Broccoli Sprout Intervention in Qidong, P.R. China

Phase 2

Completed

• Conditions: Environmental Carcinogenesis
• Interventions: Drug: Broccoli Sprout Extract Beverage; Drug: placebo beverage

• Registration Number: NCT01437501
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

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

Not available

Study Timeline

• Study First Submitted: 2011-09-15
• Study First Submitted QC: 2011-09-20
• Study First Posted: 2011-09-21
• Study Start: 2011-10
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2013-05-02
• Results First Submitted QC: 2013-09-19
• Results First Posted: 2013-09-23
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Broccoli Sprout Extract Beverage	Broccoli Sprout Extract Beverage	-
Placebo beverage	placebo beverage	-

Primary Outcome Measures

Name	Time	Method
Effect of Treatment on Levels of Air Toxics Mercapturic Acids Over Intervention Period	Endpoints were assessed on urine samples collected at the end of the intervention on week 12.	Urinary excretion of benzene mercapturic acid (S-PMA) in 12 hour overnight void at 12 weeks

Secondary Outcome Measures

Name	Time	Method
Levels of Sulforaphane and Its Metabolites at the End of Intervention Period (After 84 Daily Doses)	Endpoints assessed on urine samples collected at the end of the intervention (day 84 [week 12])	Micromoles of urinary sulforaphane metabolites excreted over 24 hours after consuming the 84th dose.

Trial Locations

Locations (1)

Qidong Liver Cancer Institute; 🇨🇳 Qidong, Jiangsu, China