Skip to main content
OpenTrials
Completed

NCT Number: NCT05871060

Effect of a Novel Protein Supplement on Appetite in Older Adults

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aging Anorexia Appetite Loss Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College Dublin

Dublin, Leinster, D04 V1W8, Ireland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whey Protein Concentrate

Dietary Supplement

Whey protein concentrate consumed 30 minutes prior to breakfast and lunch meals

Placebo

Dietary Supplement

Flavoured water consumed 30 minutes prior to breakfast and lunch meals

Whey hydrolysate

Dietary Supplement

Whey hydrolysate consumed 30 minutes prior to breakfast and lunch meals

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Palatability - Pleasantness

    Time frame: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner

    100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response 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.

  2. Palatability - Filling

    Time frame: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner

    100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response 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.

  3. Palatability - Satisfaction

    Time frame: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner

    100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response 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.

  4. Palatability - Taste

    Time frame: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner

    100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response 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.

  5. Palatability - Sweet

    Time frame: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner

    100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response 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.

  6. Palatability - Savoury

    Time frame: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner

    100 millimetre Visual Analogue Scales (VAS) will be used after each test meal: breakfast, lunch and dinner. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the extreme negative response 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.

  7. Pre-meal and changes in glucose

    Time frame: 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

    Blood samples will be collected by a trained phlebotomist via cannula.

  8. Pre-meal and changes in insulin

    Time frame: 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

    Blood samples will be collected by a trained phlebotomist via cannula.

  9. Pre-meal and changes in growth hormone

    Time frame: 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

    Blood samples will be collected by a trained phlebotomist via cannula.

  10. Pre-meal and changes in cortisol

    Time frame: 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

    Blood samples will be collected by a trained phlebotomist via cannula.

  11. Pre-meal and changes in GLP-1

    Time frame: 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

    Blood samples will be collected by a trained phlebotomist via cannula.

  12. Pre-meal and changes in PYY

    Time frame: 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

    Blood samples will be collected by a trained phlebotomist via cannula.

  13. Pre-meal and changes in Total Ghrelin

    Time frame: 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

    Blood samples will be collected by a trained phlebotomist via cannula.

  14. Pre-meal and changes in Acylated Ghrelin

    Time frame: 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

    Blood samples will be collected by a trained phlebotomist via cannula.

  15. Pre-meal and changes in Hunger

    Time frame: 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.

    Validated 100 mm Visual Analogue Scales (VAS) will be used to estimate changes in appetite, assessed 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 (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the extreme positive response. Participants mark along the line where it most represents their subjective perception between both ends. Composite Appetite Score derived from aspects such as hunger, fullness, desire to eat and prospective food consumption will be calculated. Fasting, mean and AUC values will be calculated.

  16. Pre-meal and changes in Fullness

    Time frame: 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.

    Validated 100 mm Visual Analogue Scales (VAS) will be used to estimate changes in appetite, assessed 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 (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the extreme positive response. Participants mark along the line where it most represents their subjective perception between both ends. Composite Appetite Score derived from aspects such as hunger, fullness, desire to eat and prospective food consumption will be calculated. Fasting, mean and AUC values will be calculated.

  17. Pre-meal and changes in Desire to Eat

    Time frame: 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.

    Validated 100 mm Visual Analogue Scales (VAS) will be used to estimate changes in appetite, assessed 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 (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the extreme positive response. Participants mark along the line where it most represents their subjective perception between both ends. Composite Appetite Score derived from aspects such as hunger, fullness, desire to eat and prospective food consumption will be calculated. Fasting, mean and AUC values will be calculated.

  18. Pre-meal and changes in Prospective Food Consumption

    Time frame: 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.

    Validated 100 mm Visual Analogue Scales (VAS) will be used to estimate changes in appetite, assessed 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 (0 mm), the extreme negative response is represented, while the right end (100 mm) represents the extreme positive response. Participants mark along the line where it most represents their subjective perception between both ends. Composite Appetite Score derived from aspects such as hunger, fullness, desire to eat and prospective food consumption will be calculated. Fasting, mean and AUC values will be calculated.

  19. Liking of test meals

    Time frame: Mean of ratings taken immediately following the three test meals (single measure) - breakfast, lunch and dinner

    9-point likert scale from 0 dislike extremely to 9 like extremely

Sponsors and collaborators

Lead sponsor

University College Dublin

Other

Collaborators

  • FHI 360

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 23, 2023
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.