Oral HealthPhase 1NCT01514552
The Use of Functional Confections in Promoting Oral Health
A Phase 1 study testing Strawberry gummy in people with Oral Health and Oral Cancer, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health, Oral Cancer, Gum Disease
- What is being tested?
- Strawberry gummy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to 10 Apr 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Submit to a 24 hour urine cotinine test which will be used to determine smoking status.
- Meet one of the following smoking criteria
- Non-smoker
- Does not currently smoke or has no history of smoking or using tobacco related products (cigarettes, cigars, pipe, snuff, or chewing tobacco) or smoking any non-tobacco related products and urine cotinine (less than 100 ng/mL
- Does not currently smoke but has quit smoking for more than 10 years and smoked less than 1 pack/day of cigarettes when they were actively smoking and has a urine cotinine (less than 100 ng/mL).
- Smoker
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- Smokes habitually at least 10 cigarettes/day and a urine cotinine level of >1000 ng/mL. Cigar and pipe smokers who smoke at least 10 grams of tobacco daily are also eligible.
- Agree to consume a standardized vitamin and mineral supplement and avoid other nutritional, dietary, or alternative medications/supplements for the duration of the study.
- No history of malabsorptive, gastrointestinal or other metabolic disorders requiring special diet recommendations.
- Body mass index (BMI) between 20 and 35 kg/m2
- Abstain from purple and red colored foods and beverages which contain significant anthocyanins and polyphenols
- Abstain from the use of ANY mouth washes (commercial or home remedies)during 6 week study period
Who cannot join
- Have a known allergy to strawberries, corn, and wheat products or those who have never consumed any of these products.
- Have active metabolic or digestive illnesses such as malabsorptive disorders (Crohn's, ileus, IBS), renal insufficiency, hepatic insufficiency, hyper- or hypothyroidism, cachexia, morbid obesity, or short bowel syndrome.
- Have a history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, ACTH, growth hormone, insulin) or other endocrine disorders requiring hormone administration.
- Have significant loss of gastrointestinal organs due to surgery, except for appendix.
- Have altered immunity such as chronic inflammatory disease, autoimmune disorders, cancer, anemia, hemophilia, and blood dyscrasias.
- Heavy alcohol consumers defined as >15 glasses/week (one glass = 1.5 oz. liquor, 5 oz. wine, or 12 oz. beer).
Show all 13Show fewer
- Antibiotic use in the last 6 months or on medications that will accelerate or decrease bowel motility.
- Are receiving or in need of dental treatment during the study period.
- Have noticeable open lesions, sores that have not healed for more than 3 months, have had any active oral lesions or maladies within the last month, or have a history of leukoplakia, tumors of the buccal cavity, throat, and lips.
- Have difficulty swallowing (dysphagia), pain with swallowing (odynophagia), salivary gland dysfunction, or xerostomia (dry mouth).
- A "non-smoker" who is currently or has a history (less than 10 years of smoking abstinence) of either tobacco or non-tobacco related smoking.
- Women, who are planning to conceive in the next 6 months, suspect they are pregnant, pregnant, or nursing.
- Are taking medications that inhibit clotting (warfarin sodium) or using prescribed oral rinses (Peridex).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Phase I Study of the Use of Functional Confections in Promoting Oral Health in Men and Women
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.
Read the detailed description
Polyphenols (plant chemicals, some produce purple and red color in fruits) found in strawberries have been associated with reducing the risk of gum disease. However, much of these chemicals are susceptible to degradation during food processing and digestion. Minimally degraded in the mouth, polyphenols when consumed as fresh fruits are retained only for brief periods. Therefore, exposure of fresh fruit polyphenols to oral tissues may not be adequate for a biologic effect to occur. At OSU, food scientists have developed a 6 gram strawberry gummy containing 3 grams of freeze-dried strawberries designed to dissolve relatively slow in the mouth.
The investigators will investigate the effects of strawberry gummy consumption on oral health in 36 habitually smoking and non-smoking healthy adults (men and women). At the enrollment visit (Day-14), subjects will visit the OSU Clinical Research Center (CRC) for an oral brushing; submit a 24-hour urine collection, and a saliva sample. Subjects will then start an anthocyanin-free (avoid purple and red fruits and vegetables) diet which they will maintain for 6 weeks of this study. After 2 weeks, subjects will have their first "washout" visit at the CRC. This visit will be one of two "washout visits" where subjects will again submit samples (fasting blood, urine, saliva, and oral brushing). At this visit, smokers will be block randomized (random assignment using computer software) into one of two groups (strawberry or placebo gummies) with a matching non-smoker having the same gender and age group. A salivary pharmacokinetic (sPK) study will follow and involves collection of saliva at these time points: 5 minutes before gummy placed in the mouth, and at 5,10,15,20,25, and 30 minutes after gummies have been in the mouth. Subjects will be instructed to consume 2 pieces of strawberry, or placebo gummy 4 times a day for 7 days. After 7 days subjects return to the CRC for a "treatment visit" to submit fasting blood, urine, saliva and oral brushing samples. Subjects will repeat the two-week anthocyanin-free diet and return to the CRC for another "washout visit" before crossing over to the other study gummy. After 7 days of gummy consumption, subjects will return for their second treatment visit and submit fasting blood, oral brushing, saliva, and 24 hour urine collection.
- Conditions
- Oral Health, Oral Cancer, Gum Disease
- Being tested
- Strawberry gummy, Placebo control gummy
- Keywords
- Functional food, Strawberries, Gummies, Smoker, Nonsmoker
- Medical subject headings
- Mouth Neoplasms, Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strawberry gummyOther
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.
Placebo control gummyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo gummy | Placebo comparator | Each 6 gram placebo gummy contains 79% corn syrup (Karo, ACH Food Companies, Memphis, TN), 20% wheat starch (Confectioners G, Tate and Lyle PLC., Decatur, IL), 1% artificial strawberry flavors (Kool-Aid Kraft Foods, East Hanover, NJ). Receives: Other: Placebo control gummy |
| Strawberry gummy | Active comparator | Each 6 gram strawberry gummy contains 45% freeze-dried fruit (California Strawberry Commission), 44% corn syrup (Karo, ACH Food Companies, Memphis, TN), 11% wheat starch (Confectioners G, Tate and Lyle PLC., Decatur, IL). With this formulation, daily fruit consumption is equivalent to 1 cup of whole strawberries. All ingredients (wheat starch, freeze-dried fruit, and high fructose corn syrup) will be purchased from a single lot. When a single lot is not available then the multiple manufacturing lots will be mixed into a single lot to be used for production of fruit gummies. Receives: Other: Strawberry gummy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieve excellent compliance and minimal toxicity with consumption of the strawberry gummies.
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
Measured: one week after intervention
Secondary outcomes (2)
Quantify the enteral absorption and excretion patterns of strawberry polyphenols in smoking and non-smoking healthy adult men and women consuming the strawberry and placebo gummies.
This data will be used to define relationships between dietary intake, polyphenol metabolism and the biological outcomes examined in tertiary outcome.
- Pharmacokinetics of strawberry polyphenols in saliva following consumption of a single dose delivering two 6 gram fruit gummies will be compared in smoking and non-smoking men and women consuming the strawberry or placebo gummies.
- Prevalent strawberry polyphenols and their metabolites in saliva, serum, and urine will be assessed and compared with strawberry gummy type consumed.
Measured: Day 0, 7, 21, and 28
Measure salivary inflammatory markers and gene expression profiles in oral mucosa that promote oral health following short-term exposure to strawberry fruit polyphenol.
- Salivary inflammatory markers (cortisol, Ig A, and 8-hydroxydeoxyguanosine) following consumption of strawberry and placebo gummies will be compared in smoking and non-smoking men and women.
- Expression profiling will be examined on RNA obtained from longitudinal buccal brushings and plasma utilizing qRT-PCR and SuperArray's RT2 Profiler™ PCR Array (Inflammation Panel) containing 84 genes unique to the inflammation pathway and compared with strawberry gummy type consumed.
Measured: Day 0, 7, 21, 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startNov 2010
- Primary completion10 Apr 2026 (estimated)
- Study completion10 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yael Vodovotz, Ohio State University
- Investigators
- Yael Vodovotz, PhD., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514552
- Sponsor's protocol ID
- 2010H0073
- Status last verified
- Oct 2025
- First submitted
- 17 Jan 2012
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Phase I Study of the Use of Functional Confections in Promoting Oral Health in Men and Women
- ClinicalTrials.gov ID
- NCT01514552
- Acronym / sponsor ID
- 2010H0073
- Conditions
- Oral Health, Oral Cancer, Gum Disease
- Keywords
- Functional food, Strawberries, Gummies, Smoker, Nonsmoker
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- 10 Apr 2026 (estimated)
- Study completion
- 10 Apr 2026 (estimated)
- First posted
- 23 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Polyphenols (plant chemicals, some produce purple and red color in fruits) found in strawberries have been associated with reducing the risk of gum disease. However, much of these chemicals are susceptible to degradation during food processing and digestion. Minimally degraded in the mouth, polyphenols when consumed as fresh fruits are retained only for brief periods. Therefore, exposure of fresh fruit polyphenols to oral tissues may not be adequate for a biologic effect to occur. At OSU, food scientists have developed a 6 gram strawberry gummy containing 3 grams of freeze-dried strawberries designed to dissolve relatively slow in the mouth.
The investigators will investigate the effects of strawberry gummy consumption on oral health in 36 habitually smoking and non-smoking healthy adults (men and women). At the enrollment visit (Day-14), subjects will visit the OSU Clinical Research Center (CRC) for an oral brushing; submit a 24-hour urine collection, and a saliva sample. Subjects will then start an anthocyanin-free (avoid purple and red fruits and vegetables) diet which they will maintain for 6 weeks of this study. After 2 weeks, subjects will have their first "washout" visit at the CRC. This visit will be one of two "washout visits" where subjects will again submit samples (fasting blood, urine, saliva, and oral brushing). At this visit, smokers will be block randomized (random assignment using computer software) into one of two groups (strawberry or placebo gummies) with a matching non-smoker having the same gender and age group. A salivary pharmacokinetic (sPK) study will follow and involves collection of saliva at these time points: 5 minutes before gummy placed in the mouth, and at 5,10,15,20,25, and 30 minutes after gummies have been in the mouth. Subjects will be instructed to consume 2 pieces of strawberry, or placebo gummy 4 times a day for 7 days. After 7 days subjects return to the CRC for a "treatment visit" to submit fasting blood, urine, saliva and oral brushing samples. Subjects will repeat the two-week anthocyanin-free diet and return to the CRC for another "washout visit" before crossing over to the other study gummy. After 7 days of gummy consumption, subjects will return for their second treatment visit and submit fasting blood, oral brushing, saliva, and 24 hour urine collection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo gummy | Placebo comparator | Other: Placebo control gummyEach 6 gram placebo gummy contains 79% corn syrup (Karo, ACH Food Companies, Memphis, TN), 20% wheat starch (Confectioners G, Tate and Lyle PLC., Decatur, IL), 1% artificial strawberry flavors (Kool-Aid Kraft Foods, East Hanover, NJ). |
| Strawberry gummy | Active comparator | Other: Strawberry gummyEach 6 gram strawberry gummy contains 45% freeze-dried fruit (California Strawberry Commission), 44% corn syrup (Karo, ACH Food Companies, Memphis, TN), 11% wheat starch (Confectioners G, Tate and Lyle PLC., Decatur, IL). With this formulation, daily fruit consumption is equivalent to 1 cup of whole strawberries. All ingredients (wheat starch, freeze-dried fruit, and high fructose corn syrup) will be purchased from a single lot. When a single lot is not available then the multiple manufacturing lots will be mixed into a single lot to be used for production of fruit gummies. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Submit to a 24 hour urine cotinine test which will be used to determine smoking status.
- Meet one of the following smoking criteria
- Non-smoker
- Does not currently smoke or has no history of smoking or using tobacco related products (cigarettes, cigars, pipe, snuff, or chewing tobacco) or smoking any non-tobacco related products and urine cotinine (less than 100 ng/mL
- Does not currently smoke but has quit smoking for more than 10 years and smoked less than 1 pack/day of cigarettes when they were actively smoking and has a urine cotinine (less than 100 ng/mL).
Key exclusion criteria (13 listed)
- Have a known allergy to strawberries, corn, and wheat products or those who have never consumed any of these products.
- Have active metabolic or digestive illnesses such as malabsorptive disorders (Crohn's, ileus, IBS), renal insufficiency, hepatic insufficiency, hyper- or hypothyroidism, cachexia, morbid obesity, or short bowel syndrome.
- Have a history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, ACTH, growth hormone, insulin) or other endocrine disorders requiring hormone administration.
- Have significant loss of gastrointestinal organs due to surgery, except for appendix.
- Have altered immunity such as chronic inflammatory disease, autoimmune disorders, cancer, anemia, hemophilia, and blood dyscrasias.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strawberry gummyRandomized 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 | Strawberry gummy |
| Placebo control gummyRandomized 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. | Other | Placebo gummy |
Primary outcome
Achieve excellent compliance and minimal toxicity with consumption of the strawberry gummies.
Time frame: one week after intervention
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
2 secondary outcomes
Quantify the enteral absorption and excretion patterns of strawberry polyphenols in smoking and non-smoking healthy adult men and women consuming the strawberry and placebo gummies.
Time frame: Day 0, 7, 21, and 28
Measure salivary inflammatory markers and gene expression profiles in oral mucosa that promote oral health following short-term exposure to strawberry fruit polyphenol.
Time frame: Day 0, 7, 21, 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yael Vodovotz, PhD. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Strawberry gummy in people with Oral Health and Oral Cancer, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achieve excellent compliance and minimal toxicity with consumption of the strawberry gummies. (time frame: one week after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.