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The Use of Functional Confections in Promoting Oral Health

NCT01514552 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-10-17

No results posted yet for this study

Summary

In areas of the world where populations are undernourished poor oral health is prevalent. Diets rich in fruit and vegetables are thought to have many health benefits including reducing the risk of oral cancer or gum disease. In particular fruits such as strawberries contain many different compounds which may be responsible for these proposed health benefits.

From this study, the researchers hope to gain information about how the tissues in the mouth absorb strawberry gummies in a population of habitually smoking and never smoking men and women. The researchers will measure inflammation hormones in your saliva and urine and the genes in your mouth and blood. Two different strawberry gummies will be tested in this study. The strawberry gummies were developed at OSU in the Department of Food Science and Technology. One type of strawberry gummy will contain freeze-dried whole strawberries while the other type will have no fruit. In total the eight pieces of strawberry gummies that you will consume in one day will be at most equal to 1 cup of whole strawberries. The research team believes the two strawberry gummies may be digested and absorbed differently and that components in the strawberry gummies may be helpful for oral health.

Conditions

  • Oral Health
  • Oral Cancer
  • Gum Disease

Interventions

OTHER

Strawberry gummy

Randomized to consume 2 gummies (6 gram gummies each, total 12 grams/dose)four times daily for 7 days. Subjects will be randomized to either start with this strawberry intervention during intervention days 0 to 7 or during the crossover intervention on days 21 to 28.

OTHER

Placebo control gummy

Randomized to consume 2 gummies (6 gram gummies each, total 12 grams/dose)four times daily for 7 days. Subjects will be randomized to either start with this a placebo gummy intervention during intervention days 0 to 7 or during the crossover intervention on days 21 to 28.

Sponsors & Collaborators

  • Ohio State University

    lead OTHER

Principal Investigators

  • Yael Vodovotz, PhD. · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2026-04-10
Completion
2026-04-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01514552 on ClinicalTrials.gov