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Cross-Over Broccoli Sprouts Trial

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: NCT01008826
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : September 16, 2011
Sponsor:
Collaborator:
Qidong Liver Cancer Institute
Information provided by (Responsible Party):
Thomas Kensler, Johns Hopkins Bloomberg School of Public Health

Study Description
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Brief Summary:
The study hypothesis tested is that broccoli sprouts are effective at altering the urinary levels of metabolites of the hepatocarcinogen aflatoxin B1 and of the air-borne pollutant phenanthrene in residents of Qidong, PRC, where exposures are unavoidable and high. The study will evaluate which of two formulations of broccoli sprouts beverage, glucoraphanin-rich or sulforaphane-rich, exhibits the best bioavailability and is most effective at modulating the biomarkers.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: broccoli sprouts extract Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Cross-Over Broccoli Sprouts Trial - Qidong
Study Start Date : October 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: glucoraphanin-rich broccoli extract Dietary Supplement: broccoli sprouts extract
Glucoraphanin-rich broccoli sprouts extract: 800 micromoles daily for 7 days dissolved in 100 mL of dilute mango juice Sulforaphane-rich broccoli sprouts extract: 150 micromoles daily for 7 days dissolved in 100 mL of dilute mango juice
Experimental: sulforaphane-rich broccoli extract Dietary Supplement: broccoli sprouts extract
Glucoraphanin-rich broccoli sprouts extract: 800 micromoles daily for 7 days dissolved in 100 mL of dilute mango juice Sulforaphane-rich broccoli sprouts extract: 150 micromoles daily for 7 days dissolved in 100 mL of dilute mango juice


Outcome Measures
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Primary Outcome Measures :
  1. Urinary levels of glucoraphanin or sulforaphane and metabolites. [ Time Frame: Endpoints will be assessed on urine samples collected daily during the intervention. ]

Secondary Outcome Measures :
  1. Urinary levels of aflatoxin-DNA adducts and mercapturic acids as well as mercapturic acids of air-borne pollutants [ Time Frame: Endpoints will be assessed on urine samples collected daily during the intervention. ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults aged 25-65 in good general health with no history of a chronic illness
  • normal liver function tests (ALT, AST, bilirubin)
  • normal renal function tests (creatinine, BUN, 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
  • unwillingness to avoid cruciferous vegetable consumption for the duration of the study
  • 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): NCT01008826


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
Investigators
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Principal Investigator: Thomas W Kensler, PhD Johns Hopkins Bloomberg School of Public Health
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Thomas Kensler, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01008826    
Other Study ID Numbers: IRB00002015
5P01ES006052 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: September 16, 2011
Last Verified: September 2011
Keywords provided by Thomas Kensler, Johns Hopkins Bloomberg School of Public Health:
sulforaphane
pharmacokinetics