Broccoli Sprout Intervention in Qidong, P.R. China

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

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.

Sponsors & Collaborators

• Johns Hopkins University

  collaborator OTHER

• National Institute of Environmental Health Sciences (NIEHS)

  collaborator NIH

• Qidong Liver Cancer Institute

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• University of Minnesota

  collaborator OTHER

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

• Thomas W Kensler, PhD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-10-31

Primary Completion

2012-01-31

Completion

2012-01-31

Countries

• China

Study Locations