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NCT01514552 · ClinicalTrials.gov registry record · Phase 1
The Use of Functional Confections in Promoting Oral Health
A Phase 1 study of Oral Cancer and Oral Health, sponsored by Ohio State University.
- Active
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT01514552: Active Phase 1 study of Oral Cancer and Oral Health, sponsored by Ohio State University.
NCT01514552 is a Phase 1 study of Oral Cancer and Oral Health that is active but no longer recruiting, run by Ohio State University. The registered enrollment target is 36 participants, below the 211-participant average among 17 other Oral Cancer trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01514552, a Phase 1 study of Oral Cancer and Oral Health, is active but no longer recruiting, sponsored by Ohio State University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Daily records of consumption will be maintained. Standardized qualitative and quantitative toxicity criteria (NIH Common Terminology Criteria for Adverse Events, v. 3.0) will be employed to describe the safety as well as incidence toxicity
Conditions Studied
Interventions
- OTHER Strawberry gummy
- OTHER Placebo control gummy
Study Locations (1)
Ohio
- The Ohio State University - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2010-11 |
| Est. Completion | 2026-04-10 |
| Phase | Phase 1 |
What the registry record for NCT01514552 still lists
NCT01514552 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 211-participant average among 17 other Oral Cancer trials with a reported enrollment target (83% lower).
The record links to 3 conditions, with Oral Cancer appearing as the primary indexed condition, and to 2 interventions - of which Strawberry gummy is the first listed.
NCT01514552 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT01514552 about?
NCT01514552 is a clinical study titled "The Use of Functional Confections in Promoting Oral Health". 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 ...
What is the current status of trial NCT01514552?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2010-11. Estimated completion is 2026-04-10.
What conditions does trial NCT01514552 study?
This clinical trial studies the following conditions: Oral Cancer, Oral Health, Gum Disease.
What interventions are being tested in trial NCT01514552?
The interventions under investigation include: Strawberry gummy (OTHER), Placebo control gummy (OTHER).
Who is sponsoring clinical trial NCT01514552?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01514552 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01514552's enrollment target sits among peer trials
36 16th of 17 higher than 2 of 17 other Oral Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Oral Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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