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ACTIVE NOT RECRUITING

NCT01514552

PHASE1

The Use of Functional Confections in Promoting Oral Health

Sponsor: Ohio State University

View on ClinicalTrials.gov

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. 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.

Official title: A Pilot Phase I Study of the Use of Functional Confections in Promoting Oral Health in Men and Women

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2010-11

Completion Date

2026-04-10

Last Updated

2025-10-20

Healthy Volunteers

Yes

Conditions

Oral Health Oral Cancer Gum Disease

Interventions

OTHER

Strawberry gummy

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.

OTHER

Placebo control gummy

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.

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).

Locations (1)

The Ohio State University

Columbus, Ohio, United States