Black Raspberry Confection for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether black raspberry confections can help prevent oral cancer. Participants will take varying amounts of these confections over two weeks. Researchers aim to determine if the confections can stop or slow cancer growth. Ideal participants are healthy adults who do not smoke and are willing to follow specific dietary restrictions, such as avoiding other nutritional supplements and berries. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, you must avoid other nutrition and alternative supplements during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that black raspberry treats, like those in this study, are made from ingredients generally considered safe, including freeze-dried black raspberry powder, corn syrup, and sugar. These ingredients are common in foods and have a strong safety record.
Previous studies have used similar black raspberry treats in cancer prevention trials. Participants in those studies usually tolerated the treats well, with no major side effects reported. However, some individuals have experienced minor skin irritation or allergic reactions to black raspberry products in general.
Overall, the black raspberry treats studied so far appear to be well-tolerated by most people. While each new trial provides more information, current evidence suggests these treats are safe for use.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the black raspberry (BRB) confection because it uses a natural ingredient known for its antioxidant properties, which might offer a more holistic approach compared to conventional treatments. Unlike standard options that often involve synthetic compounds, this treatment utilizes black raspberries, potentially reducing side effects and enhancing patient safety. Additionally, the trial explores different release formulations—fast, intermediate, and prolonged—providing insights into how the timing of release affects efficacy, which is a novel approach in this area. Each formulation offers a unique delivery method, potentially optimizing how the body absorbs and utilizes the active compounds for maximum benefit.
What evidence suggests that this trial's treatments could be effective in preventing oral cancer?
Research shows that black raspberries (BRB) might slow the growth of various cancers. Studies have found that BRB retains over 90% of key substances like anthocyanins and ellagitannins, known for their cancer-fighting properties. In early animal research, BRB proved effective against cancers of the mouth, esophagus, and others. The black raspberry confection tested in this trial is designed to release these beneficial substances at different rates in the body. Although this trial involves healthy participants, earlier research suggests it might help prevent cancer.678910
Who Is on the Research Team?
Yael Vodovotz, Ph.D.
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive black raspberry confections with varying release rates and doses for 2 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Black Raspberry Confection
Trial Overview
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.
How Is the Trial Designed?
Participants receive two prolonged release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
Participants receive one prolonged release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks.
Participants receive two intermediate release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
Participants receive one intermediate release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks.
Participants receive two fast release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
Participants receive one fast release BRB confection (4g) PO 4-6 hours apart thrice daily (TID) for 2 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor
Citations
Black Raspberry Confection in Preventing Oral Cancer ...
Participants receive one fast release BRB confection (4g) PO 4-6 hours apart thrice daily (TID) for 2 weeks. Other Names: black raspberry confection. BRB ...
Characterization of Black Raspberry Functional Food ...
Confections retained >90% of anthocyanins and ellagitannin after processing. Nectars had >69% of anthocyanins and >66% of ellagitannin retention, which varied ...
Black Raspberry Confection for Healthy Subjects
This clinical trial studies black raspberry confection in preventing oral cancer in healthy volunteers. Black raspberry contains ingredients that may prevent or ...
Development and Characterization of Different Black ...
In the results, BRB content reached 22% in hard candy and pectin-based confections and 40% in starch-based confections, respectively. Pectin- ...
Development and characterization of different black ...
In the results, BRB content reached 22% in hard candy and pectin-based confections and 40% in starch-based confections, respectively. Pectin- and starch-based ...
Black Raspberry Confection in Preventing Oral Cancer ...
Fast release BRB confection includes lyophilized black raspberry powder, corn syrup, and sugar. All ingredients are generally regarded as safe (GRAS) food ...
Development and Characterization of Different Black ...
Three forms of confections containing black raspberries (BRB) powder were developed to provide controlled release of phytochemicals for oral ...
Safety Data Sheet Black Raspberry Fragrance
Most Important Symptoms. Causes skin irritation. Acute and Delated: May cause an allergic skin reaction. Causes serious eye irritation.
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researchgate.net
researchgate.net/publication/272186674_Development_and_Characterization_of_Different_Black_Raspberry_Confection_Matrices_Designed_for_Delivery_of_Phytochemicals(PDF) Development and Characterization of Different Black ...
PDF | Three forms of confections containing black raspberries (BRB) powder were developed to provide controlled release of phytochemicals ...
Chemoprevention of Oral Cancer by Topical Application ...
Epidemiologic data consistently associates increased fruit consumption with decreased oral cancer risk. Black raspberries (BRBs) are rich in bioactive ...
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