Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers
NCT ID: NCT01961869
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
67 participants
INTERVENTIONAL
2013-07-02
2026-04-10
Brief Summary
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Detailed Description
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I. To select an optimal black raspberry confection based on altered gene expression and chemical profiles in healthy individuals exposed to 3 black raspberry-based amorphous functional confections with modulated bioactive release rate at two doses (4 g and 8 g).
OUTLINE: Participants are randomized to 1 of 6 arms after 2 weeks.
ARM I: Participants receive black raspberry (BRB) confection 1 fast release orally (PO) 4-6 hours apart thrice daily (TID) for 2 weeks.
ARM II: Participants receive BRB confection 2 fast release PO 4-6 hours apart TID for 2 weeks.
ARM III: Participants receive BRB confection 1 intermediate release PO 4-6 hours apart TID for 2 weeks.
ARM IV: Participants receive BRB confection 2 intermediate release PO 4-6 hours apart TID for 2 weeks.
ARM V: Participants receive BRB confection 1 prolonged release PO 4-6 hours apart TID for 2 weeks.
ARM VI: Participants receive BRB confection 2 prolonged release PO 4-6 hours apart TID for 2 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Arm I (Fast release BRB confection 4g)
Participants receive one fast release BRB confection (4g) PO 4-6 hours apart thrice daily (TID) for 2 weeks.
Fast release BRB confection
Fast release BRB confection includes lyophilized black raspberry powder, corn syrup, and sugar. All ingredients are generally regarded as safe (GRAS) food ingredients
Arm II (Fast release BRB confection 8g)
Participants receive two fast release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
Fast release BRB confection
Fast release BRB confection includes lyophilized black raspberry powder, corn syrup, and sugar. All ingredients are generally regarded as safe (GRAS) food ingredients
Arm III (Intermed release BRBconfection 4g)
Participants receive one intermediate release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks.
Intermed release BRB confection
Intermediate release BRB confection includes lyophilized black raspberry powder, corn syrup, sugar, and pectin. All ingredients are generally regarded as safe (GRAS) food ingredients
Arm IV (Intermed release BRBconfection 8g)
Participants receive two intermediate release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
Intermed release BRB confection
Intermediate release BRB confection includes lyophilized black raspberry powder, corn syrup, sugar, and pectin. All ingredients are generally regarded as safe (GRAS) food ingredients
Arm V (Prolong release BRB confection 4g)
Participants receive one prolonged release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks.
Prolong release BRB confection
Prolonged release BRB confection includes lyophilized black raspberry powder, corn syrup, corn starch, and sugar. All ingredients are generally regarded as safe (GRAS) food ingredients.
Arm VI (Prolong release BRB confection 8g)
Participants receive two prolonged release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
Prolong release BRB confection
Prolonged release BRB confection includes lyophilized black raspberry powder, corn syrup, corn starch, and sugar. All ingredients are generally regarded as safe (GRAS) food ingredients.
Interventions
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Fast release BRB confection
Fast release BRB confection includes lyophilized black raspberry powder, corn syrup, and sugar. All ingredients are generally regarded as safe (GRAS) food ingredients
Intermed release BRB confection
Intermediate release BRB confection includes lyophilized black raspberry powder, corn syrup, sugar, and pectin. All ingredients are generally regarded as safe (GRAS) food ingredients
Prolong release BRB confection
Prolonged release BRB confection includes lyophilized black raspberry powder, corn syrup, corn starch, and sugar. All ingredients are generally regarded as safe (GRAS) food ingredients.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
Yes
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Yael Vodovotz
Principal Investigator
Principal Investigators
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Yael Vodovotz, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States
Countries
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Related Links
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The Jamesline
Other Identifiers
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NCI-2013-01724
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-13052
Identifier Type: -
Identifier Source: org_study_id
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