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Broccoli Sprout Dose Response: Bioavailability and Effects of Air Pollutants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Environmental Carcinogenesis Drug: Broccoli Sprout-derived Beverage Drug: Placebos Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Broccoli Sprout Dose Response: Bioavailability and Effects on Air Pollutants
Study Start Date : January 2016
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebos
Beverage (100 mL) containing pineapple juice, lime juice and water. Nightly for 10 days.
 Drug: Placebos
Placebo as comparison to broccoli sprout-derived beverages
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.
 Drug: Broccoli Sprout-derived Beverage
Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebos.
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.
 Drug: Broccoli Sprout-derived Beverage
Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebos.
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.
 Drug: Broccoli Sprout-derived Beverage
Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebos.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT02656420


Locations
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China, Jiangsu
Qidong Liver Cancer Institute
Qidong, Jiangsu, China, 226200
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Qidong Liver Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Thomas Kensler, PhD Johns Hopkins Bloomberg School of Public Health
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT02656420    
Other Study ID Numbers: IRB00006734
R01CA190610 ( U.S. NIH Grant/Contract )
First Posted: January 15, 2016    Key Record Dates
Results First Posted: May 1, 2019
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Carcinogenesis
Neoplastic Processes
Neoplasms
Pathologic Processes