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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
  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
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, 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. ]

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. ]

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   (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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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 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 ( US NIH Grant/Contract Award Number )
Study First Received: November 5, 2009
Last Updated: September 15, 2011

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
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 24, 2017