Astringency and Oral Health

NCT ID: NCT05819073

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-11-14

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:

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. 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.

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 plain water-rinse period.

Group Type: EXPERIMENTAL

Plain water

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 plain water-rinse period.

Group Type: EXPERIMENTAL

Plain water

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

Plain water

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: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Beverly J Tepper, Ph.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Beverly J Tepper, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Rutgers University

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

Pro2022000271

Identifier Type: -

Identifier Source: org_study_id