ClinicalTrials.Veeva

Menu

Astringency and Oral Health

Rutgers The State University of New Jersey logo

Rutgers The State University of New Jersey

Status

Completed

Conditions

Taste, Altered
Saliva Altered

Treatments

Other: CPE
Other: Plain water

Study type

Interventional

Funder types

Other

Identifiers

NCT05819073
Pro2022000271

Details and patient eligibility

About

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.

Full 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.

Enrollment

49 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

49 participants in 2 patient groups

PROP non-taster subjects
Experimental group
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.
Treatment:
Other: Plain water
Other: CPE
PROP super-taster subjects
Experimental group
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.
Treatment:
Other: Plain water
Other: CPE

Trial contacts and locations

1

Loading...

Central trial contact

Beverly J Tepper, Ph.D.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems