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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 14

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 14

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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.

0 / 3Eligibility criteria met

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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

320 Previous Clinical Trials

290,100 Total Patients Enrolled

Yael Vodovotz, Ph.D.Principal InvestigatorOhio State University Comprehensive Cancer Center

1 Previous Clinical Trials

20 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility limited to individuals 85 years or younger for this experiment?

"This medical experiment is open to participants aged 18 and beyond, but younger than 65."

Answered by AI

Has Fast release BRB confection obtained regulatory authority approval?

"Limited evidence exists for Fast Release BRB Confection's safety and efficacy, thus our team assessed the drug to be a 1 on their rating scale."

Answered by AI

Would I be eligible to participate in this research initiative?

"In order to be eligible for this clinical experiment, candidates must have healthy subjects (HS) and fit within the 18-65 year old age bracket. The total number of participants admitted into the trial is 67 individuals."

Answered by AI

Are there any vacancies left in this clinical research project?

"Clinicaltrials.gov indicates that the study, which was initially posted on July 2nd 2013 and last updated November 4th 2022, is not currently admitting participants. Nevertheless, 839 other studies are welcoming candidates at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers

Yael Vodovotz 2013. "Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01961869.

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