Fruit-based Chewing Gums for Improving Oral Health

NCT ID: NCT05755152

Last Updated: 2023-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-10
• Study Completion Date: 2023-10-26

Brief Summary

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.

Detailed 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.

Conditions

Oral Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Cranberry PLP

Chew the treatment chewing gum made with PLP at specific time intervals for a total of 60 minutes

Group Type: EXPERIMENTAL

polyphenol-lecithin precipitate (PLP)

Intervention Type: OTHER

Chewing gum made with material produced from patented technology to rapidly isolate polyphenols from fruit juice (PLP).

Cranberry Extract Control

Chew the control chewing gum made with Cranberry Extract at specific time intervals for a total of 60 minutes

Group Type: EXPERIMENTAL

control formulation

Intervention Type: OTHER

Chewing gum made with material produced from conventional technology (e.g cranberry extract).

Interventions

polyphenol-lecithin precipitate (PLP)

Chewing gum made with material produced from patented technology to rapidly isolate polyphenols from fruit juice (PLP).

Intervention Type: OTHER

control formulation

Chewing gum made with material produced from conventional technology (e.g cranberry extract).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wisconsin Alumni Research Foundation

UNKNOWN

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bradley Bolling, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Babcock Hall

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

Protocol Version 1/12/2023

Identifier Type: OTHER

Identifier Source: secondary_id

Food Science

Identifier Type: OTHER

Identifier Source: secondary_id

Discovery 2 Product

Identifier Type: OTHER

Identifier Source: secondary_id

2022-1703

Identifier Type: -

Identifier Source: org_study_id