An interventional study of Plain water and CPE in Saliva Altered and Taste, Altered, sponsored by Rutgers, The State University of New Jersey. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Basic science
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.
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:
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.
52 studies on the registry are indexed under Dysgeusia; 12 are open to participants now.
This study's enrollment of 49 is close to the median of 49 across 28 interventional studies indexed under Dysgeusia.
Browse Dysgeusia studies →Rutgers, The State University of New Jersey is the lead sponsor of 506 studies on the registry; 131 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 31 (79%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Subjects will use plain water as an oral rinse twice a day for 3 days.
Subjects will use a cranberry-derived oral rinse twice a day for 11 days.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline measure 3 days after control intervention; Post intervention measure 11 days after experimental intervention
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Individual participant data that underlie the results reported in this article after de-identification.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning three months and ending 5 years after publication.
Access criteria: Anyone who wishes to access the data. For any purpose.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Rutgers, The State University of New Jersey →