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Broccoli Sprout Intervention in Qidong, P.R. China

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ClinicalTrials.gov Identifier: NCT01437501
Recruitment Status : Completed
First Posted : September 21, 2011
Results First Posted : September 23, 2013
Last Update Posted : September 23, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Environmental Carcinogenesis Drug: Broccoli Sprout Extract Beverage Drug: placebo beverage Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 291 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Broccoli Sprout Intervention in Qidong, P.R. China
Study Start Date : October 2011
Primary Completion Date : January 2012
Study Completion Date : January 2012
Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Effect of Treatment on Levels of Air Toxics Mercapturic Acids Over Intervention Period [ Time Frame: Endpoints were assessed on urine samples collected at the end of the intervention on week 12. ]
    Urinary excretion of benzene mercapturic acid (S-PMA) in 12 hour overnight void at 12 weeks


Secondary Outcome Measures :
  1. Change From Baseline in Levels of Glucoraphanin/Sulforaphane and Their Metabolites Over Intervention Period [ Time Frame: Endpoints assessed on urine and blood samples collected during the intervention on weeks 0, 1, 2, 4, 6, 8, 10 and 12. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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: 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Investigators
Principal Investigator: Thomas W Kensler, PhD Johns Hopkins Bloomberg School of Public Health
More Information

Publications:
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 ( U.S. NIH Grant/Contract )
First Posted: September 21, 2011    Key Record Dates
Results First Posted: September 23, 2013
Last Update Posted: September 23, 2013
Last Verified: September 2013

Keywords provided by Thomas Kensler, Johns Hopkins Bloomberg School of Public Health:
glucoraphanin
sulforaphane
pharmacokinetics
pharmacodynamics
broccoli sprout
carcinogens, environment

Additional relevant MeSH terms:
Carcinogenesis
Neoplastic Processes
Neoplasms
Pathologic Processes