NCT01961869

Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers

Phytochemical Release Rate From Black Raspberry Confections Alters Gene Expression and Chemical Profiles Relevant to Inhibition of Oral Carcinogenesis

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: 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

• Healthy Volunteers

Interventions

Type	Name	Description
OTHER	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
OTHER	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
OTHER	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.

Timeline

• Start date: 2013-07-02
• Primary completion: 2014-05-14
• Completion: 2026-04-10
• First posted: 2013-10-14
• Last updated: 2025-11-20

Locations

1 site across 1 country: United States