Effect of a Novel Protein Supplement on Appetite in Older Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University College Dublin
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Energy intake (EI) (kilocalories)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Out of three treatments, the investigator is blinded for two of them (pre-labelled as A and B).
The participant is fully blinded, i.e. treatments will be served in black cups and vanilla-flavoured.
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
whey hydrolysate supplement
2,2 grams of whey hydrolysate dissolved in 100 mL of water
Intervention: Whey hydrolysate (Dietary Supplement)
still flavoured water
100 mL of vanilla-flavoured water
Intervention: Placebo (Dietary Supplement)
whey concentrate supplement
2,2 grams of whey concentrate dissolved in 100 mL of water
Intervention: Whey Protein Concentrate (Dietary Supplement)
Outcomes
Primary Outcomes
Energy intake (EI) (kilocalories)
Time Frame: 24 hours from breakfast, lunch and dinner meals, as well as from evening and night from provided snackbox.
24-hour energy intake measurement. Participants will be served a standardised fixed breakfast and ad libitum lunch and dinner meals in the laboratory and provided with an evening snack box. 24 hour EI (kilocalories) will be measured objectively, by weighing foods before and after consumption and calculating energy intake based on their nutritional data. Total accumulated energy intake includes standard breakfast meal, ad libitum lunch meal, ad libitum dinner meal and bag with known foods for the evening time.
Pre-meal and changes in Composite Appetite Score
Time Frame: 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.
Validated 100 millimetre Visual Analogue Scales (VAS) will be used to assess appetite, at fourteen (14) 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.
Secondary Outcomes
- Pre-meal and changes in Total Ghrelin(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)
- Pre-meal and changes in Acylated Ghrelin(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)
- Palatability - Savoury(Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner)
- Pre-meal and changes in growth hormone(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)
- Pre-meal and changes in cortisol(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)
- Pre-meal and changes in GLP-1(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)
- Pre-meal and changes in PYY(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)
- Pre-meal and changes in Prospective Food Consumption(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.)
- Palatability - Pleasantness(Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner)
- Palatability - Filling(Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner)
- Pre-meal and changes in Hunger(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.)
- Liking of test meals(Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner)
- Palatability - Sweet(Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner)
- Palatability - Satisfaction(Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner)
- Palatability - Taste(Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner)
- Pre-meal and changes in glucose(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)
- Pre-meal and changes in insulin(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)
- Pre-meal and changes in Fullness(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.)
- Pre-meal and changes in Desire to Eat(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.)
Investigators
Katy Horner
Lecturer in Sport and Exercise Science
University College Dublin