Cross-Over Broccoli Sprouts Trial

Cross-Over Broccoli Sprouts Trial - Qidong

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: broccoli sprouts extract

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Qidong, Jiangsu, China, 226200
      • Qidong Liver Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Urinary levels of glucoraphanin or sulforaphane and metabolites.	Endpoints will be assessed on urine samples collected daily during the intervention.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: Qidong Liver Cancer Institute
• Investigators: Principal Investigator: Thomas W Kensler, PhD, Johns Hopkins Bloomberg School of Public Health

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: November 5, 2009
• First Submitted That Met QC Criteria: November 5, 2009
• First Posted (Estimate): November 6, 2009

Study Record Updates

• Last Update Posted (Estimate): September 16, 2011
• Last Update Submitted That Met QC Criteria: September 15, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: pharmacokinetics; sulforaphane
• Other Study ID Numbers: IRB00002015; 5P01ES006052 (U.S. NIH Grant/Contract)