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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Environmental Carcinogenesis
Interventions Drug: Broccoli Sprout Extract Beverage
Drug: placebo beverage
Enrollment 291
Recruitment Details 1205 Individuals were recruited from HeHe Township in Qidong, PRC for eligibility screening at 3 medical clinics within the township in September 2011.
Pre-assignment Details  
Arm/Group Title Broccoli Sprout Extract Beverage Placebo Beverage
Hide Arm/Group Description 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 beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
Period Title: Overall Study
Started 148 143
Completed 135 132
Not Completed 13 11
Arm/Group Title Broccoli Sprout Extract Beverage Placebo Beverage Total
Hide Arm/Group Description 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 beverage : 100 mL of dilute pineapple and lime juice daily for 84 days. Total of all reporting groups
Overall Number of Baseline Participants 148 143 291
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants 143 participants 291 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
148
 100.0%
143
 100.0%
291
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 148 participants 143 participants 291 participants
51.1  (9.4) 52.6  (7.7) 51.8  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants 143 participants 291 participants
Female
118
  79.7%
111
  77.6%
229
  78.7%
Male
30
  20.3%
32
  22.4%
62
  21.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 148 participants 143 participants 291 participants
148 143 291
1.Primary Outcome
Title Effect of Treatment on Levels of Air Toxics Mercapturic Acids Over Intervention Period
Hide Description Urinary excretion of benzene mercapturic acid (S-PMA) in 12 hour overnight void at 12 weeks
Time Frame Endpoints were assessed on urine samples collected at the end of the intervention on week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were conducted on all urine samples provided by study participants at week 12.
Arm/Group Title Broccoli Sprout Extract Beverage Placebo Beverage
Hide Arm/Group Description:
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 beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
Overall Number of Participants Analyzed 135 132
Median (Inter-Quartile Range)
Unit of Measure: pmol/mg creatinine
1.700
(1.235 to 2.386)
1.065
(0.686 to 1.826)
2.Secondary Outcome
Title Levels of Sulforaphane and Its Metabolites at the End of Intervention Period (After 84 Daily Doses)
Hide Description Micromoles of urinary sulforaphane metabolites excreted over 24 hours after consuming the 84th dose.
Time Frame Endpoints assessed on urine samples collected at the end of the intervention (day 84 [week 12])
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Beverage Broccoli Sprout Extract Beverage
Hide Arm/Group Description:
placebo beverage: 100 mL of dilute pineapple and lime juice daily for 84 days.
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.
Overall Number of Participants Analyzed 132 135
Median (Inter-Quartile Range)
Unit of Measure: micromoles
1
(1 to 1)
62
(44 to 91)
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Broccoli Sprout Extract Beverage Placebo Beverage
Hide Arm/Group Description 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 beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
All-Cause Mortality
Broccoli Sprout Extract Beverage Placebo Beverage
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Broccoli Sprout Extract Beverage Placebo Beverage
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/148 (0.00%)      0/143 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.3%
Broccoli Sprout Extract Beverage Placebo Beverage
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/148 (4.05%)      4/143 (2.80%)    
Gastrointestinal disorders     
light vomiting *  1/148 (0.68%)  1 0/143 (0.00%)  0
indigestion *  4/148 (2.70%)  4 2/143 (1.40%)  2
taste * [1]  1/148 (0.68%)  1 2/143 (1.40%)  2
*
Indicates events were collected by non-systematic assessment
[1]
participants disliked taste, worried about participation, withdrew from study
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas W. Kensler, PhD
Organization: Johns Hopkins Bloomberg School of Public Health
Phone: 410-955-1292
EMail: tkensler@jhsph.edu
Layout table for additonal information
Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01437501    
Other Study ID Numbers: IRB00003494
5P01ES006052 ( U.S. NIH Grant/Contract )
First Submitted: September 15, 2011
First Posted: September 21, 2011
Results First Submitted: May 2, 2013
Results First Posted: September 23, 2013
Last Update Posted: August 16, 2018