Cross-Over Broccoli Sprouts Trial

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

Tracking Information

• First Submitted Date: November 5, 2009
• First Posted Date: November 6, 2009
• Last Update Posted Date: September 16, 2011
• Study Start Date: October 2009
• Actual Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 5, 2009): Urinary levels of glucoraphanin or sulforaphane and metabolites. [ Time Frame: Endpoints will be assessed on urine samples collected daily during the intervention. ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: November 5, 2009): 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. ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cross-Over Broccoli Sprouts Trial
• Official Title: Cross-Over Broccoli Sprouts Trial - Qidong
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

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

Study Arms

• Experimental: glucoraphanin-rich broccoli extract
  Intervention: Dietary Supplement: broccoli sprouts extract
• Experimental: sulforaphane-rich broccoli extract
  Intervention: Dietary Supplement: broccoli sprouts extract

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: November 5, 2009): 50
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2009
• Actual Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01008826
• Other Study ID Numbers: IRB00002015; 5P01ES006052 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Thomas Kensler, Johns Hopkins Bloomberg School of Public Health
• Original Responsible Party: Thomas W. Kensler, Johns Hopkins School of Public Health
• Current Study Sponsor: Johns Hopkins Bloomberg School of Public Health
• Original Study Sponsor: Same as current
• Collaborators: Qidong Liver Cancer Institute

Investigators

• Principal Investigator: Thomas W Kensler, PhD; Johns Hopkins Bloomberg School of Public Health

• PRS Account: Johns Hopkins Bloomberg School of Public Health
• Verification Date: September 2011