Broccoli Sprout Intervention in Qidong, P.R. China
Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
Summary
This study is a 12 week placebo-controlled Phase II broccoli sprout intervention to be
conducted in Qidong, P.R. China. One thousand two hundred people from the farming townships
will be screened and three hundred eligible individuals will be enrolled in the study.
Participants will be randomized into two treatment groups: one will receive a juice beverage
containing glucoraphanin- and sulforaphane-rich broccoli sprout extract, pineapple juice,
lime juice, and water and the other will receive a placebo beverage containing pineapple
juice, lime juice and water. Participants will drink their assigned beverage every evening
and provide biweekly urine samples and monthly blood samples. The principal endpoints of this
study are pharmacokinetic evaluation of elimination of glucoraphanin/sulforaphane and their
metabolites in urine and pharmacodynamic evaluation through measures of urinary levels of
exposure biomarkers for dietary and air-borne toxins, which are known to be high in this
population.
Phase:
Phase 2
Details
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborators:
Johns Hopkins University National Institute of Environmental Health Sciences (NIEHS) Qidong Liver Cancer Institute University of Minnesota University of Minnesota - Clinical and Translational Science Institute University of Pittsburgh