Clinical trial NCT05819073: Astringency and Oral Health
Official title: Astringency Perception and Oral Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Saliva Altered
Taste, Altered
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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: Change from Baseline Taste and Flavor Intensity Ratings after 11 days
timeFrame: Baseline measure 3 days after control intervention; Post intervention measure 11 days after experimental intervention
measure: Change from Baseline Levels of Salivary Proteins after 11 days
timeFrame: Baseline measure 3 days after control intervention; Post intervention measure 11 days after experimental intervention
measure: Change from Baseline Composition of Oral Microbiome after 11 days
timeFrame: Baseline measure 3 days after control intervention; Post intervention measure 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:
affiliation: Rutgers University
name: Beverly J Tepper, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: