A Pilot Phase I Study of the Use of Functional Confections in Promoting Oral Health in Men and Women
18 Years
70 Years
Both
Oral Health, Oral Cancer, Gum Disease
Trial Information
A Pilot Phase I Study of the Use of Functional Confections in Promoting Oral Health in Men and Women
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.
Inclusion Criteria:
- 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
- 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
Exclusion Criteria
- 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).
- 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).
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Outcome Measure:
Achieve excellent compliance and minimal toxicity with consumption of the strawberry gummies.
Outcome Description:
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
Outcome Time Frame:
one week after intervention
Safety Issue:
Yes
Principal Investigator
Yael Vodovotz, PhD.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ohio State University
Authority:
United States: Institutional Review Board
Study ID:
2010H0073
NCT ID:
NCT01514552
Start Date:
November 2010
Completion Date:
June 2014
Related Keywords:
- Oral Health
- Oral Cancer
- Gum Disease
- Functional food
- Strawberries
- Gummies
- Smoker
- Nonsmoker
- Gingival Diseases
- Periodontal Diseases
- Mouth Neoplasms
Name | Location |
|---|---|
| The Ohio State University | Columbus, Ohio 43210 |
