The Use of Functional Confections in Promoting Oral Health

NCT01514552 | Active Not Recruiting Phase 1

• 1 other identifier: 2010H0073
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Oral Health; Oral Cancer; Gum Disease

Keywords

Functional food; Strawberries; Gummies; Smoker; Nonsmoker

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Quantify the enteral absorption and excretion patterns of strawberry polyphenols in smoking and non-smoking healthy adult men and women consuming the strawberry and placebo gummies.

  Day 0, 7, 21, and 28

• Measure salivary inflammatory markers and gene expression profiles in oral mucosa that promote oral health following short-term exposure to strawberry fruit polyphenol.

  Day 0, 7, 21, 28

Study Arms (2)

Placebo gummy

PLACEBO COMPARATOR

Each 6 gram placebo gummy contains 79% corn syrup (Karo, ACH Food Companies, Memphis, TN), 20% wheat starch (Confectioners G, Tate and Lyle PLC., Decatur, IL), 1% artificial strawberry flavors (Kool-Aid Kraft Foods, East Hanover, NJ).

Other: Placebo control gummy

Strawberry gummy

ACTIVE COMPARATOR

Each 6 gram strawberry gummy contains 45% freeze-dried fruit (California Strawberry Commission), 44% corn syrup (Karo, ACH Food Companies, Memphis, TN), 11% wheat starch (Confectioners G, Tate and Lyle PLC., Decatur, IL). With this formulation, daily fruit consumption is equivalent to 1 cup of whole strawberries. All ingredients (wheat starch, freeze-dried fruit, and high fructose corn syrup) will be purchased from a single lot. When a single lot is not available then the multiple manufacturing lots will be mixed into a single lot to be used for production of fruit gummies.

Other: Strawberry gummy

Interventions

Strawberry gummy OTHER

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.

Strawberry gummy

Placebo control gummy OTHER

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.

Placebo gummy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43220, United States

Location

MeSH Terms

Conditions

Mouth Neoplasms; Gingival Diseases

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Periodontal Diseases

Study Officials

• Yael Vodovotz, PhD.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: January 23, 2012
• Study Start: November 1, 2010
• Primary Completion: April 10, 2026
• Study Completion: April 10, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

US (1)