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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 : August 16, 2018
Sponsor:
Collaborators:
Johns Hopkins University
National Institute of Environmental Health Sciences (NIEHS)
Qidong Liver Cancer Institute
University of Pittsburgh
University of Minnesota
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Tracking Information
First Submitted Date  ICMJE September 15, 2011
First Posted Date  ICMJE September 21, 2011
Results First Submitted Date  ICMJE May 2, 2013
Results First Posted Date  ICMJE September 23, 2013
Last Update Posted Date August 16, 2018
Study Start Date  ICMJE October 2011
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2013)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2011)
  • Change from baseline in Aflatoxin-DNA Adduct biomarkers 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. ]
    Urinary levels of aflatoxin-DNA adducts.
  • Change from baseline in Aflatoxin 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. ]
  • 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. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2018)
Levels of Sulforaphane and Its Metabolites at the End of Intervention Period (After 84 Daily Doses) [ Time Frame: Endpoints assessed on urine samples collected at the end of the intervention (day 84 [week 12]) ]
Micromoles of urinary sulforaphane metabolites excreted over 24 hours after consuming the 84th dose.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2011)
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. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Broccoli Sprout Intervention in Qidong, P.R. China
Official Title  ICMJE Broccoli Sprout Intervention in Qidong, P.R. China
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Environmental Carcinogenesis
Intervention  ICMJE
  • 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.
  • Drug: placebo beverage
    100 mL of dilute pineapple and lime juice daily for 84 days.
Study Arms  ICMJE
  • Experimental: Broccoli Sprout Extract Beverage
    Intervention: Drug: Broccoli Sprout Extract Beverage
  • Placebo Comparator: Placebo beverage
    Intervention: Drug: placebo beverage
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2013)
291
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2011)
300
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01437501
Other Study ID Numbers  ICMJE IRB00003494
5P01ES006052 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins Bloomberg School of Public Health
Study Sponsor  ICMJE Johns Hopkins Bloomberg School of Public Health
Collaborators  ICMJE
  • Johns Hopkins University
  • National Institute of Environmental Health Sciences (NIEHS)
  • Qidong Liver Cancer Institute
  • University of Pittsburgh
  • University of Minnesota
Investigators  ICMJE
Principal Investigator: Thomas W Kensler, PhD Johns Hopkins Bloomberg School of Public Health
PRS Account Johns Hopkins Bloomberg School of Public Health
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP