Fruit-based Chewing Gums for Improving Oral Health

NCT05755152 | Completed

• 4 other identifiers: 2022-1703Protocol Version 1/12/2023Food ScienceDiscovery 2 Product
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Health

Keywords

Cranberry; Bioavailability; Polyphenol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• pH

  Baseline before chewing gum and approximately 60 minutes after start of chewing gum.

• Concentration of Polyphenols

  Baseline before chewing gum and approximately 60 minutes after start of chewing gum.

Study Arms (2)

Cranberry PLP

EXPERIMENTAL

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

Other: polyphenol-lecithin precipitate (PLP)

Cranberry Extract Control

EXPERIMENTAL

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

Other: control formulation

Interventions

polyphenol-lecithin precipitate (PLP) OTHER

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

Cranberry PLP

control formulation OTHER

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

Cranberry Extract Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Wisconsin Alumni Research Foundation: collaborator

Study Sites (1)

Babcock Hall

Madison, Wisconsin, 53706, United States

Location

Study Officials

• Bradley Bolling, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to their first intervention and cross over to the second intervention.

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 6, 2023
• Study Start: October 10, 2023
• Primary Completion: October 26, 2023
• Study Completion: October 26, 2023
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)