Astringency and Oral Health

NCT05819073 | Completed

• 1 other identifier: Pro2022000271
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Saliva Altered; Taste, Altered

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline measure 3 days after control intervention; Post intervention measure 11 days after experimental intervention

• 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.

  Baseline measure 3 days after control intervention; Post intervention measure 11 days after experimental intervention

• 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.

  Baseline measure 3 days after control intervention; Post intervention measure 11 days after experimental intervention

Study Arms (2)

PROP non-taster subjects

EXPERIMENTAL

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.

Other: Plain water; Other: CPE

PROP super-taster subjects

EXPERIMENTAL

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.

Other: Plain water; Other: CPE

Interventions

Plain water OTHER

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

PROP non-taster subjects; PROP super-taster subjects

CPE OTHER

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

PROP non-taster subjects; PROP super-taster subjects

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers University, Department of Food Science

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Dysgeusia

Condition Hierarchy (Ancestors)

Taste Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Beverly J Tepper, Ph.D.

  Rutgers University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: April 19, 2023
• Study Start: November 1, 2022
• Primary Completion: November 14, 2023
• Study Completion: November 14, 2023
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning three months and ending 5 years after publication.
• Access Criteria: Anyone who wishes to access the data. For any purpose.

Locations

US (1)