NCT05871060

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2023

Completed
25 days until next milestone

Study Start

First participant enrolled

April 25, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

5 months

First QC Date

March 31, 2023

Last Update Submit

November 23, 2023

Conditions

AgingAppetite Loss

Keywords

AppetitePoor AppetiteAgeingWhey protein hydrolysateVisual analogue scaleEnergy intakeGhrelin

Outcome Measures

Primary Outcomes (2)

  • Pre-meal and changes in Composite Appetite Score

    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.

    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.

  • Energy intake (EI) (kilocalories)

    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.

    24 hours from breakfast, lunch and dinner meals, as well as from evening and night from provided snackbox.

Secondary Outcomes (19)

  • 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

  • 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

  • Palatability - Sweet

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

  • +14 more secondary outcomes

Study Arms (3)

whey concentrate supplement

ACTIVE COMPARATOR

2,2 grams of whey concentrate dissolved in 100 mL of water

Dietary Supplement: Whey Protein Concentrate

whey hydrolysate supplement

EXPERIMENTAL

2,2 grams of whey hydrolysate dissolved in 100 mL of water

Dietary Supplement: Whey hydrolysate

still flavoured water

PLACEBO COMPARATOR

100 mL of vanilla-flavoured water

Dietary Supplement: Placebo

Interventions

Whey Protein ConcentrateDIETARY_SUPPLEMENT

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

whey concentrate supplement
PlaceboDIETARY_SUPPLEMENT

Flavoured water consumed 30 minutes prior to breakfast and lunch meals

still flavoured water
Whey hydrolysateDIETARY_SUPPLEMENT

Whey hydrolysate consumed 30 minutes prior to breakfast and lunch meals

whey hydrolysate supplement

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College Dublin

Dublin, Leinster, D04 V1W8, Ireland

Location

MeSH Terms

Conditions

Anorexia

Interventions

Whey

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: All participants undertake all three experimental conditions in a random order.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Sport and Exercise Science

Study Record Dates

First Submitted

March 31, 2023

First Posted

May 23, 2023

Study Start

April 25, 2023

Primary Completion

September 15, 2023

Study Completion

October 30, 2023

Last Updated

November 27, 2023

Record last verified: 2023-11

Locations

IE(1)