- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04869722
Modifying Whey Protein Fortified Drinks and Foods
May 26, 2021 updated by: Lisa Methven, University of Reading
Modifying Whey Protein Fortified Drinks and Foods to Improve Perception, Whilst Accounting for Individual Differences in Age (At Home Study)
This study aims to investigate whether consumers differ in mouthdrying sensitivity and if mouthdrying can be modulated.
Study Overview
Status
Completed
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
116
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Reading, United Kingdom, RG66UR
- Sensory Science Centre, Department of Food and Nutritional Science, University of Reading, Reading, Berkshire, United Kingdom
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Liquid Model
Whey protein beverages varying in protein levels
|
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.
|
|
EXPERIMENTAL: Solid Model
Protein fortified scones varying in fat levels
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Whey Protein Beverages Mouthdrying Just Noticeable Difference Threshold
Time Frame: 1 hour (sampled at visit one)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Whey Protein Beverages Mouthdrying Ratings
Time Frame: 1 hour (sampled at visit one)
|
Perceived mouthdrying from whey protein beverages varying in protein levels using data from sensory methods (rating mouthdrying)
|
1 hour (sampled at visit one)
|
|
Modulating mouthdrying
Time Frame: 1 hour (sampled at visit one)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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, 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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 21, 2021
Primary Completion (ACTUAL)
May 15, 2021
Study Completion (ACTUAL)
May 15, 2021
Study Registration Dates
First Submitted
April 27, 2021
First Submitted That Met QC Criteria
April 27, 2021
First Posted (ACTUAL)
May 3, 2021
Study Record Updates
Last Update Posted (ACTUAL)
May 27, 2021
Last Update Submitted That Met QC Criteria
May 26, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UREC 20/35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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