Spots Global Cancer Trial Database for Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers

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Trial Identification

Brief Title: Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers

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

Study ID: NCT01961869

Conditions

Healthy Volunteers

Interventions

Fast release BRB confection

Intermed release BRB confection

Prolong release BRB confection

Study Description

Brief 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.