Clinical trial · Interventional
Prevention of Oral DNA Damage by Black Raspberries
Effect of Oral Black Raspberry Administration on Oral Cell DNA Adducts in Smokers
NCT04372914CI-TRIAL-00103705completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DNA Damage | — | UNRESOLVED | — |
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oxidative Stress | — | UNRESOLVED | — |
| Smoking | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BRB Lozenges | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BRB Lozenges
- description
- Oral lozenges that contain 1 gram of BRB freeze-dried powder
- interventionNames
- Dietary Supplement: BRB Lozenges
Primary outcomes (1)
- measure
- HPB-releasing Adducts (Buccal Cells)
- timeFrame
- 8 weeks
- description
- 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).
Secondary outcomes (5)
- measure
- B[a]P Adducts (Buccal Cells)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.