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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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
one week after intervention
Yael Vodovotz, PhD.
Ohio State University
United States: Institutional Review Board
|The Ohio State University||Columbus, Ohio 43210|