Broccoli Sprout Intervention in Qidong, P.R. China

This study has been completed.

Sponsor:

Collaborators:

Johns Hopkins University

National Institute of Environmental Health Sciences (NIEHS)

Qidong Liver Cancer Institute

University of Pittsburgh

University of Minnesota - Clinical and Translational Science Institute

Information provided by (Responsible Party):

Thomas Kensler, Johns Hopkins Bloomberg School of Public Health

ClinicalTrials.gov Identifier:

NCT01437501

First received: September 15, 2011

Last updated: February 26, 2013

Last verified: February 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
Environmental Carcinogenesis	Drug: Broccoli Sprout Extract Beverage Drug: placebo beverage	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Official Title:	Broccoli Sprout Intervention in Qidong, P.R. China

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:

Change from baseline in air toxics mercapturic acids over intervention period [ 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in levels of Glucoraphanin/Sulforaphane and their metabolites over intervention period [ 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. ] [ Designated as safety issue: No ]

Enrollment:	291
Study Start Date:	October 2011
Study Completion Date:	January 2012
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Broccoli Sprout Extract Beverage	Drug: Broccoli Sprout Extract Beverage Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
Placebo Comparator: Placebo beverage	Drug: placebo beverage 100 mL of dilute pineapple and lime juice daily for 84 days.

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437501

Locations

China, Jiangsu
Qidong Liver Cancer Institute
Qidong, Jiangsu, China, 226200

Sponsors and Collaborators

Johns Hopkins Bloomberg School of Public Health

Johns Hopkins University

National Institute of Environmental Health Sciences (NIEHS)

Qidong Liver Cancer Institute

University of Pittsburgh

University of Minnesota - Clinical and Translational Science Institute

More Information

Publications:

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.

Egner PA, Chen JG, Wang JB, Wu Y, Sun Y, Lu JH, Zhu J, Zhang YH, Chen YS, Friesen MD, Jacobson LP, Muñoz 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.

Responsible Party:	Thomas Kensler, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:	NCT01437501 History of Changes
Other Study ID Numbers:	IRB00003494, 5P01ES006052
Study First Received:	September 15, 2011
Last Updated:	February 26, 2013
Health Authority:	United States: Food and Drug Administration China: Food and Drug Administration

Keywords provided by Johns Hopkins Bloomberg School of Public Health:

glucoraphanin
sulforaphane
pharmacokinetics

pharmacodynamics
broccoli sprout
carcinogens, environment

ClinicalTrials.gov processed this record on June 17, 2013

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