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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04302779
Other study ID # UREC 19/67
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 13, 2020
Est. completion date March 19, 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 foods and beverages causes mouthdrying and mucoadhesion and whether this is influenced by age and saliva flow.


Description:

To investigate whether whey protein beverages cause mouthdrying in older adults and if perception and acceptance are influenced by repeated consumption, age and individual differences in saliva flow. To investigate whether protein fortification of cupcakes causes mouthdrying and if perception and acceptance are influenced by repeated consumption, age and individual differences in saliva flow in a home environment. To investigate whether mucoadhesion is present within different food models, if sensitivity to mucoadhesion increases with age and to determine if a reduced salivary flow results in strengthened mucoadhesion.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date March 19, 2020
Est. primary completion date March 19, 2020
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: - Cognitively impaired - Allergies, intolerance and special dietary requirements (for example coeliac disease, lactose / gluten intolerance) - Suffer from diabetes - Oral surgery - Stroke - Smoker - Cancer

Study Design


Intervention

Behavioral:
Solid Model
Cupcakes will be used, with the amount of protein varied to study the effect on perception of the products (using sensory methods rating drying and discrimination tests 'which is the stronger in drying'). Measuring mucoadhesion via protein content remaining in saliva samples following consumption of cupcakes.
Liquid Model
To study the perception of whey protein beverages using repeated consumption sensory methods (e.g. rating mouthdrying over repeated sips of the drink).

Locations

Country Name City State
United Kingdom Sensory Science Centre, University of Reading Reading

Sponsors (1)

Lead Sponsor Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

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

Gosney M. Are we wasting our money on food supplements in elder care wards? J Adv Nurs. 2003 Aug;43(3):275-80. — View Citation

Kennedy O, Law C, Methven L, Mottram D, Gosney M. Investigating age-related changes in taste and affects on sensory perceptions of oral nutritional supplements. Age Ageing. 2010 Nov;39(6):733-8. doi: 10.1093/ageing/afq104. Epub 2010 Sep 22. — 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 Ex-vivo analysis using cupcakes (whey permeate and whey protein) (expectorated saliva collection to analyse protein for the extent of mucoadhesion) Change in protein left in mouth over from baseline to after consumption (45s)
Secondary Mouthdrying from cupcakes Perceived mouth drying from protein fortified lemon cupcake and whey permeate lemon cupcake using data from repeated consumption sensory methods (rating drying on line scales) Change in perceived mouthdruing from baseline over consumption (5 minutes)
Secondary Mouthdrying from whey protein beverages Perceived mouth drying from whey protein beverage using data from repeated consumption sensory methods (rating drying on line scales) Change in perceived mouthdruing from baseline over consumption (20 minutes)
Secondary Saliva Collection Salivary flow rates from unstimulated and stimulated saliva samples Days 1 and 2
Secondary Questionnaire Dental status, mouth behaviour, attitudes and portion size data via a questionnaire Day 1
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