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Astringency and Oral Health

Primary Purpose

Saliva Altered, Taste, Altered

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Plain water
CPE
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Saliva Altered

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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 ScienceRecruiting

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 plain water-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 plain water-rinse period.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 28, 2022
Last Updated
May 1, 2023
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT05819073
Brief Title
Astringency and Oral Health
Official Title
Astringency Perception and Oral Health
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Saliva Altered, Taste, Altered

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (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 plain water-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 plain water-rinse period.
Intervention Type
Other
Intervention Name(s)
Plain water
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
Change from Baseline Taste and Flavor Intensity Ratings after 11 days
Description
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.
Time Frame
Baseline measure 3 days after control intervention; Post intervention measure 11 days after experimental intervention
Title
Change from Baseline Levels of Salivary Proteins after 11 days
Description
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.
Time Frame
Baseline measure 3 days after control intervention; Post intervention measure 11 days after experimental intervention
Title
Change from Baseline Composition of Oral Microbiome after 11 days
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 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.
Time Frame
Baseline measure 3 days after control intervention; Post intervention measure 11 days after experimental intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beverly J Tepper, Ph.D.
Phone
848-932-5417
Email
btepper@sebs.rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beverly J Tepper, Ph.D.
Organizational Affiliation
Rutgers University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers University, Department of Food Science
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beverly J Tepper, PhD
Phone
848-932-5417
Email
btepper@sebs.rutgers.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article after de-identification.
IPD Sharing Time Frame
Beginning three months and ending 5 years after publication.
IPD Sharing Access Criteria
Anyone who wishes to access the data. For any purpose.

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Astringency and Oral Health

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