- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04507399
Investigating Consumers Perception and Acceptance of Whey Beverages
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Reading, United Kingdom, RG66UR
- Sensory Science Centre, Department of Food and Nutritional Science, University of Reading, Reading, Berkshire, United Kingdom
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Protein Beverage
Whey Protein Beverage
|
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. |
Experimental: Control Beverage
Whey Permeate Beverage
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mucoadhesion and Mouthdrying
Time Frame: Saliva collection and mouthdrying scoring throughout visits, 2 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mouthdrying from whey beverages
Time Frame: 1 day (Sampled at study visit one)
|
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)
|
Manipulating saliva flow and mouthdrying from whey beverages
Time Frame: 1 day (Sampled at study visit one)
|
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)
|
Saliva collection
Time Frame: 1 day (Sampled at study visit two)
|
Salivary flow rates from unstimulated and stimulated saliva samples.
|
1 day (Sampled at study visit two)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCFP 32/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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