Fruit-based Chewing Gums for Improving Oral Health

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.

Study Overview

• Status: Completed
• Conditions: Oral Health
• Intervention / Treatment: Other: polyphenol-lecithin precipitate (PLP); Other: control formulation

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53706
      • Babcock Hall

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cranberry PLP; Chew the treatment chewing gum made with PLP at specific time intervals for a total of 60 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 at specific time intervals for a total of 60 minutes	Other: control formulation; Chewing gum made with material produced from conventional technology (e.g cranberry extract).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Polyphenols	Participant chewed gum samples will be measured for polyphenol concentration.	Baseline before chewing gum; then 1, 3, 6, 10, 15, 21 minutes after start of chewing gum.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pH	Participant saliva samples will be measured for pH.	Baseline before chewing gum and approximately 60 minutes after start of chewing gum.
Concentration of Polyphenols	Participant saliva samples will be measured for polyphenol concentration.	Baseline before chewing gum and approximately 60 minutes after start of chewing gum.

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Wisconsin Alumni Research Foundation
• Investigators: Principal Investigator: Bradley Bolling, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Actual): October 26, 2023
• Study Completion (Actual): October 26, 2023

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Bioavailability; Polyphenol; Cranberry
• Other Study ID Numbers: 2022-1703; Protocol Version 1/12/2023 (Other Identifier: UW Madison); Food Science (Other Identifier: UW Madison); Discovery 2 Product (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No