Cross-Over Broccoli Sprouts Trial
2 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Oct 2009
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 5, 2009
CompletedFirst Posted
Study publicly available on registry
November 6, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedSeptember 16, 2011
September 1, 2011
1 month
November 5, 2009
September 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Urinary levels of glucoraphanin or sulforaphane and metabolites.
Endpoints will be assessed on urine samples collected daily during the intervention.
Secondary Outcomes (1)
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.
Study Arms (2)
glucoraphanin-rich broccoli extract
EXPERIMENTALsulforaphane-rich broccoli extract
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Qidong Liver Cancer Institute
Qidong, Jiangsu, 226200, China
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas W Kensler, PhD
Johns Hopkins Bloomberg School of Public Health
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 5, 2009
First Posted
November 6, 2009
Study Start
October 1, 2009
Primary Completion
November 1, 2009
Study Completion
December 1, 2009
Last Updated
September 16, 2011
Record last verified: 2011-09