Trial Outcomes & Findings for Prevention of Oral DNA Damage by Black Raspberries (NCT NCT04372914)

Last Updated: 2026-02-20

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

69 participants

Primary outcome timeframe

8 weeks

Results posted on

2026-02-20

Participant Flow

Participant milestones

Participant milestones
Measure	BRB Lozenges Oral lozenges that contain 1 gram of BRB freeze-dried powder BRB Lozenges: 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.
Overall Study STARTED	69
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevention of Oral DNA Damage by Black Raspberries

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BRB Lozenges n=69 Participants Oral lozenges that contain 1 gram of BRB freeze-dried powder BRB Lozenges: 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.
Age, Continuous	47.2 years STANDARD_DEVIATION 11.3 • n=14 Participants
Sex: Female, Male Female	45 Participants n=14 Participants
Sex: Female, Male Male	24 Participants n=14 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=14 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	68 Participants n=14 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=14 Participants
Race (NIH/OMB) Asian	1 Participants n=14 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants
Race (NIH/OMB) Black or African American	2 Participants n=14 Participants
Race (NIH/OMB) White	63 Participants n=14 Participants
Race (NIH/OMB) More than one race	0 Participants n=14 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=14 Participants
Region of Enrollment United States	69 Participants n=14 Participants
Cigarettes per day	17.7 cigarettes per day STANDARD_DEVIATION 6.9 • n=14 Participants

PRIMARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome measures
Measure	BRB Lozenges n=40 Participants Oral lozenges that contain 1 gram of BRB freeze-dried powder BRB Lozenges: 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.
HPB-releasing Adducts (Buccal Cells)	0.67 picogram HPB/microgram guanine Standard Deviation 1.58

SECONDARY outcome

Timeframe: 8 weeks

Benzo\[a\]pyrene, a tobacco smoke constituent, is metabolized in buccal cells of smoker's into active metabolite namely benzo\[a\]pyrene-diol epoxide (BPDE). BPDE can react with DNA to form deoxyguanosine adducts (BPDE-N\^2-dG) that measured in buccal cells of smokers in picogram per microgram deoxyguanosine.

Outcome measures

Outcome measures
Measure	BRB Lozenges n=27 Participants Oral lozenges that contain 1 gram of BRB freeze-dried powder BRB Lozenges: 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.
B[a]P Adducts (Buccal Cells)	.31 picogram BPDE-N^2-dG/ microgram dG Standard Deviation .38

SECONDARY outcome

Timeframe: 8 weeks

Cigarette smoke is a rich source of free radicals that can promote oxidative stress and carcinogenesis, including head and neck squamous cell carcinoma. 8-oxo-7,8-dihydro-2'deoxyguanosine (8-oxo-dG) is a valid biomarker of oxidative stress. We measured 8-oxo-dG in buccal cells of smokers and the levels are expressed as picogram per microgram of deoxyguanosine.

Outcome measures

Outcome measures
Measure	BRB Lozenges n=21 Participants Oral lozenges that contain 1 gram of BRB freeze-dried powder BRB Lozenges: 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.
8-OXO-dG (Buccal Cells)	285.15 picogram 8-oxo-dG/ microgram dG Standard Deviation 116.60

SECONDARY outcome

Timeframe: 8 weeks

Biomarker of tobacco smoke exposure

Outcome measures

Outcome measures
Measure	BRB Lozenges n=40 Participants Oral lozenges that contain 1 gram of BRB freeze-dried powder BRB Lozenges: 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.
Cotinine (Urine)	6485.89 ng/ml Standard Deviation 4848.18

SECONDARY outcome

Timeframe: 8 weeks

Biomarker of urine dilution

Outcome measures

Outcome measures
Measure	BRB Lozenges n=40 Participants Oral lozenges that contain 1 gram of BRB freeze-dried powder BRB Lozenges: 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.
Creatinine (Urine)	1.39 mg/ml Standard Deviation 0.95

SECONDARY outcome

Timeframe: 8 weeks

Biomarker of systemic oxidative stress

Outcome measures

Outcome measures
Measure	BRB Lozenges n=21 Participants Oral lozenges that contain 1 gram of BRB freeze-dried powder BRB Lozenges: 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.
8-Isoprostane (Urine)	0.48 pmol/mg creatinine Standard Deviation 0.40

Adverse Events

BRB Lozenges

Serious events: 4 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BRB Lozenges n=69 participants at risk Oral lozenges that contain 1 gram of BRB freeze-dried powder BRB Lozenges: 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.
Infections and infestations Urinary tract infection	1.4% 1/69 • Number of events 1 • Adverse events were collected during the study period (13 weeks)
Infections and infestations Tooth infection	1.4% 1/69 • Number of events 1 • Adverse events were collected during the study period (13 weeks)
Cardiac disorders Hypertension	1.4% 1/69 • Number of events 1 • Adverse events were collected during the study period (13 weeks)
Nervous system disorders Tremors	1.4% 1/69 • Number of events 1 • Adverse events were collected during the study period (13 weeks)

Other adverse events

Other adverse events
Measure	BRB Lozenges n=69 participants at risk Oral lozenges that contain 1 gram of BRB freeze-dried powder BRB Lozenges: 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.
Musculoskeletal and connective tissue disorders Back pain	4.3% 3/69 • Number of events 3 • Adverse events were collected during the study period (13 weeks)
Infections and infestations Sinusitus	4.3% 3/69 • Number of events 3 • Adverse events were collected during the study period (13 weeks)
Gastrointestinal disorders Vomiting	4.3% 3/69 • Number of events 3 • Adverse events were collected during the study period (13 weeks)
Infections and infestations Flu like symptoms	5.8% 4/69 • Number of events 4 • Adverse events were collected during the study period (13 weeks)
Infections and infestations Upper respiratory infection	5.8% 4/69 • Number of events 5 • Adverse events were collected during the study period (13 weeks)

Additional Information

Karam El-Bayoumy

Penn State College of Medicine

Phone: 717 531 1005

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place