NCT01437501

Broccoli Sprout Intervention in Qidong, P.R. China

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 291 (actual)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Environmental Carcinogenesis

Interventions

Type	Name	Description
DRUG	Broccoli Sprout Extract Beverage	Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
DRUG	placebo beverage	100 mL of dilute pineapple and lime juice daily for 84 days.

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-09-21
• Last updated: 2018-08-16
• Results posted: 2013-09-23

Locations

1 site across 1 country: China