Back to resultsBroccoli Sprout Intervention in Qidong, P.R. China
Primary Purpose
Environmental Carcinogenesis
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Broccoli Sprout Extract Beverage
placebo beverage
Sponsored by
About this trial
This is an interventional prevention trial for Environmental Carcinogenesis focused on measuring glucoraphanin, sulforaphane, pharmacokinetics, pharmacodynamics, broccoli sprout, carcinogens, environment
Eligibility 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
Sites / Locations
- Qidong Liver Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Broccoli Sprout Extract Beverage
Placebo beverage
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01437501
First Posted
September 15, 2011
Last Updated
July 19, 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
1. Study Identification
Unique Protocol Identification Number
NCT01437501
Brief Title
Broccoli Sprout Intervention in Qidong, P.R. China
Official Title
Broccoli Sprout Intervention in Qidong, P.R. China
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the 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
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Environmental Carcinogenesis
Keywords
glucoraphanin, sulforaphane, pharmacokinetics, pharmacodynamics, broccoli sprout, carcinogens, environment
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
291 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Broccoli Sprout Extract Beverage
Arm Type
Experimental
Arm Title
Placebo beverage
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Broccoli Sprout Extract Beverage
Intervention Description
Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
Intervention Type
Drug
Intervention Name(s)
placebo beverage
Intervention Description
100 mL of dilute pineapple and lime juice daily for 84 days.
Primary Outcome Measure Information:
Title
Effect of Treatment on Levels of Air Toxics Mercapturic Acids Over Intervention Period
Description
Urinary excretion of benzene mercapturic acid (S-PMA) in 12 hour overnight void at 12 weeks
Time Frame
Endpoints were assessed on urine samples collected at the end of the intervention on week 12.
Secondary Outcome Measure Information:
Title
Levels of Sulforaphane and Its Metabolites at the End of Intervention Period (After 84 Daily Doses)
Description
Micromoles of urinary sulforaphane metabolites excreted over 24 hours after consuming the 84th dose.
Time Frame
Endpoints assessed on urine samples collected at the end of the intervention (day 84 [week 12])
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas W Kensler, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qidong Liver Cancer Institute
City
Qidong
State/Province
Jiangsu
ZIP/Postal Code
226200
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
16284385
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. doi: 10.1158/1055-9965.EPI-05-0368.
Results Reference
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PubMed Identifier
21372038
Citation
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.
Results Reference
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Broccoli Sprout Intervention in Qidong, P.R. China
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