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
October 7, 2021
Completion Date
September 2024
Primary Completion Date
September 2024
Eligibility Criteria
Inclusion Criteria:
- Age 21-75
- Smoke 5 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 - 75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
John P Richie, Ph.D, 7175317178, [email protected]
Location Countries
United States
Location Countries
United States
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
November 2022