Broccoli Sprout Intervention in Qidong, P.R. China

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

291 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Environmental Carcinogenesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Broccoli Sprout Extract Beverage

Group Type EXPERIMENTAL

Broccoli Sprout Extract Beverage

Intervention Type DRUG

Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.

Placebo beverage

Group Type PLACEBO_COMPARATOR

placebo beverage

Intervention Type DRUG

100 mL of dilute pineapple and lime juice daily for 84 days.

Interventions

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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.

Intervention Type DRUG

placebo beverage

100 mL of dilute pineapple and lime juice daily for 84 days.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes