Use of Functional Confections in Promoting Oral Health
in Men and Women
HYPOTHESIS: A strawberry concentrate incorporated into a gummy-type confection will deliver bioactive phytochemicals to the oral mucosa, and these phytonutrients will induce expression of critical genes and proteins associated with key biological pathways that may foster good oral health. Data from this trial is crucial for planning future prevention trials for people at high risk for or who have early-stage oral cancer.
RATIONALE: LAn estimated 80 percent of the U.S. population is affected with gum disease, and 30,000 individuals are newly diagnosed with oral cancer annually. Studies indicate that diets high in fruit intake can reduce oral-cancer risk by 20 to 80 percent, an effect attributed to the many phytonutrients found in fruit. Phytonutrients in strawberries show particular promise in preventing oral disease, but these compounds are readily broken down by gastrointestinal microflora and eliminated with little systemic absorption.
A more effective and palatable system to deliver phytonutrients to the oral mucosa is needed. This six-week, phase I/II, placebo-controlled clinical trial for healthy smokers and non-smokers evaluates the topical application of phytochemicals using a strawberry gummy confection.
The trial investigates whether short-term administration of the strawberry concentrate will transfer measurable amounts of phytonutrients to oral tissues and modulate genes associated with oxidation and inflammation, without significant adverse affects. The study also investigates the effects of smoking on these parameters.
A total of 36 healthy men and women will be stratified into three age groups, with six active smokers and non-smokers in each group. Subjects will visit Ohio State's Clinical Research Center five times during the six-week period.
Ohio State's Department of Food Science and Technology developed the six-gram, gummy confection so that it can easily be cradled in the oral vestibule even by individuals with significant tooth loss, oral sores and other oral maladies. The gummies, prepared by Ohio State's Food Industries Center Gould Food Pilot Plant, contain 45 percent freeze-dried fruit. Used as directed, they deliver the equivalent of one cup of whole strawberries daily. Placebo gummies have no freeze-dried fruit.
The study has three main objectives:
• To measure compliance with consumption of the strawberry gummies.
• To quantify the absorption and excretion patterns of strawberry polyphenols in smoking and non-smoking participants.
• To determine if consumption of the strawberry gummy compared with placebo has a greater effect on salivary inflammatory markers and modulates the expression of genes that promote oral health following short-term exposure.
The benefits to the subject related to strawberry polyphenol bioavailability and oral health are unknown. Participants receive parking or bus vouchers to assist with their travel, and gift certificates to compensate for time and effort.
AT A GLANCE
Use of Functional Confections
in Promoting Oral Health in Men and Women
PI: YAEL VODOVOTZ, PHD, associate professor, Department of Food Science and Technology and a member of the Molecular Carcinogenesis and Chemoprevention Program
Eligibility:Age 18 to 70; Smoker or nonsmoker; Agree to a cotinine urine test to determine smoking status; Agree to consume a standardized vitamin and mineral supplement; No history of metabolic disorders; Body mass index between 18 and 30 kg/m2; Abstain from foods with significant anthocyanins and polyphenols; Agree to avoid all commercial and homemade mouthwashes.