- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05819073
Astringency and Oral Health
Astringency Perception and Oral Health
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
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New Brunswick, New Jersey, United States, 08901
- Rutgers University, Department of Food Science
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PROP non-taster subjects
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.
|
Subjects will use a cranberry-derived oral rinse twice a day for 11 days.
Subjects will use plain water as an oral rinse twice a day for 3 days.
|
|
Experimental: PROP super-taster subjects
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.
|
Subjects will use a cranberry-derived oral rinse twice a day for 11 days.
Subjects will use plain water as an oral rinse twice a day for 3 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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.
|
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
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.
|
Baseline measure 3 days after control intervention; Post intervention measure 11 days after experimental intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Beverly J Tepper, Ph.D., Rutgers University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro2022000271
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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