Broccoli Sprout Intervention in Qidong, P.R. China

This study is a 12 week placebo-controlled Phase II broccoli sprout intervention to be conducted in Qidong, P.R. China. One thousand two hundred people from the farming townships will be screened and three hundred eligible individuals will be enrolled in the study. Participants will be randomized into two treatment groups: one will receive a juice beverage containing glucoraphanin- and sulforaphane-rich broccoli sprout extract, pineapple juice, lime juice, and water and the other will receive a placebo beverage containing pineapple juice, lime juice and water. Participants will drink their assigned beverage every evening and provide biweekly urine samples and monthly blood samples. The principal endpoints of this study are pharmacokinetic evaluation of elimination of glucoraphanin/sulforaphane and their metabolites in urine and pharmacodynamic evaluation through measures of urinary levels of exposure biomarkers for dietary and air-borne toxins, which are known to be high in this population.

Study Overview

• Status: Completed
• Conditions: Environmental Carcinogenesis
• Intervention / Treatment: Drug: Broccoli Sprout Extract Beverage; Drug: placebo beverage

• Study Type: Interventional
• Enrollment (Actual): 291
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age 21-65 years
• in good general health with no history of chronic illness
• normal liver function tests: alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin)
• normal renal function tests (creatinine, blood urea nitrogen, 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
• for women, a positive pregnancy test

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Broccoli Sprout Extract Beverage	Drug: Broccoli Sprout Extract Beverage; Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
Placebo Comparator: Placebo beverage	Drug: placebo beverage; 100 mL of dilute pineapple and lime juice daily for 84 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Treatment on Levels of Air Toxics Mercapturic Acids Over Intervention Period	Urinary excretion of benzene mercapturic acid (S-PMA) in 12 hour overnight void at 12 weeks	Endpoints were assessed on urine samples collected at the end of the intervention on week 12.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of Sulforaphane and Its Metabolites at the End of Intervention Period (After 84 Daily Doses)	Micromoles of urinary sulforaphane metabolites excreted over 24 hours after consuming the 84th dose.	Endpoints assessed on urine samples collected at the end of the intervention (day 84 [week 12])

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: Johns Hopkins University; University of Pittsburgh; University of Minnesota; National Institute of Environmental Health Sciences (NIEHS); Qidong Liver Cancer Institute
• Investigators: Principal Investigator: Thomas W Kensler, PhD, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

General Publications

• Egner PA, Chen JG, Wang JB, Wu Y, Sun Y, Lu JH, Zhu J, Zhang YH, Chen YS, Friesen MD, Jacobson LP, Munoz A, Ng D, Qian GS, Zhu YR, Chen TY, Botting NP, Zhang Q, Fahey JW, Talalay P, Groopman JD, Kensler TW. Bioavailability of Sulforaphane from two broccoli sprout beverages: results of a short-term, cross-over clinical trial in Qidong, China. Cancer Prev Res (Phila). 2011 Mar;4(3):384-95. doi: 10.1158/1940-6207.CAPR-10-0296.
• Kensler TW, Chen JG, Egner PA, Fahey JW, Jacobson LP, Stephenson KK, Ye L, Coady JL, Wang JB, Wu Y, Sun Y, Zhang QN, Zhang BC, Zhu YR, Qian GS, Carmella SG, Hecht SS, Benning L, Gange SJ, Groopman JD, Talalay P. Effects of glucosinolate-rich broccoli sprouts on urinary levels of aflatoxin-DNA adducts and phenanthrene tetraols in a randomized clinical trial in He Zuo township, Qidong, People's Republic of China. Cancer Epidemiol Biomarkers Prev. 2005 Nov;14(11 Pt 1):2605-13. doi: 10.1158/1055-9965.EPI-05-0368.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: September 15, 2011
• First Submitted That Met QC Criteria: September 20, 2011
• First Posted (Estimate): September 21, 2011

Study Record Updates

• Last Update Posted (Actual): August 16, 2018
• Last Update Submitted That Met QC Criteria: July 19, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: pharmacokinetics; pharmacodynamics; sulforaphane; broccoli sprout; glucoraphanin; carcinogens, environment
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Carcinogenesis
• Other Study ID Numbers: IRB00003494; 5P01ES006052 (U.S. NIH Grant/Contract)