Fruit-based Chewing Gums for Improving Oral Health

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05755152
• Collaborator: Wisconsin Alumni Research Foundation (Other)
• Enrollment: 10
• Arms: 2
• Anticipated Duration (Months): 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Health	Other: polyphenol-lecithin precipitate (PLP); Other: control formulation	N/A

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 30 minutes while providing 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Participants will be randomized to their first intervention and cross over to the second intervention.Participants will be randomized to their first intervention and cross over to the second intervention.
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Fruit-based Chewing Gums for Improving Oral Health
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cranberry PLP Chew the treatment chewing gum made with PLP for 30 minutes	Other: polyphenol-lecithin precipitate (PLP); Chewing gum made with material produced from patented technology to rapidly isolate polyphenols from fruit juice (PLP).
Experimental: Cranberry Extract Control Chew the control chewing gum made with Cranberry Extract for 30 minutes	Other: control formulation; Chewing gum made with material produced from conventional technology (e.g cranberry extract).

Outcome Measures

Primary Outcome Measures

1. Concentration of Polyphenols [Baseline before chewing gum; then 1 minute, 3 minutes, 6 minutes, 10 minutes, 15 minutes, 21 minutes after chewing gum]

   Participant saliva samples will be measured for polyphenol concentration.

Secondary Outcome Measures

1. pH [Baseline before chewing gum; then 6 minutes and 21 minutes after chewing gum]

   Participant saliva samples will be measured for pH.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Wisconsin, Madison
• Wisconsin Alumni Research Foundation

Investigators

• Principal Investigator: Bradley Bolling, PhD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT05755152
• Other Study ID Numbers: 2022-1703; Protocol Version 1/12/2023; Food Science; Discovery 2 Product
• First Posted: Mar 6, 2023
• Last Update Posted: Mar 10, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Wisconsin, Madison: Cranberry; Bioavailability; Polyphenol

Study Results

No Results Posted as of Mar 10, 2023