HealthySalFilmNCT01167504
Factors Controlling the Formation of Salivary Films
An observational study of Healthy, run by Quadram Institute Bioscience at 1 site in United Kingdom.
Trial summary
The aim of this study is to determine how different ingredients which are found in food and other consumer products affect the ability of saliva to form surface films. Saliva forms a protective film on the surfaces inside the mouth. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Saliva sample collection
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2010to Aug 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Apparently normal healthy volunteers from the local community able to donate saliva samples.
Who may be able to join
- Age: 18 - 65 years old
- Gender:Male or Female
- nonsmokers
Who cannot join
- diabetics
- medical history of Tuberculosis or Hepatitis
- depressed or elevated blood pressure measurements (<90/50 or <95/50 if symptomatic or >160/100).
- take any medication which may affect saliva production
- are related to someone in the study team i.e. spouse, partner or immediate family member
- are pregnant, planning to become pregnant, or are currently breastfeeding.
Show all 12Show fewer
- have results of the clinical screening which indicate, or are judged by the Human Nutrition Unit (HNU) Medical Advisor to be indicative of, a health problem which compromise the wellbeing of the volunteer if they participated, which would affect the study data.
- In addition, prior to each sample donation, the following conditions will be checked, and volunteers will only be allowed to donate saliva if none of the following apply:
- They have any current dental or mouth problems (bleeding gums, sores on mouth, dry mouth syndrome)
- They have had a viral illness or chest infection within last 7 days
- They are not able to produce sufficient saliva
- Volunteers will be required to avoid eating and drinking (except water) for 1 hour prior to saliva collection.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Food Research
Norwich, Norfolk, NR4 7UA
About this study
Official title: Investigating the Formation of Salivary Films and How They Change in the Presence of Ingredients From Food and Oral Hygiene Products
The aim of this study is to determine how different ingredients which are found in food and other consumer products affect the ability of saliva to form surface films.
Saliva forms a protective film on the surfaces inside the mouth. This film affects the way we consume and digest food and protects our teeth and other surfaces inside the mouth from disease and decay. It is not well known how this film forms, or which components in everyday life affect formation of the film, and therefore its protective properties.
Read more
Samples of saliva will be collected from apparently healthy volunteers. The properties of the film (thickness, density, strength, protein composition) will be studied in the laboratory under controlled conditions. The effects of common ingredients in foods and other products such as proteins, emulsifiers, preservatives and surfactants on the formation and properties of the film will be determined.
The results of this study will help us to understand how different ingredients can change the properties of saliva that may affect the way that we sense and digest food, and the ability of saliva to protect against decay and infection. This could, in the future lead to new ideas for developing:healthy foods (e.g. lower fat) that taste better, or more effective dental care products.
Read the detailed description
The aim of this study is to determine the physical and biochemical mechanisms responsible for the formation and structure development (in vitro) of the salivary mucous film and the impact of common ingredients found in food or oral hygiene products.
Saliva forms a film or pellicle on oral surfaces which serves as a protective barrier and lubricates the oral tissues during food consumption. However, it also provides the primary site for bacterial attachment and the build up of plaque. Therefore the physical and molecular structure of the salivary film is important for how we sense and taste food, how food is broken down in the mouth, and its effectiveness as a protective barrier. Much is known about the composition of saliva, but very little is known about the composition and structure of the salivary film or pellicle. We believe that the film formation and its physical properties, such as viscosity and strength are the result of complex interactions between different proteins within saliva, and with other components such as calcium and other salts, food components such as proteins and emulsifiers, and active compounds found in oral hygiene products such as preservatives and surfactants. This study will determine how the salivary film forms, its molecular composition and which other critical components affect its ability to form a stable, protective barrier. This knowledge will hopefully, in the future contribute to strategies to design healthier foods and more effective oral hygiene treatments.
The physical properties of saliva are not stable as the proteins tend to aggregate following secretion, which affects the length of time the film formation can be studied (ex vivo). Therefore we need to use fresh human saliva samples collected from healthy volunteers using a defined protocol to ensure sample quality, and assess them within four hours of collection. Saliva will be collected (either whole mouth or parotid), taken to the laboratory and allowed to form films on model surfaces, representative of those found in the mouth. The rate of formation, strength, thickness and mass of the films will be studied using a range of physical methods. The protein content and composition will also be determined to identify the components responsible for various stages of film formation. Then, the influence of environmental conditions such as pH, calcium and salt will be determined. Finally, we will determine how the films interact with external components found in food and oral hygiene products such as proteins, emulsifiers, preservatives and surfactants. Although we are not studying the effects of dietary intervention on saliva properties, we want to determine the underlying mechanisms responsible for film formation and break down. Paired T-tests will be used to compare parotid with whole mouth saliva from the same volunteers. Two sample T-tests will be used for comparison of similar measurements on samples from different volunteers. Diagnostic checks on results will be performed to check whether transformations are required to meet normality assumptions.
Two types of saliva samples will be collected: Whole Mouth Saliva (WMS) and Parotid Saliva (PS). The saliva will be stored at 4ºC (WMS may also be centrifuged at 2700xg for 20 minutes at 5°C to remove aggregates) and used within 4 hours of collection, as protein aggregation begins immediately after secretion, affecting the film formation properties, as determined in previous work. A range of physical techniques will be employed to determine the rate and extent of film formation, as well as the thickness, mass and rheological properties, under the different solution conditions and in the presence and absence of added ingredients as described above. Protein concentration and composition will also be determined. This will enable improved experimental design (e.g. normalising protein concentration) to improve the quality of the results. The results will be used to inform the design of further studies with other centres of expertise in order to understand the impact on in vivo behaviour of the salivary film and, for example the sensory perception of foods and the role of saliva on digestion of food structures.
- Conditions
- Healthy
- Being tested
- Saliva sample collection
- Keywords
- saliva, food, sensory, oral health, film, pellicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva sample collectionOther
Also called Whole mouth saliva, Parotid saliva
Collection of either whole mouth saliva or parotid saliva. Whole mouth saliva is collected through stimulation by inert gum. Parotid saliva is collected by using a Lashley cup placed over the parotid duct and stimulated by a fruit sweet.
| Study group | Role | What they receive |
|---|---|---|
| Saliva Sample Collection | Saliva collection Receives: Other: Saliva sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Ingredients on Thickness (Depth, nm) of Salivary Films Adsorbed Onto Solid Surfaces
The principal output is to determine how ingredients in food and oral hygiene products affect the way that saliva forms films on surfaces similar to those found inside the mouth. We will determine the main physical properties of the film such as thickness (nm), adsorbed mass (ng/cm^2), density (ng/cm^3) measured by adsorbing whole mouth saliva onto solid silica surfaces and measuring the above properties of the film using Dual Polarisation Interferometry and a Quartz Crystal Microbalance. The effect of ingredients from food and oral hygiene products on the above measured parameters will be determined.
Measured: Within 4 hours of saliva collection.
Secondary outcomes (1)
Defined Behaviour of Salivary Film Formation
A secondary output is a well defined description of the film formation behaviour of "normal"saliva in terms of thickness (nm), viscoelastic modulus (mN/m) and temporal behaviour. This will be used to develop model or artificial salivas saliva that forms films in the same way as real saliva ex vivo, that can be used to screen the effects of different compounds and ingredients, without having to collect fresh saliva from human volunteers. The measure is the rate of increase in film thickness (depth, nm) as a function of time, measured by adsorbing whole mouth saliva onto a solid silica surface and measuring the film thickness using Dual Polarisation Interferometry and Quartz Crystal Microbalance.
Measured: Within 4 hours of saliva collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies 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
- Observational
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quadram Institute Bioscience
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Peter J Wilde, PhD, Study director, Quadram Institute BioscienceMichael J Ridout, Principal investigator, Quadram Institute Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167504
- Sponsor's protocol ID
- IFR03-2010
- Acronym
- SalFilm
- Status last verified
- Nov 2013
- First submitted
- 20 Jul 2010
- Last updated
- 6 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Formation of Salivary Films and How They Change in the Presence of Ingredients From Food and Oral Hygiene Products
- ClinicalTrials.gov ID
- NCT01167504
- Acronym / sponsor ID
- SalFilm / IFR03-2010
- Conditions
- Healthy
- Keywords
- saliva, food, sensory, oral health, film, pellicle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Quadram Institute BioscienceUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jun 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 22 Jul 2010 (estimated)
- Results
- Posted 6 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine how different ingredients which are found in food and other consumer products affect the ability of saliva to form surface films.
Saliva forms a protective film on the surfaces inside the mouth. This film affects the way we consume and digest food and protects our teeth and other surfaces inside the mouth from disease and decay. It is not well known how this film forms, or which components in everyday life affect formation of the film, and therefore its protective properties.
Samples of saliva will be collected from apparently healthy volunteers. The properties of the film (thickness, density, strength, protein composition) will be studied in the laboratory under controlled conditions. The effects of common ingredients in foods and other products such as proteins, emulsifiers, preservatives and surfactants on the formation and properties of the film will be determined.
The results of this study will help us to understand how different ingredients can change the properties of saliva that may affect the way that we sense and digest food, and the ability of saliva to protect against decay and infection. This could, in the future lead to new ideas for developing:healthy foods (e.g. lower fat) that taste better, or more effective dental care products.
Detailed description
The aim of this study is to determine the physical and biochemical mechanisms responsible for the formation and structure development (in vitro) of the salivary mucous film and the impact of common ingredients found in food or oral hygiene products.
Saliva forms a film or pellicle on oral surfaces which serves as a protective barrier and lubricates the oral tissues during food consumption. However, it also provides the primary site for bacterial attachment and the build up of plaque. Therefore the physical and molecular structure of the salivary film is important for how we sense and taste food, how food is broken down in the mouth, and its effectiveness as a protective barrier. Much is known about the composition of saliva, but very little is known about the composition and structure of the salivary film or pellicle. We believe that the film formation and its physical properties, such as viscosity and strength are the result of complex interactions between different proteins within saliva, and with other components such as calcium and other salts, food components such as proteins and emulsifiers, and active compounds found in oral hygiene products such as preservatives and surfactants. This study will determine how the salivary film forms, its molecular composition and which other critical components affect its ability to form a stable, protective barrier. This knowledge will hopefully, in the future contribute to strategies to design healthier foods and more effective oral hygiene treatments.
The physical properties of saliva are not stable as the proteins tend to aggregate following secretion, which affects the length of time the film formation can be studied (ex vivo). Therefore we need to use fresh human saliva samples collected from healthy volunteers using a defined protocol to ensure sample quality, and assess them within four hours of collection. Saliva will be collected (either whole mouth or parotid), taken to the laboratory and allowed to form films on model surfaces, representative of those found in the mouth. The rate of formation, strength, thickness and mass of the films will be studied using a range of physical methods. The protein content and composition will also be determined to identify the components responsible for various stages of film formation. Then, the influence of environmental conditions such as pH, calcium and salt will be determined. Finally, we will determine how the films interact with external components found in food and oral hygiene products such as proteins, emulsifiers, preservatives and surfactants. Although we are not studying the effects of dietary intervention on saliva properties, we want to determine the underlying mechanisms responsible for film formation and break down. Paired T-tests will be used to compare parotid with whole mouth saliva from the same volunteers. Two sample T-tests will be used for comparison of similar measurements on samples from different volunteers. Diagnostic checks on results will be performed to check whether transformations are required to meet normality assumptions.
Two types of saliva samples will be collected: Whole Mouth Saliva (WMS) and Parotid Saliva (PS). The saliva will be stored at 4ºC (WMS may also be centrifuged at 2700xg for 20 minutes at 5°C to remove aggregates) and used within 4 hours of collection, as protein aggregation begins immediately after secretion, affecting the film formation properties, as determined in previous work. A range of physical techniques will be employed to determine the rate and extent of film formation, as well as the thickness, mass and rheological properties, under the different solution conditions and in the presence and absence of added ingredients as described above. Protein concentration and composition will also be determined. This will enable improved experimental design (e.g. normalising protein concentration) to improve the quality of the results. The results will be used to inform the design of further studies with other centres of expertise in order to understand the impact on in vivo behaviour of the salivary film and, for example the sensory perception of foods and the role of saliva on digestion of food structures.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Saliva Sample Collection | – | Other: Saliva sample collectionSaliva collection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Apparently normal healthy volunteers from the local community able to donate saliva samples.
Key inclusion criteria (3 listed)
- Age: 18 - 65 years old
- Gender:Male or Female
- nonsmokers
Key exclusion criteria (12 listed)
- diabetics
- medical history of Tuberculosis or Hepatitis
- depressed or elevated blood pressure measurements (<90/50 or <95/50 if symptomatic or >160/100).
- take any medication which may affect saliva production
- are related to someone in the study team i.e. spouse, partner or immediate family member
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 |
|---|---|---|
| Saliva sample collectionAlso: Whole mouth saliva, Parotid salivaCollection of either whole mouth saliva or parotid saliva. Whole mouth saliva is collected through stimulation by inert gum. Parotid saliva is collected by using a Lashley cup placed over the parotid duct and stimulated by a fruit sweet. | Other | Saliva Sample Collection |
Primary outcome
Impact of Ingredients on Thickness (Depth, nm) of Salivary Films Adsorbed Onto Solid Surfaces
Time frame: Within 4 hours of saliva collection.
The principal output is to determine how ingredients in food and oral hygiene products affect the way that saliva forms films on surfaces similar to those found inside the mouth. We will determine the main physical properties of the film such as thickness (nm), adsorbed mass (ng/cm^2), density (ng/cm^3) measured by adsorbing whole mouth saliva onto solid silica surfaces and measuring the above properties of the film using Dual Polarisation Interferometry and a Quartz Crystal Microbalance. The effect of ingredients from food and oral hygiene products on the above measured parameters will be determined.
1 secondary outcome
Defined Behaviour of Salivary Film Formation
Time frame: Within 4 hours of saliva collection.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Peter J Wilde, PhD study director
Quadram Institute Bioscience
Michael J Ridout principal investigator
Quadram Institute Bioscience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Quadram Institute Bioscience 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 12 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 6 Jan 2014. 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?
Yes. Results are posted in the registry (first posted 6 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Impact of Ingredients on Thickness (Depth, nm) of Salivary Films Adsorbed Onto Solid Surfaces (time frame: Within 4 hours of saliva collection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2014.