Cross-Over Broccoli Sprouts Trial

Study Overview
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Brief Summary
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The study hypothesis tested is that broccoli sprouts are effective at altering the urinary levels of metabolites of the hepatocarcinogen aflatoxin B1 and of the air-borne pollutant phenanthrene in residents of Qidong, PRC, where exposures are unavoidable and high. The study will evaluate which of two formulations of broccoli sprouts beverage, glucoraphanin-rich or sulforaphane-rich, exhibits the best bioavailability and is most effective at modulating the biomarkers.

Official Title
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Cross-Over Broccoli Sprouts Trial - Qidong

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: broccoli sprouts extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 25-65 in good general health with no history of a chronic illness normal liver function tests (ALT, AST, bilirubin) normal renal function tests (creatinine, BUN, 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 unwillingness to avoid cruciferous vegetable consumption for the duration of the study for women, a positive pregnancy test.

Ages Eligible for Study
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Minimum Age: 25 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: glucoraphanin-rich broccoli extract<br> | Dietary Supplement: broccoli sprouts extract<br>* Glucoraphanin-rich broccoli sprouts extract: 800 micromoles daily for 7 days dissolved in 100 mL of dilute mango juice Sulforaphane-rich broccoli sprouts extract: 150 micromoles daily for 7 days dissolved in 100 mL of dilute mango juice<br>|
| Experimental: sulforaphane-rich broccoli extract<br> | Dietary Supplement: broccoli sprouts extract<br>* Glucoraphanin-rich broccoli sprouts extract: 800 micromoles daily for 7 days dissolved in 100 mL of dilute mango juice Sulforaphane-rich broccoli sprouts extract: 150 micromoles daily for 7 days dissolved in 100 mL of dilute mango juice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary levels of glucoraphanin or sulforaphane and metabolites. |  | Endpoints will be assessed on urine samples collected daily during the intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary levels of aflatoxin-DNA adducts and mercapturic acids as well as mercapturic acids of air-borne pollutants |  | Endpoints will be assessed on urine samples collected daily during the intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sulforaphane, pharmacokinetics