Prevention of Oral DNA Damage by Black Raspberries

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Brief Title

Prevention of Oral DNA Damage by Black Raspberries

Official Title

Effect of Oral Black Raspberry Administration on Oral Cell DNA Adducts in Smokers

Brief Summary

      The purpose of this voluntary research study is to learn about the potential effects that
      black raspberry (BRB) lozenges may have on reducing the damage caused from cigarette smoke in
      mouth cells in adult smokers, which may be useful in reducing health risks associated with
      smoking.
    

Detailed Description

      This clinical trial will consist of a single arm, where participants, after a 1-week baseline
      period, will be placed on daily BRB administration for a period of 8 weeks followed by a 4
      week washout period. Prior to study enrollment, all participants will have an Oral Cancer
      screening intraoral exam and persons with oral pathology (e.g. premalignant or oral squamous
      cell carcinoma) will be referred for appropriate clinical care. Biological samples will be
      collected at 0, 1, 4, 5, 8, 9, 12 and 13 weeks. An 8-week BRB administration period was
      selected to allow for ample time for effects to be observed in the major endpoints, based on
      previous clinical data. Likewise, a 4 week washout period at the end of the trial will allow
      for effects of BRB withdrawal on major outcomes to be measured.

      A total of 58 healthy subjects will be recruited into this intervention study. Eligible
      subjects, after phone screening, will visit the clinic for an additional in-person screening
      which includes measurement of expired carbon monoxide and pregnancy test (females). Prior to
      enrollment, each subject will be offered a free oral cancer screening. After obtaining
      informed consent, eligible subjects will be administered a questionnaire to obtain
      information on basic demographics, medical history, lifestyle, tobacco and alcohol
      consumption, and usual dietary intake and biological samples (exfoliated buccal cells and
      urine) and anthropometric data (e.g. height and weight) will be collected. Subjects will be
      asked to return after 1 week (Visit 2, 2nd baseline visit) and biological samples will be
      collected. Subjects will be provided their first supply of test agent (BRB lozenge) and a
      usage diary and instructed on the proper method for application and completion of the diary
      entries. At Visits 3-6 (weeks 4, 5, 8, and 9, respectively) subjects will return any unused
      product, receive a new batch of lozenges (except for week 9), complete a brief questionnaire
      on compliance and provide biological samples. At week 9 (Visit 6), subjects will return their
      study diaries and enter the washout period where no test agent will be provided. At the final
      visits (Visit 7 and 8, weeks 12 and 13), subjects will provide biological samples.
    


Study Type

Interventional


Primary Outcome

Change of HPB-releasing adducts (buccal cells) from Baseline to end of BRB lozenge treatment at 8 weeks

Secondary Outcome

 Change of B[a]P adducts (buccal cells) from Baseline to end of BRB lozenge treatment at 8 weeks

Condition

Oral Cancer

Intervention

BRB Lozenges

Study Arms / Comparison Groups

 BRB Lozenges
Description:  Oral lozenges that contain 1 gram of BRB freeze-dried powder

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

Dietary Supplement

Estimated Enrollment

58

Start Date

May 2021

Completion Date

December 2025

Primary Completion Date

May 2025

Eligibility Criteria

        Inclusion Criteria:

          -  Age 21-65

          -  Smoke 15 cigarettes per day or more for at least the past 12 months

          -  Have an expired air carbon monoxide measurement of greater than 6 parts per million

          -  No serious quit attempt in the last one month and not planning to quit in the next 4
             months

          -  Willing and able to attend all study visits

          -  Able to read and write in English

          -  Able to understand and provide consent to the study procedures

          -  Willingness and ability to attend regular visits over a 14-week period and to respond
             to research contacts between the 5

        Exclusion Criteria:

          -  Unstable or significant medical conditions that affect participant safety or biomarker
             data in the past 3 months (e.g. recent heart attack, asthma or COPD)

          -  Women currently pregnant or nursing

          -  Use of any non-cigarette nicotine delivery product in the past 7 days (e.g.
             e-cigarettes, pipe or cigar)

          -  Uncontrolled mental illness or inpatient treatment in the past 6 months; current
             suicide risk on clinical assessment

          -  Any known allergy to raspberries

          -  Use of marijuana or other illegal drugs daily or weekly in the past 3 months

          -  Use of high dose antioxidant supplements in the past month

          -  Use of antibiotics

          -  Heavy drinking (>4 drinks/day, 5 days/week)

          -  Made no serious cigarette smoking quit attempt or have used any FDA-approved smoking
             cessation medication in the prior 30 days

          -  No plan to quit smoking within the next 4 months
      

Gender

All

Ages

21 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

John P Richie, Ph.D, 7175317178, [email protected]



Administrative Informations


NCT ID

NCT04372914

Organization ID

STUDY00013621

Secondary IDs

R01CA173465

Responsible Party

Principal Investigator

Study Sponsor

Milton S. Hershey Medical Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

John P Richie, Ph.D, Principal Investigator, Penn State University Hershey Medical Center


Verification Date

March 2021