Back to results

Investigating Consumers Perception and Acceptance of Whey Beverages

Primary Purpose

Individual Difference, Food Sensitivity, Food Preferences

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Liquid Model

About this trial

This is an interventional other trial for Individual Difference focused on measuring Mouthdrying, Saliva Flow, Mucoadhesion, Oral Nutritional Supplements

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy
No food allergies or intolerances
Non smokers

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Protein Beverage

Control Beverage

Arm Description

Whey Protein Beverage

Whey Permeate Beverage

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mouthdrying from whey beverages

Perceived mouth drying from whey beverages (whey permeate / whey protein) using data from sensory methods (rating drying as well as discrimination tests "which is the stronger in drying"). Scale for scoring is the gLMS scale (general linear magnitude scale); higher value is worse outcome.

Manipulating saliva flow and mouthdrying from whey beverages

Volunteers will be asked to manipulate their saliva flow and consume whey beverages (whey permeate / whey protein) and score perceived mouth drying (data will be collected from sensory methods (rating drying as well as discrimination tests "which is the stronger in drying")

Saliva collection

Salivary flow rates from unstimulated and stimulated saliva samples.

Full Information

NCT ID

NCT04507399

First Posted

July 25, 2020

Last Updated

March 11, 2021

Sponsor

University of Reading

1. Study Identification

Unique Protocol Identification Number

NCT04507399

Brief Title

Investigating Consumers Perception and Acceptance of Whey Beverages

Official Title

Investigating Consumers Perception and Acceptance of Whey Beverages

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

August 6, 2020 (Actual)

Primary Completion Date

September 10, 2020 (Actual)

Study Completion Date

September 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Reading

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

To investigate whether whey protein beverages causes mouthdrying and reduces acceptability compared with a control beverage (whey permeate beverage) and to determine whether manipulating salivary flow rates influences mouthdrying. To determine whether mucoadhesion is a probable cause of mouthdrying.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Individual Difference, Food Sensitivity, Food Preferences

Keywords

Mouthdrying, Saliva Flow, Mucoadhesion, Oral Nutritional Supplements

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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.

Masking

Participant

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Protein Beverage

Arm Type

Experimental

Arm Description

Whey Protein Beverage

Arm Title

Control Beverage

Arm Type

Experimental

Arm Description

Whey Permeate Beverage

Intervention Type

Behavioral

Intervention Name(s)

Liquid Model

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mucoadhesion and Mouthdrying

Description

Time Frame

Saliva collection and mouthdrying scoring throughout visits, 2 days

Secondary Outcome Measure Information:

Title

Mouthdrying from whey beverages

Description

Time Frame

1 day (Sampled at study visit one)

Title

Manipulating saliva flow and mouthdrying from whey beverages

Description

Time Frame

1 day (Sampled at study visit one)

Title

Saliva collection

Description

Salivary flow rates from unstimulated and stimulated saliva samples.

Time Frame

1 day (Sampled at study visit two)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy No food allergies or intolerances Non smokers Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lisa Methven

Organizational Affiliation

University of Reading

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Reading

ZIP/Postal Code

RG66UR

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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.

Citations:

PubMed Identifier

28260840

Citation

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.

Results Reference

background

PubMed Identifier

24092277

Citation

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.

Results Reference

background

PubMed Identifier

26456531

Citation

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.

Results Reference

background

PubMed Identifier

24440265

Citation

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.

Results Reference

background

Learn more about this trial

Investigating Consumers Perception and Acceptance of Whey Beverages

We'll reach out to this number within 24 hrs