The Use of Functional Confections in Promoting Oral Health

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yael Vodovotz, Ohio State University
ClinicalTrials.gov Identifier:
NCT01514552
First received: January 17, 2012
Last updated: July 19, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Oral Health
Oral Cancer
Gum Disease
Other: Strawberry gummy
Other: Placebo control gummy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Pilot Phase I Study of the Use of Functional Confections in Promoting Oral Health in Men and Women

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Achieve excellent compliance and minimal toxicity with consumption of the strawberry gummies. [ Time Frame: one week after intervention ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • 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. [ Time Frame: Day 0, 7, 21, and 28 ] [ Designated as safety issue: No ]

    This data will be used to define relationships between dietary intake, polyphenol metabolism and the biological outcomes examined in tertiary outcome.

    1. Pharmacokinetics of strawberry polyphenols in saliva following consumption of a single dose delivering two 6 gram fruit gummies will be compared in smoking and non-smoking men and women consuming the strawberry or placebo gummies.
    2. Prevalent strawberry polyphenols and their metabolites in saliva, serum, and urine will be assessed and compared with strawberry gummy type consumed.

  • Measure salivary inflammatory markers and gene expression profiles in oral mucosa that promote oral health following short-term exposure to strawberry fruit polyphenol. [ Time Frame: Day 0, 7, 21, 28 ] [ Designated as safety issue: No ]
    1. Salivary inflammatory markers (cortisol, Ig A, and 8-hydroxydeoxyguanosine) following consumption of strawberry and placebo gummies will be compared in smoking and non-smoking men and women.
    2. Expression profiling will be examined on RNA obtained from longitudinal buccal brushings and plasma utilizing qRT-PCR and SuperArray's RT2 Profiler™ PCR Array (Inflammation Panel) containing 84 genes unique to the inflammation pathway and compared with strawberry gummy type consumed.


Estimated Enrollment: 36
Study Start Date: November 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo gummy
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
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.
Active Comparator: Strawberry gummy
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
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.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514552

Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43220
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Yael Vodovotz, PhD. Ohio State University
  More Information

No publications provided

Responsible Party: Yael Vodovotz, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01514552     History of Changes
Other Study ID Numbers: 2010H0073
Study First Received: January 17, 2012
Last Updated: July 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Functional food
Strawberries
Gummies
Smoker
Nonsmoker

Additional relevant MeSH terms:
Gingival Diseases
Periodontal Diseases
Mouth Neoplasms
Mouth Diseases
Stomatognathic Diseases
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014