The Use of Functional Confections in Promoting Oral Health

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Brief Title

The Use of Functional Confections in Promoting Oral Health

Official Title

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

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.
    

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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Achieve excellent compliance and minimal toxicity with consumption of the strawberry gummies.

Secondary Outcome

 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.

Condition

Oral Health

Intervention

Strawberry gummy

Study Arms / Comparison Groups

 Placebo gummy
Description:  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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

36

Start Date

November 2010

Completion Date

December 2021

Primary Completion Date

December 2020

Eligibility 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).
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Yael Vodovotz, PhD., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01514552

Organization ID

2010H0073


Responsible Party

Principal Investigator

Study Sponsor

Ohio State University


Study Sponsor

Yael Vodovotz, PhD., Principal Investigator, Ohio State University


Verification Date

September 2019