Status:
ACTIVE_NOT_RECRUITING
The Use of Functional Confections in Promoting Oral Health
Lead Sponsor:
Ohio State University
Conditions:
Oral Health
Oral Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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 ora...
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 suscep...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 10 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01514552
Start Date
November 1 2010
End Date
April 10 2026
Last Update
October 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Ohio State University
Columbus, Ohio, United States, 43220