NCT04869722

Brief Summary

This study aims to investigate whether consumers differ in mouthdrying sensitivity and if mouthdrying can be modulated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

May 27, 2021

Status Verified

May 1, 2021

Enrollment Period

24 days

First QC Date

April 27, 2021

Last Update Submit

May 26, 2021

Conditions

Keywords

Older adultsMouthdryingProtein fortified foods and beverages

Outcome Measures

Primary Outcomes (1)

  • Whey Protein Beverages Mouthdrying Just Noticeable Difference Threshold

    Perceived mouthdrying from whey protein beverages varying in protein levels using data from sensory methods (discrimination tests asking "which sample is more mouthdrying" in each pair)

    1 hour (sampled at visit one)

Secondary Outcomes (2)

  • Whey Protein Beverages Mouthdrying Ratings

    1 hour (sampled at visit one)

  • Modulating mouthdrying

    1 hour (sampled at visit one)

Study Arms (2)

Liquid Model

EXPERIMENTAL

Whey protein beverages varying in protein levels

Behavioral: Liquid Model

Solid Model

EXPERIMENTAL

Protein fortified scones varying in fat levels

Behavioral: Solid Model

Interventions

Liquid ModelBEHAVIORAL

Whey protein beverages will be used, with the amount of protein varied to study the effect on perception of the products (using sensory methods rating mouthdrying and discrimination tests 'which sample is more mouthdrying') all measured at home.

Liquid Model
Solid ModelBEHAVIORAL

Protein fortified scones will be used, with the amount of fat varied to study the effect on perception of the products (using sensory methods rating mouthdrying and discrimination tests 'which sample is more mouthdrying') all measured at home.

Solid Model

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age (18-30 years or over 65 years)
  • Healthy

You may not qualify if:

  • Relevant food allergies or intolerance
  • Outside age criteria
  • Diabetic
  • Had oral surgery
  • Had a stroke
  • Smoker
  • Cancer Taking prescribed medication that could influence study outcomes Anyone who currently has COVID-19 symptoms or who has had COVID-19 within the last 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sensory Science Centre, Department of Food and Nutritional Science, University of Reading, Reading, Berkshire, United Kingdom

Reading, RG66UR, United Kingdom

Location

Related Publications (4)

  • Norton V, Lignou S, Bull SP, Gosney MA, Methven L. An Investigation of the Influence of Age and Saliva Flow on the Oral Retention of Whey Protein and Its Potential Effect on the Perception and Acceptance of Whey Protein Beverages. Nutrients. 2020 Aug 19;12(9):2506. doi: 10.3390/nu12092506.

    PMID: 32825104BACKGROUND
  • Norton V, Lignou S, Bull SP, Gosney MA, Methven L. Consistent Effects of Whey Protein Fortification on Consumer Perception and Liking of Solid Food Matrices (Cakes and Biscuits) Regardless of Age and Saliva Flow. Foods. 2020 Sep 21;9(9):1328. doi: 10.3390/foods9091328.

    PMID: 32967299BACKGROUND
  • Bull SP, Hong Y, Khutoryanskiy VV, Parker JK, Faka M, Methven L. Whey protein mouth drying influenced by thermal denaturation. Food Qual Prefer. 2017 Mar;56(Pt B):233-240. doi: 10.1016/j.foodqual.2016.03.008.

    PMID: 28260840BACKGROUND
  • Withers CA, Lewis MJ, Gosney MA, Methven L. Potential sources of mouth drying in beverages fortified with dairy proteins: A comparison of casein- and whey-rich ingredients. J Dairy Sci. 2014 Mar;97(3):1233-47. doi: 10.3168/jds.2013-7273. Epub 2014 Jan 17.

    PMID: 24440265BACKGROUND

MeSH Terms

Conditions

Food IntoleranceFood Preferences

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Study Officials

  • Lisa Methven

    University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
All samples provided to the participant are labelled with 3 digit random codes
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: This study involves both a crossover design where each participant tastes different protein fortified products with an appropriate break between the tasting. It is also both a within and between groups design as the responses from the older volunteers will be compared with the younger volunteers. The study will be conducted single blind as it not feasible to blind the researcher. Each participant will attend 1 study visits and all products will be presented with random blinding codes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Food and Sensory Science

Study Record Dates

First Submitted

April 27, 2021

First Posted

May 3, 2021

Study Start

April 21, 2021

Primary Completion

May 15, 2021

Study Completion

May 15, 2021

Last Updated

May 27, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

No personal identification data will be shared. The study is not under an obligation to share data, however it is possible that some of the individual (unliked / non identifiable) data will be useful in a meta analysis and, hence sharing individual participant data (IPD) will be considered.

Locations