Fruit-based Chewing Gums for Improving Oral Health

University of Wisconsin (UW)

Status

Completed

Conditions

Oral Health

Treatments

Other: control formulation

Other: polyphenol-lecithin precipitate (PLP)

Study type

Interventional

Funder types

Other

Identifiers

NCT05755152

Food Science (Other Identifier)

Discovery 2 Product (Other Identifier)

Protocol Version 1/12/2023 (Other Identifier)

2022-1703

Details and patient eligibility

About

This study aims to conduct a randomized cross-over study investigating the release of cranberry polyphenols from chewing gum formulated with polyphenol-lecithin precipitate (PLP). 10 participants will be on study for up to 2 weeks and will each complete 2-30 minute study intervention visits.

Full description

This study is intended to evaluate the bioavailability of a dietary supplement, cranberry PLP, compared to another dietary ingredient, cranberry extract. The intent of the evaluation is to provide preliminary data for future evaluation of cranberry PLP on the normal structure or function in humans, which includes the effect of cranberry PLP on oral health.

Participants will be asked to refrain from eating, drinking, or using tobacco products, and vigorous exercise for 1 hour before the intervention period. Participants will also be asked to avoid chewing gum 48 hours before the intervention. Water is acceptable up until 10 minutes before sample collection. Participants will be given these instructions during the informed consent process, and will be sent a reminder email about study protocols at least 72 hours in advance of the study visit. If their second visit is 48 hours after their first, the investigators will remind them of these restrictions at the end of their first visit.

On the day of each intervention and sampling period, participants will be asked to visit the Bolling Laboratory at the Department of Food Science adhering to the dietary guidance described above. Participants with appliances or dentures will be asked to remove them during sampling periods. Then, participants will chew the intervention or control gum for a total of 60 minutes while providing chewed gum and saliva samples at specified intervals throughout this time. Participants will come back to the Bolling Laboratory at a later time, a minimum of 48 hours after the last sampling period, to chew the other gum in the same manner as the first sampling period.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

healthy adults 18 years and older
willing to avoid foods, beverages, tobacco products, and additional gum in the wash-in and wash-out periods
willing to chew the intervention gum during the sampling periods
willing to provide saliva and gum samples during the sampling periods
willing to fill out post-visit surveys after their visits

Exclusion criteria

Participants who do not consider themselves healthy
have less than 20 natural teeth and 8 natural posterior teeth (excluding third molars)
have a salivary rate ≥ 0.3 mL/min as determined from an unstimulated salivary flow trial
taking medications that contraindicates grapefruit juice consumption
allergic to any intervention foods or ingredients (e.g. sunflower, soy, food colorants, berry ingredients, or any other component of the study gum)
diagnosed with phenylketonuria (PKU), gross untreated caries, advanced gingivitis and periodontitis, and temporomandibular joint disorder
participants who are pregnant or lactating