Saliva AlteredNCT04107688
Taste Perception, Salivary Proteins & the Oral Microbiome
A study testing CPE in people with Saliva Altered and Taste, Altered, run by Rutgers University at 1 site in United States.
Trial summary
Genetic differences in taste are believed to play an important role in food selection, especially for strong-tasting foods and beverages. The overall goal of this project is to better understand how genes that control food preferences differ among people and whether saliva composition and oral health are related to… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Saliva Altered, Taste, Altered
- What is being tested?
- CPE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2019to 19 Apr 2019
- 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 45 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
Genetic differences in taste are believed to play an important role in food selection, especially for strong-tasting foods and beverages. The overall goal of this project is to better understand how genes that control food preferences differ among people and whether saliva composition and oral health are related to these differences.
This study examines the effects of a daily cranberry extract 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 (non-tasters of PROP; homozygous recessive for tas2R38 gene) or low-risk (super-taster of PROP; homozygous dominant for tas2R38 gene) of oral disease.
Read more
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 (see inclusion/exclusion criteria below). Each subject's period of participation will be 2 weeks. Days 1-3 of the study is a run-in period. Subjects 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 cranberry-derived polyphenol extract (CPE) in spring water. Saliva will be collected from subjects in a brief session (10 min) on Days 3 and Day 14. Saliva samples will be analyzed for 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 16S RNA sequencing. 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
- Control, CPE
- Keywords
- Oral Microbiome
- Medical subject headings
- Dysgeusia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
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 control-rinse period. Receives: Other: Control; 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 control-rinse period. Receives: Other: Control; Other: CPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste and Flavor Intensity Ratings
Taste and Flavor intensity ratings of cranberry 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: 3 days after control intervention; 11 days after experimental intervention
Levels of Salivary Proteins
Saliva will be collected 3 days after control intervention and then at the end of the experimental intervention. Samples will be analyzed via LCMS 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: 3 days after control intervention; 11 days after experimental intervention
Composition of Oral Microbiome
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 16S rRNA 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 genera level.
Measured: 3 days after control intervention; 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 posted27 Sep 2019
- Study start25 Mar 2019
- Primary completion19 Apr 2019
- Study completion19 Apr 2019
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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beverly J Tepper, Ph.D., Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107688
- Sponsor's protocol ID
- 13309M
- Status last verified
- May 2024
- First submitted
- 25 Apr 2019
- Last updated
- 14 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taste Perception, Salivary Proteins & the Oral Microbiome
- ClinicalTrials.gov ID
- NCT04107688
- Acronym / sponsor ID
- 13309M
- Conditions
- Saliva Altered, Taste, Altered
- Keywords
- Oral Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rutgers UniversityUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 19 Apr 2019 (actual)
- Study completion
- 19 Apr 2019 (actual)
- First posted
- 27 Sep 2019 (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.
Genetic differences in taste are believed to play an important role in food selection, especially for strong-tasting foods and beverages. The overall goal of this project is to better understand how genes that control food preferences differ among people and whether saliva composition and oral health are related to these differences.
This study examines the effects of a daily cranberry extract 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 (non-tasters of PROP; homozygous recessive for tas2R38 gene) or low-risk (super-taster of PROP; homozygous dominant for tas2R38 gene) of oral disease.
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 (see inclusion/exclusion criteria below). Each subject's period of participation will be 2 weeks. Days 1-3 of the study is a run-in period. Subjects 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 cranberry-derived polyphenol extract (CPE) in spring water. Saliva will be collected from subjects in a brief session (10 min) on Days 3 and Day 14. Saliva samples will be analyzed for 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 16S RNA sequencing. 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: Control, 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 control-rinse period. |
| PROP super-taster subjects | Experimental | Other: Control, 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 control-rinse period. |
Who may qualify
- Ages
- 18 to 45 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 |
|---|---|---|
| ControlSubjects 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
Taste and Flavor Intensity Ratings
Time frame: 3 days after control intervention; 11 days after experimental intervention
Taste and Flavor intensity ratings of cranberry 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.
Levels of Salivary Proteins
Time frame: 3 days after control intervention; 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 LCMS 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.
Composition of Oral Microbiome
Time frame: 3 days after control intervention; 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 16S rRNA 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 genera 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 14 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPE in people with Saliva Altered and Taste, Altered, run by Rutgers University 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 14 May 2024. 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?
Taste and Flavor Intensity Ratings (time frame: 3 days after control intervention; 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 14 May 2024.