Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Healthy Volunteers

Clinical Trial Details

NCT number	NCT01961869
Study type	Interventional
Source	Ohio State University Comprehensive Cancer Center
Contact
Status	Active, not recruiting
Phase	Phase 1
Start date	July 2, 2013
Completion date	July 10, 2024

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