Individual DifferenceNCT04507399
Investigating Consumers Perception and Acceptance of Whey Beverages
A study testing Liquid Model in people with Individual Difference and Food Sensitivity, run by University of Reading at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Individual Difference, Food Sensitivity, Food Preferences
- What is being tested?
- Liquid Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Aug 2020to 10 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- No food allergies or intolerances
- Non smokers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sensory Science Centre, Department of Food and Nutritional Science, University of Reading, Reading, Berkshire, United Kingdom
Reading, RG66UR
About this study
Brief Summary: This study aims to investigate whether protein fortification of beverages causes mouthdrying and mucoadhesion and whether this is influenced by saliva flow.
Read the 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.
- Conditions
- Individual Difference, Food Sensitivity, Food Preferences
- Being tested
- Liquid Model
- Keywords
- Mouthdrying, Saliva Flow, Mucoadhesion, Oral Nutritional Supplements
- Medical subject headings
- Food Intolerance, Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid ModelBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Protein Beverage | Experimental | Whey Protein Beverage Receives: Behavioral: Liquid Model |
| Control Beverage | Experimental | Whey Permeate Beverage Receives: Behavioral: Liquid Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Saliva collection and mouthdrying scoring throughout visits, 2 days
Secondary outcomes (3)
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.
Measured: 1 day (Sampled at study visit one)
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")
Measured: 1 day (Sampled at study visit one)
Saliva collection
Salivary flow rates from unstimulated and stimulated saliva samples.
Measured: 1 day (Sampled at study visit two)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start6 Aug 2020
- Primary completion10 Sep 2020
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Individual DifferenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study involves both a crossover design where each participant tastes both the control product and the protein fortified product with an appropriate break between the two sessions. The study will be conducted single blind as it not feasible to blind the researcher. Each participant will attend 2 study visits and all foods will be presented with random blinding codes.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Methven, University of Reading
- Investigators
- Lisa Methven, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507399
- Sponsor's protocol ID
- SCFP 32/20
- Status last verified
- Mar 2021
- First submitted
- 25 Jul 2020
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 28260840Withers 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.
PubMed 24092277Affoo 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.
PubMed 26456531Withers 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.
PubMed 24440265
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Consumers Perception and Acceptance of Whey Beverages
- ClinicalTrials.gov ID
- NCT04507399
- Acronym / sponsor ID
- SCFP 32/20
- Conditions
- Individual Difference, Food Sensitivity, Food Preferences
- Keywords
- Mouthdrying, Saliva Flow, Mucoadhesion, Oral Nutritional Supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brief Summary: This study aims to investigate whether protein fortification of beverages causes mouthdrying and mucoadhesion and whether this is influenced by saliva flow.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study involves both a crossover design where each participant tastes both the control product and the protein fortified product with an appropriate break between the two sessions. The study will be conducted single blind as it not feasible to blind the researcher. Each participant will attend 2 study visits and all foods will be presented with random blinding codes.
| Arm | Type | Receives |
|---|---|---|
| Protein Beverage | Experimental | Behavioral: Liquid ModelWhey Protein Beverage |
| Control Beverage | Experimental | Behavioral: Liquid ModelWhey Permeate Beverage |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy
- No food allergies or intolerances
- Non smokers
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid ModelTo 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. | Behavioural | Control Beverage, Protein Beverage |
Primary outcome
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.
3 secondary outcomes
Mouthdrying from whey beverages
Time frame: 1 day (Sampled at study visit one)
Manipulating saliva flow and mouthdrying from whey beverages
Time frame: 1 day (Sampled at study visit one)
Saliva collection
Time frame: 1 day (Sampled at study visit two)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Background: PubMed 28260840Bull 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.
- Background: PubMed 24092277Withers 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.
- Background: PubMed 26456531Affoo 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.
- Background: PubMed 24440265Withers 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Methven principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid Model in people with Individual Difference and Food Sensitivity, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucoadhesion and Mouthdrying (time frame: Saliva collection and mouthdrying scoring throughout visits, 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04507399, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2021.