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Broccoli Sprout Dose Response: Bioavailability and Effects of Air Pollutants

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ClinicalTrials.gov Identifier: NCT02656420
Recruitment Status : Completed
First Posted : January 15, 2016
Results First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Collaborators:
Qidong Liver Cancer Institute
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Tracking Information
First Submitted Date  ICMJE January 5, 2016
First Posted Date  ICMJE January 15, 2016
Results First Submitted Date  ICMJE July 19, 2018
Results First Posted Date  ICMJE May 1, 2019
Last Update Posted Date May 1, 2019
Study Start Date  ICMJE January 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
Sulforaphane Bioavailability Measured in Sequential 12-Hour Urine Samples [ Time Frame: 10 days ]
Urinary excretion of broccoli-derived sulforaphane metabolites: sulforaphane-mercapturic acid. The metabolites were measured all 20 of the sequential 12-hour urine collections from each participant over the 10-day intervention period. Data from each individual were summed to provide a single "per 24-hours" value for each participant.
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
Sulforaphane Bioavailability Measured in Sequential 12-Hour Urine Samples [ Time Frame: 2 weeks ]
Urinary excretion of broccoli-derived sulforaphane metabolites: sulforaphane-mercapturic acid. The metabolite will be measured in the sequential 12-hour urine collections from each participant over the 2-week period.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
Modulation of Air Pollutant Excretion in Sequential Overnight 12-Hour Urine Samples [ Time Frame: 10 days ]
Benzene-mercapturic acid (SPMA) excretion was measured in the sequential overnight 12-hour urine samples collected across the 10-day study period. Data from each individual were summed and averaged to provide a single "per 12-hours" value for each participant.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
Modulation of Air Pollutant Excretion in Sequential 12-Hour Urine Samples [ Time Frame: 2 weeks ]
Benzene-mercapturic acid excretion will be measured in the sequential 12-hour urine samples collected across the 2-week study period.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Broccoli Sprout Dose Response: Bioavailability and Effects of Air Pollutants
Official Title  ICMJE Broccoli Sprout Dose Response: Bioavailability and Effects on Air Pollutants
Brief Summary This study will examine the extent to which lower doses of a broccoli-derived beverage enhance the detoxication of air pollutants excreted in urine as compared to an maximal dose shown to be effective previously.
Detailed Description This is a 10-day placebo control Phase II broccoli sprout intervention to be conducted in Qidong, P.R. China. Up to twelve hundred people from the farming townships will be screened and one hundred seventy eligible individuals will be enrolled in the study. Participants will be randomized into 4 treatment groups: one will receive a juice beverage containing a standard dose of glucoraphanin- and sulforaphane-rich broccoli sprout powder mixed in pineapple juice, lime juice and water, the second will receive one-half dose, the third one-fifth dose and the fourth group will receive placebo beverage containing pineapple juice, lime juice and water. Participants will drink their assigned beverage every evening and provide consecutive 12-hour urine collections throughout the duration of the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
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-derived Beverage
    Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebos.
  • Drug: Placebos
    Placebo as comparison to broccoli sprout-derived beverages
Study Arms  ICMJE
  • Placebo Comparator: Placebos
    Beverage (100 mL) containing pineapple juice, lime juice and water. Nightly for 10 days.
    Intervention: Drug: Placebos
  • Experimental: High Dose Broccoli Sprout
    Beverage (100 mL) containing glucoraphanin-rich (600 micromole) and sulforaphane-rich (40 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.
    Intervention: Drug: Broccoli Sprout-derived Beverage
  • Experimental: Medium Dose Broccoli Sprout
    Beverage (100 mL) containing glucoraphanin-rich (300 micromole) and sulforaphane-rich (20 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.
    Intervention: Drug: Broccoli Sprout-derived Beverage
  • Experimental: Low Dose Broccoli Sprout
    Beverage (100 mL) containing glucoraphanin-rich (120 micromole) and sulforaphane-rich (8 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.
    Intervention: Drug: Broccoli Sprout-derived 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: January 12, 2016)
170
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • in good general health with no history of chronic illness
  • normal liver function tests
  • normal renal function tests

Exclusion Criteria:

  • personal history of cancer except for non-melanoma skin cancer
  • use of prescribed medicines
  • 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 NCT02656420
Other Study ID Numbers  ICMJE IRB00006734
R01CA190610 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins Bloomberg School of Public Health
Study Sponsor  ICMJE Johns Hopkins Bloomberg School of Public Health
Collaborators  ICMJE
  • Qidong Liver Cancer Institute
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Thomas Kensler, PhD Johns Hopkins Bloomberg School of Public Health
PRS Account Johns Hopkins Bloomberg School of Public Health
Verification Date April 2019

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