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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
291
Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
100 mL of dilute pineapple and lime juice daily for 84 days.
Qidong Liver Cancer Institute
Qidong, Jiangsu, China
Effect of Treatment on Levels of Air Toxics Mercapturic Acids Over Intervention Period
Urinary excretion of benzene mercapturic acid (S-PMA) in 12 hour overnight void at 12 weeks
Time frame: Endpoints were assessed on urine samples collected at the end of the intervention on week 12.
Levels of Sulforaphane and Its Metabolites at the End of Intervention Period (After 84 Daily Doses)
Micromoles of urinary sulforaphane metabolites excreted over 24 hours after consuming the 84th dose.
Time frame: Endpoints assessed on urine samples collected at the end of the intervention (day 84 [week 12])
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