Broccoli Sprout Dose Response: Bioavailability and Effects of Air Pollutants

Study Overview
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Brief Summary
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This study will examine the extent to which lower doses of a broccoli-derived beverage enhance the detoxication of air pollutants excreted in urine as compared to an maximal dose shown to be effective previously.

Detailed Description
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This is a 10-day placebo control Phase II broccoli sprout intervention to be conducted in Qidong, P.R. China. Up to twelve hundred people from the farming townships will be screened and one hundred seventy eligible individuals will be enrolled in the study. Participants will be randomized into 4 treatment groups: one will receive a juice beverage containing a standard dose of glucoraphanin- and sulforaphane-rich broccoli sprout powder mixed in pineapple juice, lime juice and water, the second will receive one-half dose, the third one-fifth dose and the fourth group will receive placebo beverage containing pineapple juice, lime juice and water. Participants will drink their assigned beverage every evening and provide consecutive 12-hour urine collections throughout the duration of the study.

Official Title
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Broccoli Sprout Dose Response: Bioavailability and Effects on Air Pollutants

Conditions
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Environmental Carcinogenesis

Intervention / Treatment
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* Drug: Broccoli Sprout-derived Beverage
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: in good general health with no history of chronic illness normal liver function tests normal renal function tests Exclusion Criteria: personal history of cancer except for non-melanoma skin cancer use of prescribed medicines 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 |
| --- | --- |
| Placebo Comparator: Placebos<br>Beverage (100 mL) containing pineapple juice, lime juice and water. Nightly for 10 days. | Drug: Placebos<br>* Placebo as comparison to broccoli sprout-derived beverages<br>|
| Experimental: High Dose Broccoli Sprout<br>Beverage (100 mL) containing glucoraphanin-rich (600 micromole) and sulforaphane-rich (40 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days. | Drug: Broccoli Sprout-derived Beverage<br>* Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebos.<br>|
| Experimental: Medium Dose Broccoli Sprout<br>Beverage (100 mL) containing glucoraphanin-rich (300 micromole) and sulforaphane-rich (20 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days. | Drug: Broccoli Sprout-derived Beverage<br>* Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebos.<br>|
| Experimental: Low Dose Broccoli Sprout<br>Beverage (100 mL) containing glucoraphanin-rich (120 micromole) and sulforaphane-rich (8 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days. | Drug: Broccoli Sprout-derived Beverage<br>* Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebos.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sulforaphane Bioavailability Measured in Sequential 12-Hour Urine Samples | Urinary excretion of broccoli-derived sulforaphane metabolites: sulforaphane-mercapturic acid. The metabolites were measured all 20 of the sequential 12-hour urine collections from each participant over the 10-day intervention period. Data from each individual were summed to provide a single per 24-hours value for each participant. | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modulation of Air Pollutant Excretion in Sequential Overnight 12-Hour Urine Samples | Benzene-mercapturic acid (SPMA) excretion was measured in the sequential overnight 12-hour urine samples collected across the 10-day study period. Data from each individual were summed and averaged to provide a single per 12-hours value for each participant. | 10 days |