Black Raspberry Confection for Healthy Subjects

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Metabolic illness, Altered immunity, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

67 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Black Raspberry Confection?

Research suggests that black raspberries may help reduce inflammation after eating a high-fat meal, as seen in a study with older overweight males. Additionally, black raspberry products have been developed for cancer prevention, showing good retention of beneficial compounds like anthocyanins, which are known for their health benefits. ^{1 2 3 4 5}

Is Black Raspberry Confection safe for humans?

Black Raspberry Confections have been used in human clinical trials for cancer prevention and were well accepted in sensory tests, suggesting they are generally safe for human consumption. ^{1 6 7 8 9}

How is the Black Raspberry Confection treatment unique?

The Black Raspberry Confection is unique because it is designed to deliver high levels of phytochemicals, like anthocyanins and ellagitannins, which are known for their potential cancer-preventive properties. Unlike other treatments, this confection provides a controlled release of these compounds, making it a novel approach for oral disease prevention and potentially reducing cancer risk. ^{1 6 9 10 11}

What is the purpose of this trial?

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.

Research Team

Yael Vodovotz, Ph.D.

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

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

I agree to follow the study's vitamin/mineral plan and not take other supplements.

Exclusion Criteria

I have had or am currently being treated for oral cancer.

I have a condition that affects my immune system, like autoimmune disease or cancer.

I have not had any mouth sores or oral diseases in the last month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive black raspberry confections with varying release rates and doses for 2 weeks

2 weeks

Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

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.

Participant Groups

Group I: Arm VI (Prolong release BRB confection 8g) Experimental Treatment 1 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 Treatment 1 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 Treatment 1 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 Treatment 1 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 Treatment 1 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 Treatment 1 Intervention

Participants receive one fast release BRB confection (4g) PO 4-6 hours apart thrice daily (TID) for 2 weeks.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Characterization of black raspberry functional food products for cancer prevention human clinical trials. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Polyphenol-rich extract from blackcurrant pomace attenuates the intestinal tract and serum lipid changes induced by a high-fat diet in rabbits. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

An Open-Label Randomized Crossover Trial of Lyophilized Black Raspberries on Postprandial Inflammation in Older Overweight Males: A Pilot Study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Fresh raspberry phytochemical extract inhibits hepatic lesion in a Wistar rat model. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Fortification with Raspberry Juice on the Antioxidant and Potentially Anti-Inflammatory Activity of Wafers Subjected to In Vitro Digestion. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Development and characterization of different black raspberry confection matrices designed for delivery of phytochemicals. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Marketplace analysis demonstrates quality control standards needed for black raspberry dietary supplements. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Dose-Dependent Increases in Ellagitannin Metabolites as Biomarkers of Intake in Humans Consuming Standardized Black Raspberry Food Products Designed for Clinical Trials. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Black raspberries in cancer clinical trials: Past, present and future. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the jelly processing potential of raspberries adapted in Brazil. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Rubus occidentalis: The black raspberry--its potential in the prevention of cancer. [2016]