Broccoli Sprout Intervention in Qidong, P.R. China
Phase 2
21 Years
65 Years
21 Years
65 Years
Not Enrolling
Both
Environmental Carcinogenesis
Both
Environmental Carcinogenesis
Trial Information
Broccoli Sprout Intervention in Qidong, P.R. China
Inclusion Criteria:
- age 21-65 years
- in good general health with no history of 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
- for women, a positive pregnancy test
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Outcome Measure:
Change from baseline in air toxics mercapturic acids over intervention period
Outcome Time Frame:
Endpoints will be assessed on urine and blood samples collected during the intervention on weeks 0, 1, 2, 4, 6, 8, 10 and 12.
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
IRB00003494
NCT ID:
NCT01437501
Start Date:
October 2011
Completion Date:
January 2012
Related Keywords:
- Environmental Carcinogenesis
- glucoraphanin
- sulforaphane
- pharmacokinetics
- pharmacodynamics
- broccoli sprout
- carcinogens, environment
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