Clinical trial NCT04107688: Taste Perception, Salivary Proteins & the Oral Microbiome
Official title: Taste Perception, Salivary Proteins & the Oral Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Saliva Altered
Taste, Altered
Keywords: Oral Microbiome
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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:

1. alter the oral microbial profile
2. induce changes in the salivary protein response
3. 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.


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

Primary outcomes:
measure: Taste and Flavor Intensity Ratings
timeFrame: 3 days after control intervention; 11 days after experimental intervention
measure: Levels of Salivary Proteins
timeFrame: 3 days after control intervention; 11 days after experimental intervention
measure: Composition of Oral Microbiome
timeFrame: 3 days after control intervention; 11 days after experimental intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers University, Department of Food Science
state: New Jersey
Study officials:
References: