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| ID | Type | Description | Link |
|---|---|---|---|
| 5P01ES006052 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| National Institute of Environmental Health Sciences (NIEHS) | NIH |
| Qidong Liver Cancer Institute | OTHER |
| University of Pittsburgh |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Broccoli Sprout Extract Beverage | Experimental |
| |
| Placebo beverage | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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]) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas W Kensler, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qidong Liver Cancer Institute | Qidong | Jiangsu | 226200 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16284385 | Background | 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. | |
| 21372038 |
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1205 Individuals were recruited from HeHe Township in Qidong, PRC for eligibility screening at 3 medical clinics within the township in September 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Broccoli Sprout Extract Beverage | 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. |
| FG001 | Placebo Beverage | placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Broccoli Sprout Extract Beverage | 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. |
| BG001 | Placebo Beverage |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Analyses were conducted on all urine samples provided by study participants at week 12. | Posted | Median | Inter-Quartile Range | pmol/mg creatinine | Endpoints were assessed on urine samples collected at the end of the intervention on week 12. |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Broccoli Sprout Extract Beverage | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| light vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas W. Kensler, PhD | Johns Hopkins Bloomberg School of Public Health | 410-955-1292 | tkensler@jhsph.edu |
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| OTHER |
| University of Minnesota | OTHER |
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| placebo beverage | Drug | 100 mL of dilute pineapple and lime juice daily for 84 days. |
|
| 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. |
placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days. |
|
|
| 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. | Posted | Median | Inter-Quartile Range | micromoles | Endpoints assessed on urine samples collected at the end of the intervention (day 84 [week 12]) |
|
|
|
| 0 |
| 148 |
| 6 |
| 148 |
| EG001 | Placebo Beverage | placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days. | 0 | 143 | 4 | 143 |
| indigestion | Gastrointestinal disorders | Non-systematic Assessment |
|
| taste | Gastrointestinal disorders | Non-systematic Assessment | participants disliked taste, worried about participation, withdrew from study |
|
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