Broccoli Sprout Intervention in Qidong, P.R. China
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Details and patient eligibility
About
This study is a 12 week placebo-controlled Phase II broccoli sprout intervention to be conducted in Qidong, P.R. China. One thousand two hundred people from the farming townships will be screened and three hundred eligible individuals will be enrolled in the study. Participants will be randomized into two treatment groups: one will receive a juice beverage containing glucoraphanin- and sulforaphane-rich broccoli sprout extract, pineapple juice, lime juice, and water and the other will receive a placebo beverage containing pineapple juice, lime juice and water. Participants will drink their assigned beverage every evening and provide biweekly urine samples and monthly blood samples. The principal endpoints of this study are pharmacokinetic evaluation of elimination of glucoraphanin/sulforaphane and their metabolites in urine and pharmacodynamic evaluation through measures of urinary levels of exposure biomarkers for dietary and air-borne toxins, which are known to be high in this population.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- age 21-65 years
- in good general health with no history of chronic illness
- normal liver function tests: alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin)
- normal renal function tests (creatinine, blood urea nitrogen, 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
291 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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