Cross-Over Broccoli Sprouts Trial

Phase 1

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: broccoli sprouts extract

• Registration Number: NCT01008826
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2009-11
• Study First Submitted: 2009-11-05
• Study First Submitted QC: 2009-11-05
• Study First Posted: 2009-11-06
• Study Completion: 2009-12
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-15
• Last Update Posted: 2011-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
glucoraphanin-rich broccoli extract	broccoli sprouts extract	-
sulforaphane-rich broccoli extract	broccoli sprouts extract	-

Primary Outcome Measures

Name	Time	Method
Urinary levels of glucoraphanin or sulforaphane and metabolites.	Endpoints will be assessed on urine samples collected daily during the intervention.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

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