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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04869722
Other study ID # UREC 20/35
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 21, 2021
Est. completion date May 15, 2021

Study information

Verified date May 2021
Source University of Reading
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

1. To investigate whether older adults are more sensitive to whey protein derived mouthdrying compared with younger adults 2. To investigate whether increasing fat levels in a solid whey protein model influences mouthdrying perception


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date May 15, 2021
Est. primary completion date May 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Liquid Model
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.
Solid Model
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.

Locations

Country Name City State
United Kingdom Sensory Science Centre, Department of Food and Nutritional Science, University of Reading, Reading, Berkshire, United Kingdom Reading

Sponsors (2)

Lead Sponsor Collaborator
University of Reading Volac International Limited

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View 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). pii: E2506. doi: 10.3390/nu12092506. — View 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). pii: E1328. doi: 10.3390/foods9091328. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Whey Protein Beverages Mouthdrying Ratings Perceived mouthdrying from whey protein beverages varying in protein levels using data from sensory methods (rating mouthdrying) 1 hour (sampled at visit one)
Secondary 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") 1 hour (sampled at visit one)
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