A Phase 2 interventional study of Broccoli Sprout Extract Beverage and placebo beverage in Environmental Carcinogenesis, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in China. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-16.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Phase 2, Interventional, and Prevention
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.
39 studies on the registry are indexed under Carcinogenesis; 10 are open to participants now.
This study's enrollment of 291 is above the median of 70 across 14 interventional studies indexed under Carcinogenesis.
Browse Carcinogenesis studies →Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 364 studies on the registry; 41 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Exclusion Criteria:
Drug: Broccoli Sprout Extract Beverage
Drug: placebo 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.
100 mL of dilute pineapple and lime juice daily for 84 days.
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
Time frame: Endpoints were assessed on urine samples collected at the end of the intervention on week 12.
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.
Time frame: Endpoints assessed on urine samples collected at the end of the intervention (day 84 [week 12])
1205 Individuals were recruited from HeHe Township in Qidong, PRC for eligibility screening at 3 medical clinics within the township in September 2011.
| Milestone | Broccoli Sprout Extract Beverage | Placebo Beverage |
|---|---|---|
| Started | 148 | 143 |
| Completed | 135 | 132 |
| Not completed | 13 | 11 |
Urinary excretion of benzene mercapturic acid (S-PMA) in 12 hour overnight void at 12 weeks
| pmol/mg creatinine | Broccoli Sprout Extract Beverage | Placebo Beverage |
|---|---|---|
| Effect of Treatment on Levels of Air Toxics Mercapturic Acids Over Intervention Period | 1.700 (1.235 to 2.386) | 1.065 (0.686 to 1.826) |
Micromoles of urinary sulforaphane metabolites excreted over 24 hours after consuming the 84th dose.
| micromoles | Placebo Beverage | Broccoli Sprout Extract Beverage |
|---|---|---|
| Levels of Sulforaphane and Its Metabolites at the End of Intervention Period (After 84 Daily Doses) | 1 (1 to 1) | 62 (44 to 91) |
Collected over 3 months. Non-serious events are listed at a 0.3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Broccoli Sprout Extract Beverage | — | 0/148 (0%) | 6/148 (4.1%) |
| Placebo Beverage | — | 0/143 (0%) | 4/143 (2.8%) |
| Event | Broccoli Sprout Extract Beverage | Placebo Beverage |
|---|---|---|
| indigestionGastrointestinal disorders | 4/148 | 2/143 |
| tasteGastrointestinal disorders | 1/148 | 2/143 |
| light vomitingGastrointestinal disorders | 1/148 | 0/143 |
| Age, Categorical(Participants) | Broccoli Sprout Extract Beverage | Placebo Beverage | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 148 | 143 | 291 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Broccoli Sprout Extract Beverage | Placebo Beverage | Total |
|---|---|---|---|
| Mean | 51.1 ± 9.4 | 52.6 ± 7.7 | 51.8 ± 8.7 |
| Sex: Female, Male(Participants) | Broccoli Sprout Extract Beverage | Placebo Beverage | Total |
|---|---|---|---|
| Female | 118 | 111 | 229 |
| Male | 30 | 32 | 62 |
| Region of Enrollment(participants) | Broccoli Sprout Extract Beverage | Placebo Beverage | Total |
|---|---|---|---|
| China | 148 | 143 | 291 |
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Johns Hopkins Bloomberg School of Public Health