Clinical trial · Interventional
Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers
Phytochemical Release Rate From Black Raspberry Confections Alters Gene Expression and Chemical Profiles Relevant to Inhibition of Oral Carcinogenesis
NCT01961869CI-TRIAL-00114679completedPhase 1ClinicalTrials.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)
This clinical trial studies black raspberry confection in preventing oral cancer in healthy volunteers. Black raspberry contains ingredients that may prevent or slow the growth of certain cancers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy Volunteers | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fast release BRB confection | Other | — | UNRESOLVED |
| Intermed release BRB confection | Other | — | UNRESOLVED |
| Prolong release BRB confection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Arm I (Fast release BRB confection 4g)
- description
- Participants receive one fast release BRB confection (4g) PO 4-6 hours apart thrice daily (TID) for 2 weeks.
- interventionNames
- Other: Fast release BRB confection
- type
- EXPERIMENTAL
- label
- Arm II (Fast release BRB confection 8g)
- description
- Participants receive two fast release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
- interventionNames
- Other: Fast release BRB confection
- type
- EXPERIMENTAL
- label
- Arm III (Intermed release BRBconfection 4g)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Be healthy, free-living adults * Be a non-smoker (defined as adults who have never smoked or who have not had a cigarette in the past ten years) * Agree to consume a standardized vitamin/mineral supplement and avoid other nutrition and alternative supplements for the duration of the study * Agree to follow a berry-restricted diet and to document any accidental consumption of restricted foods each day of the study * Agree to abstain from mouthwashes Exclusion Criteria: * Have an active metabolic or digestive illness including malabsorptive disorders, renal insufficiency, hepatic insufficiency, cachexia, or short bowel syndrome * Have an active or a recent history of any condition that causes altered immunity such as chronic inflammatory disease, autoimmune disorders, cancer, anemia, and blood dyscrasias * Have a known allergy or food intolerance to ingredients in study products (black raspberries),other berries, wheat, or soy * Are strict vegans (no consumption of animal, fish or egg products) * Are planning to conceive, or are currently pregnant or lactating * Are heavy alcohol consumers (defined as an average consumption of greater than 2 drinks/day) * Have a history of oral cancer or currently undergoing treatment of oral cancer * In the last month have had any active oral lesions or maladies or currently have any oral disease or obvious open sores in the oral cavity or surrounding the oral opening * Have strong gag reflex or problems swallowing that prohibit buccal brushing of the oral cavity * Have been on an antibiotic regime lasting for one week in the last 6 months
References
Publications (0)
Data not yet available
No reference posted for this study.