Prevention of Oral DNA Damage by Black Raspberries

NCT04372914 | Completed Results DMC

• 2 other identifiers: STUDY00013621R01CA173465
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Cancer; Smoking; DNA Damage; Oxidative Stress

Outcome Measures

Primary Outcomes (1)

• HPB-releasing Adducts (Buccal Cells)

  The tobacco specific nitrosamine, N'-nitrosonornicotine, is metabolically activated to form DNA adduct that upon hydrolysis releases 4-hydroxy-1-(3-pyridyl)-1-butonone (HPB), which was measured in buccal cells of smokers in picogram per microgram guanine (one of the four bases of DNA).

  8 weeks

Secondary Outcomes (5)

• B[a]P Adducts (Buccal Cells)

  8 weeks

• 8-OXO-dG (Buccal Cells)

  8 weeks

• Cotinine (Urine)

  8 weeks

• Creatinine (Urine)

  8 weeks

• 8-Isoprostane (Urine)

  8 weeks

Study Arms (1)

BRB Lozenges

EXPERIMENTAL

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

Dietary Supplement: BRB Lozenges

Interventions

BRB Lozenges DIETARY_SUPPLEMENT

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

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Penn State CTSI Clinical Research Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Mouth Neoplasms; Smoking

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Behavior

Results Point of Contact

• Title: Karam El-Bayoumy
• Organization: Penn State College of Medicine

kelbayoumy@pennstatehealth.psu.edu

717 531 1005

Study Officials

• Karam P El-Bayoumy, Ph.D

  Penn State University Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director for Basic Research, Penn State Cancer Institute

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: May 4, 2020
• Study Start: October 7, 2021
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: February 20, 2026
• Results First Posted: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)