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Cross-Over Broccoli Sprouts Trial

This study has been completed.
Sponsor:
Collaborator:
Qidong Liver Cancer Institute
Information provided by (Responsible Party):
Thomas Kensler, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01008826
First received: November 5, 2009
Last updated: September 15, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Dietary Supplement: broccoli sprouts extract
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Cross-Over Broccoli Sprouts Trial - Qidong

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Urinary levels of glucoraphanin or sulforaphane and metabolites. [ Time Frame: Endpoints will be assessed on urine samples collected daily during the intervention. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 School of Public Health
  More Information

No publications provided

Responsible Party: Thomas Kensler, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01008826     History of Changes
Other Study ID Numbers: IRB00002015, 5P01 ES006052
Study First Received: November 5, 2009
Last Updated: September 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
sulforaphane
pharmacokinetics

Additional relevant MeSH terms:
Sulforafan
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013