leinster
Study officials:
References: