Broccoli Sprout Intervention in Qidong, P.R. China

Environmental Carcinogenesis Clinical Trial

Official title:

Broccoli Sprout Intervention in Qidong, P.R. China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01437501
• Other study ID #: IRB00003494
• Secondary ID: 5P01ES006052
• Status: Completed
• Phase: Phase 2
• Start date: October 2011
• Est. completion date: January 2012

Study information

• Verified date: July 2018
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinogenesis
• Environmental Carcinogenesis

Intervention

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 beverage
100 mL of dilute pineapple and lime juice daily for 84 days.

Locations

Country	Name	City	State
China	Qidong Liver Cancer Institute	Qidong	Jiangsu

Sponsors (6)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Johns Hopkins University, National Institute of Environmental Health Sciences (NIEHS), Qidong Liver Cancer Institute, University of Minnesota - Clinical and Translational Science Institute, University of Pittsburgh

Country where clinical trial is conducted

China, 

References & Publications (2)

Egner PA, Chen JG, Wang JB, Wu Y, Sun Y, Lu JH, Zhu J, Zhang YH, Chen YS, Friesen MD, Jacobson LP, Muñoz 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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])