Broccoli Sprout Intervention in Qidong, P.R. China

This study has been completed.
Sponsor:
Collaborators:
Johns Hopkins University
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: September 19, 2013
Last verified: September 2013
  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:
  • 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. ] [ Designated as safety issue: No ]
    Urinary excretion of benzene mercapturic acid (S-PMA) in 12 hour overnight void at 12 weeks


Secondary Outcome Measures:
  • 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. ] [ 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: 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
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
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
Study First Received: September 15, 2011
Results First Received: May 2, 2013
Last Updated: September 19, 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

Additional relevant MeSH terms:
Sulforafan
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014