Conditions: Environmental Carcinogenesis
Keywords: glucoraphanin sulforaphane pharmacokinetics pharmacodynamics broccoli sprout carcinogens, environment
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 291
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Broccoli Sprout Extract Beverage intervention 2: placebo beverage
Intervention descriptions: intervention 1: Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days. intervention 2: 100 mL of dilute pineapple and lime juice daily for 84 days.

Protocol document: