Broccoli Sprout Intervention in Qidong, P.R. China

Study Overview
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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.

Official Title
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Broccoli Sprout Intervention in Qidong, P.R. China

Conditions
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Environmental Carcinogenesis

Intervention / Treatment
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* Drug: Broccoli Sprout Extract Beverage
* Drug: placebo beverage


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Broccoli Sprout Extract Beverage<br> | Drug: Broccoli Sprout Extract Beverage<br>* Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.<br>|
| Placebo Comparator: Placebo beverage<br> | Drug: placebo beverage<br>* 100 mL of dilute pineapple and lime juice daily for 84 days.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sulforaphane, glucoraphanin, pharmacokinetics, pharmacodynamics, broccoli sprout, carcinogens, environment