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Cross-Over Broccoli Sprouts Trial

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ClinicalTrials.gov Identifier: NCT01008826
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : September 16, 2011
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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

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
Primary Completion Date : November 2009
Study Completion Date : December 2009
Arms and Interventions

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (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

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
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
Principal Investigator: Thomas W Kensler, PhD Johns Hopkins Bloomberg School of Public Health
More Information

Responsible Party: Thomas Kensler, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01008826     History of Changes
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

Additional relevant MeSH terms:
Sulforafan
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents