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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04507399
Other study ID # SCFP 32/20
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 6, 2020
Est. completion date September 10, 2020

Study information

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

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 10, 2020
Est. primary completion date September 10, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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

Study Design


Intervention

Behavioral:
Liquid Model
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.

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 (1)

Lead Sponsor Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. — View 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. — View 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. — 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 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 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. 1 day (Sampled at study visit one)
Secondary 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") 1 day (Sampled at study visit one)
Secondary Saliva collection Salivary flow rates from unstimulated and stimulated saliva samples. 1 day (Sampled at study visit two)
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