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Raspberry

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

Each lozenge is made from 1 gram of freeze-dried black raspberry powder (equivalent to \~5 black raspberries) in the form of a dissolvable slow-release lozenge.

BRB Lozenges

Karam El-Bayoumy, Ph.D

Nicolle Krebs, MS

Charity Sauder

Karam P El-Bayoumy, Ph.D

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.

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.

Prevention of Oral DNA Damage by Black Raspberries

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

Marker of DNA damage caused by tobacco specific nitrosamines in tobacco smoke

Marker of DNA damage caused by benzo\[a\]pyrene in tobacco smoke

Biomarker of oxidative damage to DNA caused by tobacco smoke

Biomarker of exposure to the black raspberry chemopreventive anthocyanins

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Prevention of Oral DNA Damage by Black Raspberries	NCT04372914	Oral Cancer Smoking DNA Damage Oxidative Stres...	BRB Lozenges	21 Years - 75 Years	Milton S. Hershey Medical Center
Prevention of Oral DNA Damage by Black Raspberries	NCT04372914	Oral Cancer Smoking DNA Damage Oxidative Stres...	BRB Lozenges	21 Years - 75 Years	Milton S. Hershey Medical Center

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