Saliva AlteredNCT05819073
Astringency and Oral Health
A study testing Plain water and CPE in people with Saliva Altered and Taste, Altered, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The perception of astringency is thought to involve the interaction between tannins and salivary proteins. However, the mechanisms underlying this interaction are poorly understood. The tannins' subclass known as type A proanthocyanidins seems to have a positive effect on human health. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Saliva Altered, Taste, Altered
- What is being tested?
- Plain water and CPE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 14 Nov 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- PROP insensitive individuals (PROP non-tasters; homozygous recessive for TAS2R38 gene)
- PROP high-sensitive individuals (PROP super-tasters; homozygous dominant for TAS2R38 gene)
- Overall healthy; good oral health and hygiene routine
- Current on a routine checkup by a oral/dental health professional
- Recently underwent dental/cleaning by a oral/dental health professional
- No ongoing oral health problems
- Agree to use intervention material as prescribed
- Agree to refrain from using any other oral rinse material during the term of the study
Who cannot join
- PROP medium-taster individuals (heterozygous for TAS2R38 gene)
- Taste or smell dysfunction
- Pregnant or nursing
- Oral piercings
- Smoking
- Use of medications other than birth control
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers University, Department of Food Science
New Brunswick, New Jersey, 08901
About this study
Official title: Astringency Perception and Oral Health
The perception of astringency is thought to involve the interaction between tannins and salivary proteins. However, the mechanisms underlying this interaction are poorly understood. The tannins' subclass known as type A proanthocyanidins seems to have a positive effect on human health. Despite that, humans show large individual differences in the sensory perception and acceptance of astringent foods such as tea, wine and chocolate suggesting that this variation may have a genetic basis. Salivary proteins play an essential role both in affecting oral taste perception and in maintaining a healthy oral environment. Diverse microorganisms inhabit the oral cavity. The interactions between oral microbiota, host and environmental factors influence microbial homeostasis and ultimately human oral health. Understanding individual differences in salivary proteins, oral microbiome and the mechanisms by which tannins evoke the perception of astringency could provide important insights into the role of these compounds in human nutrition and health.
Read the detailed description
This study examines the effects of a daily Cranberry Polyphenol Extract (CPE) oral rinse on salivary protein responses and the oral microbiome (as a proxy measure of oral health). The study will be conducted in healthy adults who are presumably at high-risk or low-risk of oral disease. High risk individuals include non-tasters of PROP (6-n-propylthiouracil) and homozygous recessive for TAS2R38 (Taste 2 Receptor Member 38) gene, while low-risk individuals include super-tasters of PROP and homozygous dominant for TAS2R38 gene.
The specific aims are to determine if the use of cranberry polyphenol extract rinse will:
- alter the oral microbial profile
- induce changes in the salivary protein response
- be associated with changes in taste and flavor perception
Participants will be screened for good overall and oral health. Each subject's period of participation will be 2 weeks. Days 1-3 of the study is a run-in period. Subjects will rinse with spring water 2-times/day (after brushing their teeth in the morning and evening). During days 4-14, subjects will rinse in a similar manner with a solution of CPE in spring water. Saliva will be collected from subjects in a brief session (10 min) on day 1, day 3, and day 14. Saliva samples will be analyzed for gene, salivary proteins and microbial profile analysis. The purpose of this analysis is to measure the relative ratios of beneficial vs. disease-causing microbes in the mouth using microbial whole-genome sequencing (WGS). On each of the testing days, subjects will also evaluate food samples for standard taste and flavor attributes.
- Conditions
- Saliva Altered, Taste, Altered
- Being tested
- Plain water, CPE
- Medical subject headings
- Dysgeusia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plain waterOther
Subjects will use plain water as an oral rinse twice a day for 3 days.
CPEOther
Subjects will use a cranberry-derived oral rinse twice a day for 11 days.
| Study group | Role | What they receive |
|---|---|---|
| PROP non-taster subjects | Experimental | This arm will comprise of PROP non-taster subjects. Subjects will use a cranberry-derived oral rinse twice a day for 11 days following a 3-day plain water-rinse period. Receives: Other: Plain water; Other: CPE |
| PROP super-taster subjects | Experimental | This arm will comprise of PROP super-taster subjects. Subjects will use a cranberry-derived oral rinse twice a day for 11 days following a 3-day plain water-rinse period. Receives: Other: Plain water; Other: CPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Taste and Flavor Intensity Ratings after 11 days
Taste and flavor intensity ratings of cranberry juice and aronia juice samples will be collected 3 days after control intervention and then at the end of the experimental intervention. An end-anchored (None, Very Strong) 15 cm line scale will be used with taste and key flavor attributes.
Measured: Baseline measure 3 days after control intervention; Post intervention measure 11 days after experimental intervention
Change from Baseline Levels of Salivary Proteins after 11 days
Saliva will be collected 3 days after control intervention and then at the end of the experimental intervention. Samples will be analyzed via dot blot analysis and LC-MS (liquid chromatography-mass spectrometry) to establish proteomic composition before and after the intervention. Specifically, area of the ion current peaks (XIC peaks) generated will be used as a relative quantity of the salivary protein levels. The XIC peaks are proportional to the concentration of salivary proteins under constant conditions and will be used to understand the effect of the intervention on salivary protein levels.
Measured: Baseline measure 3 days after control intervention; Post intervention measure 11 days after experimental intervention
Change from Baseline Composition of Oral Microbiome after 11 days
Salivary samples will be collected 3 days after control intervention and then at the end of the experimental intervention. Samples will be analyzed for microbial composition via Whole Genome Sequencing and data used to understand changes in microbial diversity before and after the intervention. Specifically operational taxonomic units will be identified and classified at the species level.
Measured: Baseline measure 3 days after control intervention; Post intervention measure 11 days after experimental intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 Nov 2022
- Primary completion14 Nov 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Saliva AlteredStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beverly J Tepper, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Beverly J Tepper, Ph.D., Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819073
- Sponsor's protocol ID
- Pro2022000271
- Status last verified
- Mar 2025
- First submitted
- 28 Oct 2022
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article after de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Astringency Perception and Oral Health
- ClinicalTrials.gov ID
- NCT05819073
- Acronym / sponsor ID
- Pro2022000271
- Conditions
- Saliva Altered, Taste, Altered
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 19 Apr 2023 (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.
The perception of astringency is thought to involve the interaction between tannins and salivary proteins. However, the mechanisms underlying this interaction are poorly understood. The tannins' subclass known as type A proanthocyanidins seems to have a positive effect on human health. Despite that, humans show large individual differences in the sensory perception and acceptance of astringent foods such as tea, wine and chocolate suggesting that this variation may have a genetic basis. Salivary proteins play an essential role both in affecting oral taste perception and in maintaining a healthy oral environment. Diverse microorganisms inhabit the oral cavity. The interactions between oral microbiota, host and environmental factors influence microbial homeostasis and ultimately human oral health. Understanding individual differences in salivary proteins, oral microbiome and the mechanisms by which tannins evoke the perception of astringency could provide important insights into the role of these compounds in human nutrition and health.
Detailed description
This study examines the effects of a daily Cranberry Polyphenol Extract (CPE) oral rinse on salivary protein responses and the oral microbiome (as a proxy measure of oral health). The study will be conducted in healthy adults who are presumably at high-risk or low-risk of oral disease. High risk individuals include non-tasters of PROP (6-n-propylthiouracil) and homozygous recessive for TAS2R38 (Taste 2 Receptor Member 38) gene, while low-risk individuals include super-tasters of PROP and homozygous dominant for TAS2R38 gene.
The specific aims are to determine if the use of cranberry polyphenol extract rinse will:
- alter the oral microbial profile
- induce changes in the salivary protein response
- be associated with changes in taste and flavor perception
Participants will be screened for good overall and oral health. Each subject's period of participation will be 2 weeks. Days 1-3 of the study is a run-in period. Subjects will rinse with spring water 2-times/day (after brushing their teeth in the morning and evening). During days 4-14, subjects will rinse in a similar manner with a solution of CPE in spring water. Saliva will be collected from subjects in a brief session (10 min) on day 1, day 3, and day 14. Saliva samples will be analyzed for gene, salivary proteins and microbial profile analysis. The purpose of this analysis is to measure the relative ratios of beneficial vs. disease-causing microbes in the mouth using microbial whole-genome sequencing (WGS). On each of the testing days, subjects will also evaluate food samples for standard taste and flavor attributes.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROP non-taster subjects | Experimental | Other: Plain water, Other: CPEThis arm will comprise of PROP non-taster subjects. Subjects will use a cranberry-derived oral rinse twice a day for 11 days following a 3-day plain water-rinse period. |
| PROP super-taster subjects | Experimental | Other: Plain water, Other: CPEThis arm will comprise of PROP super-taster subjects. Subjects will use a cranberry-derived oral rinse twice a day for 11 days following a 3-day plain water-rinse period. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- PROP insensitive individuals (PROP non-tasters; homozygous recessive for TAS2R38 gene)
- PROP high-sensitive individuals (PROP super-tasters; homozygous dominant for TAS2R38 gene)
- Overall healthy; good oral health and hygiene routine
- Current on a routine checkup by a oral/dental health professional
- Recently underwent dental/cleaning by a oral/dental health professional
Key exclusion criteria (6 listed)
- PROP medium-taster individuals (heterozygous for TAS2R38 gene)
- Taste or smell dysfunction
- Pregnant or nursing
- Oral piercings
- Smoking
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 |
|---|---|---|
| Plain waterSubjects will use plain water as an oral rinse twice a day for 3 days. | Other | PROP non-taster subjects, PROP super-taster subjects |
| CPESubjects will use a cranberry-derived oral rinse twice a day for 11 days. | Other | PROP non-taster subjects, PROP super-taster subjects |
Primary outcome
Change from Baseline Taste and Flavor Intensity Ratings after 11 days
Time frame: Baseline measure 3 days after control intervention; Post intervention measure 11 days after experimental intervention
Taste and flavor intensity ratings of cranberry juice and aronia juice samples will be collected 3 days after control intervention and then at the end of the experimental intervention. An end-anchored (None, Very Strong) 15 cm line scale will be used with taste and key flavor attributes.
Change from Baseline Levels of Salivary Proteins after 11 days
Time frame: Baseline measure 3 days after control intervention; Post intervention measure 11 days after experimental intervention
Saliva will be collected 3 days after control intervention and then at the end of the experimental intervention. Samples will be analyzed via dot blot analysis and LC-MS (liquid chromatography-mass spectrometry) to establish proteomic composition before and after the intervention. Specifically, area of the ion current peaks (XIC peaks) generated will be used as a relative quantity of the salivary protein levels. The XIC peaks are proportional to the concentration of salivary proteins under constant conditions and will be used to understand the effect of the intervention on salivary protein levels.
Change from Baseline Composition of Oral Microbiome after 11 days
Time frame: Baseline measure 3 days after control intervention; Post intervention measure 11 days after experimental intervention
Salivary samples will be collected 3 days after control intervention and then at the end of the experimental intervention. Samples will be analyzed for microbial composition via Whole Genome Sequencing and data used to understand changes in microbial diversity before and after the intervention. Specifically operational taxonomic units will be identified and classified at the species level.
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 28 Mar 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article after de-identification.
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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.
Beverly J Tepper, Ph.D. principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plain water and CPE in people with Saliva Altered and Taste, Altered, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 8 inclusion and 6 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 28 Mar 2025. 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 States. 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?
Change from Baseline Taste and Flavor Intensity Ratings after 11 days (time frame: Baseline measure 3 days after control intervention; Post intervention measure 11 days after experimental intervention). The study lists 3 primary outcomes in all. 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 28 Mar 2025.