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Cancer Preventive Agent

Black Raspberry Confection for Healthy Subjects

Phase 1
Waitlist Available
Led By Yael Vodovotz, Ph.D.
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Agree to consume a standardized vitamin/mineral supplement and avoid other nutrition and alternative supplements for the duration of the study
Be healthy, free-living adults
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 14
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if black raspberry can help prevent oral cancer in healthy people. Its ingredients may slow cancer growth.

Who is the study for?
This trial is for healthy adults who have never smoked or quit over ten years ago. Participants must not be pregnant, planning to conceive, or lactating, and should not have a history of oral cancer or certain immune conditions. They must avoid specific diets and supplements during the study.
What is being tested?
The trial is testing three types of black raspberry confections with different release times (fast, intermediate, prolonged) to see if they can prevent oral cancer by slowing down the growth of potential cancers.
What are the potential side effects?
Since this trial involves healthy volunteers consuming black raspberry confections, side effects are expected to be minimal but may include possible allergic reactions or intolerance to ingredients in the product.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to follow the study's vitamin/mineral plan and not take other supplements.
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I am a healthy adult living independently.
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I have not smoked cigarettes in the past ten years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had or am currently being treated for oral cancer.
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I have not had any mouth sores or oral diseases in the last month.
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I have a condition affecting my body's ability to process nutrients.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptance of candidate formulations, assessed using a 9 point hedonic scale (1 =dislike very much, 9 = like very much)
Bioavailability index, defined as the average rank of BRB effect in anthocyanins, ellagic acid, urolithins, and quercetin derivatives
Gene expression index, defined as the average rank of BRB effect on expression of genes responsive to BRBs and important to smoking and inflammatory response

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Group I: Arm VI (Prolong release BRB confection 8g)Experimental Treatment1 Intervention
Participants receive two prolonged release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
Group II: Arm V (Prolong release BRB confection 4g)Experimental Treatment1 Intervention
Participants receive one prolonged release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks.
Group III: Arm IV (Intermed release BRBconfection 8g)Experimental Treatment1 Intervention
Participants receive two intermediate release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
Group IV: Arm III (Intermed release BRBconfection 4g)Experimental Treatment1 Intervention
Participants receive one intermediate release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks.
Group V: Arm II (Fast release BRB confection 8g)Experimental Treatment1 Intervention
Participants receive two fast release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
Group VI: Arm I (Fast release BRB confection 4g)Experimental Treatment1 Intervention
Participants receive one fast release BRB confection (4g) PO 4-6 hours apart thrice daily (TID) for 2 weeks.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
340 Previous Clinical Trials
294,188 Total Patients Enrolled
Yael Vodovotz, Ph.D.Principal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
20 Total Patients Enrolled
~5 spots leftby Nov 2025
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