Clinical trial NCT01437501: Broccoli Sprout Intervention in Qidong, P.R. China
Official title: Broccoli Sprout Intervention in Qidong, P.R. China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Environmental Carcinogenesis
Keywords: glucoraphanin
sulforaphane
pharmacokinetics
pharmacodynamics
broccoli sprout
carcinogens, environment
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: National Institute of Environmental Health Sciences (NIEHS)
name: Qidong Liver Cancer Institute
name: University of Pittsburgh
name: University of Minnesota
First posted: 2011-09-21
Enrollment: 291
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Effect of Treatment on Levels of Air Toxics Mercapturic Acids Over Intervention Period
timeFrame: Endpoints were assessed on urine samples collected at the end of the intervention on week 12.
Secondary outcomes:
measure: Levels of Sulforaphane and Its Metabolites at the End of Intervention Period (After 84 Daily Doses)
timeFrame: Endpoints assessed on urine samples collected at the end of the intervention (day 84 [week 12])
Other outcomes:
Locations:
city: Qidong
country: China
facility: Qidong Liver Cancer Institute
state: Jiangsu
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Thomas W Kensler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kensler TW, Chen JG, Egner PA, Fahey JW, Jacobson LP, Stephenson KK, Ye L, Coady JL, Wang JB, Wu Y, Sun Y, Zhang QN, Zhang BC, Zhu YR, Qian GS, Carmella SG, Hecht SS, Benning L, Gange SJ, Groopman JD, Talalay P. Effects of glucosinolate-rich broccoli sprouts on urinary levels of aflatoxin-DNA adducts and phenanthrene tetraols in a randomized clinical trial in He Zuo township, Qidong, People's Republic of China. Cancer Epidemiol Biomarkers Prev. 2005 Nov;14(11 Pt 1):2605-13. doi: 10.1158/1055-9965.EPI-05-0368.
citation: Egner PA, Chen JG, Wang JB, Wu Y, Sun Y, Lu JH, Zhu J, Zhang YH, Chen YS, Friesen MD, Jacobson LP, Munoz A, Ng D, Qian GS, Zhu YR, Chen TY, Botting NP, Zhang Q, Fahey JW, Talalay P, Groopman JD, Kensler TW. Bioavailability of Sulforaphane from two broccoli sprout beverages: results of a short-term, cross-over clinical trial in Qidong, China. Cancer Prev Res (Phila). 2011 Mar;4(3):384-95. doi: 10.1158/1940-6207.CAPR-10-0296.