N/A
N=15
Factors Controlling the Formation of Salivary Films
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01167504 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Impact of Ingredients on Thickness (Depth, nm) of Salivary Films Adsorbed Onto Solid Surfaces — 27 nm
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Saliva sample collection (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Quadram Institute Bioscience
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Impact of Ingredients on Thickness (Depth, nm) of Salivary Films Adsorbed Onto Solid Surfaces |
27 | — |
| SECONDARY Defined Behaviour of Salivary Film Formation |
868 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- Age: 18 - 65 years old
- Gender:Male or Female
- nonsmokers
Exclusion Criteria
- diabetics
- medical history of Tuberculosis or Hepatitis
- depressed or elevated blood pressure measurements ( 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT01167504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.