Broccoli Sprout Intervention in Qidong, P.R. China

• ClinicalTrials.gov Identifier: NCT01437501
• Recruitment Status: Completed
• First Posted: September 21, 2011
• Results First Posted: September 23, 2013
• Last Update Posted: August 16, 2018
• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: Johns Hopkins University; National Institute of Environmental Health Sciences (NIEHS); Qidong Liver Cancer Institute; University of Pittsburgh; University of Minnesota
• Information provided by (Responsible Party): Johns Hopkins Bloomberg School of Public Health

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Environmental Carcinogenesis	Drug: Broccoli Sprout Extract Beverage; Drug: placebo beverage	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 291 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Broccoli Sprout Intervention in Qidong, P.R. China
• Study Start Date: October 2011
• Actual Primary Completion Date: January 2012
• Actual Study Completion Date: January 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

China, Jiangsu

Qidong Liver Cancer Institute

Qidong, Jiangsu, China, 226200

Sponsors and Collaborators

Johns Hopkins Bloomberg School of Public Health

Johns Hopkins University

National Institute of Environmental Health Sciences (NIEHS)

Qidong Liver Cancer Institute

University of Pittsburgh

University of Minnesota

Investigators

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

More Information

Publications:

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.

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.

• Responsible Party: Johns Hopkins Bloomberg School of Public Health
• ClinicalTrials.gov Identifier: NCT01437501
• Other Study ID Numbers: IRB00003494; 5P01ES006052 ( U.S. NIH Grant/Contract )
• First Posted: September 21, 2011
• Results First Posted: September 23, 2013
• Last Update Posted: August 16, 2018
• Last Verified: July 2018

Keywords provided by Johns Hopkins Bloomberg School of Public Health:

glucoraphanin; sulforaphane; pharmacokinetics; pharmacodynamics; broccoli sprout; carcinogens, environment

Additional relevant MeSH terms:

Carcinogenesis; Neoplastic Processes; Neoplasms; Pathologic Processes