Cross-Over Broccoli Sprouts Trial

Johns Hopkins Bloomberg School of Public Health

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Dietary Supplement: broccoli sprouts extract

Study type

Interventional

Funder types

Other

Identifiers

NCT01008826

5P01ES006052 (U.S. NIH Grant/Contract)

IRB00002015

Details and patient eligibility

About

The study hypothesis tested is that broccoli sprouts are effective at altering the urinary levels of metabolites of the hepatocarcinogen aflatoxin B1 and of the air-borne pollutant phenanthrene in residents of Qidong, PRC, where exposures are unavoidable and high. The study will evaluate which of two formulations of broccoli sprouts beverage, glucoraphanin-rich or sulforaphane-rich, exhibits the best bioavailability and is most effective at modulating the biomarkers.

Enrollment

50 estimated patients

Sex

All

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Adults aged 25-65 in good general health with no history of a chronic illness
normal liver function tests (ALT, AST, bilirubin)
normal renal function tests (creatinine, BUN, urinalysis)
serum alpha-fetoprotein negative

Exclusion criteria

personal history of cancer, except for non-melanoma skin cancer
use of prescribed medications
hepatomegaly by clinical exam
unwillingness to avoid cruciferous vegetable consumption for the duration of the study
for women, a positive pregnancy test.