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Modifying Whey Protein Fortified Drinks and Foods

Primary Purpose

Individual Difference, Food Sensitivity, Food Preferences

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Liquid Model

Solid Model

About this trial

This is an interventional other trial for Individual Difference focused on measuring Older adults, Mouthdrying, Protein fortified foods and beverages

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

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

Liquid Model

Solid Model

Arm Description

Whey protein beverages varying in protein levels

Protein fortified scones varying in fat levels

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Whey Protein Beverages Mouthdrying Ratings

Perceived mouthdrying from whey protein beverages varying in protein levels using data from sensory methods (rating mouthdrying)

Modulating mouthdrying

Perceived mouthdrying from protein fortified scones varying in fat levels using data from sensory methods (rating mouthdrying as well as discrimination tests "which sample is more mouthdrying")

Full Information

NCT ID

NCT04869722

First Posted

April 27, 2021

Last Updated

May 26, 2021

Sponsor

University of Reading

Collaborators

Volac International Limited

1. Study Identification

Unique Protocol Identification Number

NCT04869722

Brief Title

Modifying Whey Protein Fortified Drinks and Foods

Official Title

Modifying Whey Protein Fortified Drinks and Foods to Improve Perception, Whilst Accounting for Individual Differences in Age (At Home Study)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

April 21, 2021 (Actual)

Primary Completion Date

May 15, 2021 (Actual)

Study Completion Date

May 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Reading

Collaborators

Volac International Limited

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

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

Detailed Description

To investigate whether older adults are more sensitive to whey protein derived mouthdrying compared with younger adults To investigate whether increasing fat levels in a solid whey protein model influences mouthdrying perception

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

Older adults, Mouthdrying, Protein fortified foods and beverages

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 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.

Masking

Participant

Masking Description

All samples provided to the participant are labelled with 3 digit random codes

Allocation

Randomized

Enrollment

116 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Liquid Model

Arm Type

Experimental

Arm Description

Whey protein beverages varying in protein levels

Arm Title

Solid Model

Arm Type

Experimental

Arm Description

Protein fortified scones varying in fat levels

Intervention Type

Behavioral

Intervention Name(s)

Liquid Model

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Solid Model

Intervention Description

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.

Primary Outcome Measure Information:

Title

Whey Protein Beverages Mouthdrying Just Noticeable Difference Threshold

Description

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)

Time Frame

1 hour (sampled at visit one)

Secondary Outcome Measure Information:

Title

Whey Protein Beverages Mouthdrying Ratings

Description

Perceived mouthdrying from whey protein beverages varying in protein levels using data from sensory methods (rating mouthdrying)

Time Frame

1 hour (sampled at visit one)

Title

Modulating mouthdrying

Description

Perceived mouthdrying from protein fortified scones varying in fat levels using data from sensory methods (rating mouthdrying as well as discrimination tests "which sample is more mouthdrying")

Time Frame

1 hour (sampled at visit one)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age (18-30 years or over 65 years) Healthy Exclusion Criteria: 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

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

32825104

Citation

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.

Results Reference

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PubMed Identifier

32967299

Citation

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.

Results Reference

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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

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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

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Learn more about this trial

Modifying Whey Protein Fortified Drinks and Foods

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