Broccoli Sprout Intervention in Qidong, P.R. China

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

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

Criteria

Inclusion Criteria:

• age 21-65 years

• in good general health with no history of chronic illness

• normal liver function tests: alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin)

• normal renal function tests (creatinine, blood urea nitrogen, 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

• for women, a positive pregnancy test