Taste Perception, Salivary Proteins & the Oral Microbiome
Primary Purpose
Saliva Altered, Taste, Altered
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control
CPE
Sponsored by
About this trial
This is an interventional basic science trial for Saliva Altered focused on measuring Oral Microbiome
Eligibility Criteria
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
Sites / Locations
- Rutgers University, Department of Food Science
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PROP non-taster subjects
PROP super-taster subjects
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04107688
Brief Title
Taste Perception, Salivary Proteins & the Oral Microbiome
Official Title
Taste Perception, Salivary Proteins & the Oral Microbiome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Saliva Altered, Taste, Altered
Keywords
Oral Microbiome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PROP non-taster subjects
Arm Type
Experimental
Arm Description
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.
Arm Title
PROP super-taster subjects
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Subjects will use plain water as an oral rinse twice a day for 3 days.
Intervention Type
Other
Intervention Name(s)
CPE
Intervention Description
Subjects will use a cranberry-derived oral rinse twice a day for 11 days.
Primary Outcome Measure Information:
Title
Taste and Flavor Intensity Ratings
Description
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.
Time Frame
3 days after control intervention; 11 days after experimental intervention
Title
Levels of Salivary Proteins
Description
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.
Time Frame
3 days after control intervention; 11 days after experimental intervention
Title
Composition of Oral Microbiome
Description
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.
Time Frame
3 days after control intervention; 11 days after experimental intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Rutgers University, Department of Food Science
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
12. IPD Sharing Statement
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Taste Perception, Salivary Proteins & the Oral Microbiome
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