Broccoli Sprout Extracts in Healthy Volunteers: A Pilot Study of Nrf2 Pathway Modulation in Oral Mucosa

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

April 30, 2014

Study Completion Date

January 31, 2015

Conditions
Healthy Subject
Interventions
DRUG

Broccoli Sprout Extract (BSE)

"1. The first regimen will involve oral delivery and ingestion of 600 μmole doses of glucoraphanin-rich BSE (GRR-BSE), and will represent systemic delivery of sulforaphane to oral mucosa, due to the necessity to metabolize GRR-BSE in the gut.~2. The second regimen will involve oral delivery and ingestion of 100 μmole doses of sulforaphane-rich BSE (SFR-BSE), which will represent a combination of systemic and topical delivery to the oral mucosa.~3. The third regimen will isolate topical exposure of the oral mucosa to sulforaphane. Participants will swish, hold, then spit 100 μmole doses of SFR-BSE. This regimen (SFR-BSE(T)) will theoretically isolate the pharmacodynamic impact of topical exposure of the oral mucosa to sulforaphane."

Trial Locations (2)

15213

Eye and Ear Institute, Pittsburgh

15232

UPMC Hillman Cancer Center (University of Pittsburgh Cancer Institute), Pittsburgh

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Julie E. Bauman, MD, MPH

OTHER

NCT02023931 - Broccoli Sprout Extracts in Healthy Volunteers: A Pilot Study of Nrf2 Pathway Modulation in Oral Mucosa | Biotech Hunter | Biotech Hunter