Broccoli Sprout Intervention in Qidong, P.R. China

NCT01437501 | Completed Phase 2 Results

• 2 other identifiers: IRB000034945P01ES006052
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 1

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.

Conditions

Environmental Carcinogenesis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Levels of Sulforaphane and Its Metabolites at the End of Intervention Period (After 84 Daily Doses)

  Endpoints assessed on urine samples collected at the end of the intervention (day 84 [week 12])

Study Arms (2)

Broccoli Sprout Extract Beverage

EXPERIMENTAL

Drug: Broccoli Sprout Extract Beverage

Placebo beverage

PLACEBO COMPARATOR

Drug: placebo beverage

Interventions

Broccoli Sprout Extract Beverage DRUG

Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.

Broccoli Sprout Extract Beverage

placebo beverage DRUG

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

Placebo beverage

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• personal history of cancer except for non-melanoma skin cancer
• use of prescribed medications
• hepatomegaly by clinical exam
• for women, a positive pregnancy test

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Johns Hopkins University: collaborator
• National Institute of Environmental Health Sciences (NIEHS): collaborator
• Qidong Liver Cancer Institute: collaborator
• University of Pittsburgh: collaborator
• University of Minnesota: collaborator

Study Sites (1)

Qidong Liver Cancer Institute

Qidong, Jiangsu, 226200, China

Location

Related Publications (2)

• 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.

  PMID: 16284385 BACKGROUND

• 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.

  PMID: 21372038 BACKGROUND

Results Point of Contact

• Title: Thomas W. Kensler, PhD
• Organization: Johns Hopkins Bloomberg School of Public Health

tkensler@jhsph.edu

410-955-1292

Study Officials

• Thomas W Kensler, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: September 21, 2011
• Study Start: October 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: August 16, 2018
• Results First Posted: September 23, 2013

Record last verified: 2018-07

Locations

CN (1)