NCT04507399

Brief Summary

Brief Summary: This study aims to investigate whether protein fortification of beverages causes mouthdrying and mucoadhesion and whether this is influenced by saliva flow.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

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

July 25, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

August 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2020

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

1 month

First QC Date

July 25, 2020

Last Update Submit

March 11, 2021

Conditions

Keywords

MouthdryingSaliva FlowMucoadhesionOral Nutritional Supplements

Outcome Measures

Primary Outcomes (1)

  • Mucoadhesion and Mouthdrying

    Following swallowing of different whey beverage samples (whey protein / whey permeate), volunteers will be asked either to rate samples for mouthdrying or to spit their saliva into a tube at specific timepoints (15s \& 60s) with appropriate rest periods. The rating and spitting times will be set within a balanced order protocol.

    Saliva collection and mouthdrying scoring throughout visits, 2 days

Secondary Outcomes (3)

  • Mouthdrying from whey beverages

    1 day (Sampled at study visit one)

  • Manipulating saliva flow and mouthdrying from whey beverages

    1 day (Sampled at study visit one)

  • Saliva collection

    1 day (Sampled at study visit two)

Study Arms (2)

Protein Beverage

EXPERIMENTAL

Whey Protein Beverage

Behavioral: Liquid Model

Control Beverage

EXPERIMENTAL

Whey Permeate Beverage

Behavioral: Liquid Model

Interventions

Liquid ModelBEHAVIORAL

To study the perception of whey beverages using sensory methods (rating drying as well as discrimination tests "which is the stronger in drying") Measuring mucoadhesion via protein content remaining in saliva following swallowing of whey protein and whey permeate beverages.

Control BeverageProtein Beverage

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • No food allergies or intolerances
  • Non smokers

You may not qualify if:

  • Taking prescribed medication that could influence study outcomes (such as saliva flow)
  • Relevant food allergies or intolerances
  • Outside age criteria
  • Cancer
  • Had oral surgery or a stroke
  • Smoker
  • Diabetic
  • 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)

  • 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, Cook MT, Methven L, Gosney MA, Khutoryanskiy VV. Investigation of milk proteins binding to the oral mucosa. Food Funct. 2013 Nov;4(11):1668-74. doi: 10.1039/c3fo60291e.

    PMID: 24092277BACKGROUND
  • Affoo RH, Foley N, Garrick R, Siqueira WL, Martin RE. Meta-Analysis of Salivary Flow Rates in Young and Older Adults. J Am Geriatr Soc. 2015 Oct;63(10):2142-51. doi: 10.1111/jgs.13652. Epub 2015 Oct 12.

    PMID: 26456531BACKGROUND
  • 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
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: This study involves both a crossover design where each participant tastes both the control product and the protein fortified product with an appropriate break between the two sessions. The study will be conducted single blind as it not feasible to blind the researcher. Each participant will attend 2 study visits and all foods will be presented with random blinding codes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Sensory Science

Study Record Dates

First Submitted

July 25, 2020

First Posted

August 11, 2020

Study Start

August 6, 2020

Primary Completion

September 10, 2020

Study Completion

September 10, 2020

Last Updated

March 12, 2021

Record last verified: 2021-03

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