Taste Perception, Salivary Proteins & the Oral Microbiome

NCT ID: NCT04107688

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-25
• Study Completion Date: 2019-04-19

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.

Conditions

Saliva Altered; Taste, Altered

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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 control-rinse period.

Group Type: EXPERIMENTAL

Control

Intervention Type: OTHER

Subjects will use plain water as an oral rinse twice a day for 3 days.

CPE

Intervention Type: OTHER

Subjects will use a cranberry-derived oral rinse twice a day for 11 days.

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 control-rinse period.

Group Type: EXPERIMENTAL

Control

Intervention Type: OTHER

Subjects will use plain water as an oral rinse twice a day for 3 days.

CPE

Intervention Type: OTHER

Subjects will use a cranberry-derived oral rinse twice a day for 11 days.

Interventions

Control

Subjects will use plain water as an oral rinse twice a day for 3 days.

Intervention Type: OTHER

CPE

Subjects will use a cranberry-derived oral rinse twice a day for 11 days.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rutgers University

OTHER

Sponsor Role: lead

Responsible Party

Beverly J Tepper, Ph.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rutgers University, Department of Food Science

New Brunswick, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

13309M

Identifier Type: -

Identifier Source: org_study_id