Taste Perception, Salivary Proteins & the Oral Microbiome

NCT04107688 | Completed

• 1 other identifier: 13309M
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.alter the oral microbial profile
2. 2.induce changes in the salivary protein response
3. 3.be associated with changes in taste and flavor perception

Conditions

Saliva Altered; Taste, Altered

Keywords

Oral Microbiome

Outcome Measures

Primary Outcomes (3)

• Taste and Flavor Intensity Ratings

  Taste and Flavor intensity ratings of cranberry 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.

  3 days after control intervention; 11 days after experimental intervention

• Levels of Salivary Proteins

  Saliva will be collected 3 days after control intervention and then at the end of the experimental intervention. Samples will be analyzed via LCMS 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.

  3 days after control intervention; 11 days after experimental intervention

• Composition of Oral Microbiome

  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 16S rRNA 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 genera level.

  3 days after control intervention; 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 control-rinse period.

Other: Control; 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 control-rinse period.

Other: Control; Other: CPE

Interventions

Control 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 - 45 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 University: 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 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: April 25, 2019
• First Posted: September 27, 2019
• Study Start: March 25, 2019
• Primary Completion: April 19, 2019
• Study Completion: April 19, 2019
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

US (1)