Trial Outcomes & Findings for Broccoli Sprout Intervention in Qidong, P.R. China (NCT NCT01437501)
NCT ID: NCT01437501
Last Updated: 2018-08-16
Results Overview
Urinary excretion of benzene mercapturic acid (S-PMA) in 12 hour overnight void at 12 weeks
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
291 participants
Primary outcome timeframe
Endpoints were assessed on urine samples collected at the end of the intervention on week 12.
Results posted on
2018-08-16
Participant Flow
1205 Individuals were recruited from HeHe Township in Qidong, PRC for eligibility screening at 3 medical clinics within the township in September 2011.
Participant milestones
| Measure |
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.
|
Placebo Beverage
placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
|
|---|---|---|
|
Overall Study
STARTED
|
148
|
143
|
|
Overall Study
COMPLETED
|
135
|
132
|
|
Overall Study
NOT COMPLETED
|
13
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Broccoli Sprout Intervention in Qidong, P.R. China
Baseline characteristics by cohort
| Measure |
Broccoli Sprout Extract Beverage
n=148 Participants
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
n=143 Participants
placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
|
Total
n=291 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
148 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
291 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
51.1 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
52.6 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
51.8 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
148 participants
n=5 Participants
|
143 participants
n=7 Participants
|
291 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Endpoints were assessed on urine samples collected at the end of the intervention on week 12.Population: Analyses were conducted on all urine samples provided by study participants at week 12.
Urinary excretion of benzene mercapturic acid (S-PMA) in 12 hour overnight void at 12 weeks
Outcome measures
| Measure |
Broccoli Sprout Extract Beverage
n=135 Participants
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
n=132 Participants
placebo beverage : 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
|
1.700 pmol/mg creatinine
Interval 1.235 to 2.386
|
1.065 pmol/mg creatinine
Interval 0.686 to 1.826
|
SECONDARY outcome
Timeframe: Endpoints assessed on urine samples collected at the end of the intervention (day 84 [week 12])Micromoles of urinary sulforaphane metabolites excreted over 24 hours after consuming the 84th dose.
Outcome measures
| Measure |
Broccoli Sprout Extract Beverage
n=132 Participants
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
n=135 Participants
placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
|
|---|---|---|
|
Levels of Sulforaphane and Its Metabolites at the End of Intervention Period (After 84 Daily Doses)
|
1 micromoles
Interval 1.0 to 1.0
|
62 micromoles
Interval 44.0 to 91.0
|
Adverse Events
Broccoli Sprout Extract Beverage
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Beverage
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Broccoli Sprout Extract Beverage
n=148 participants at risk
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
n=143 participants at risk
placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
|
|---|---|---|
|
Gastrointestinal disorders
light vomiting
|
0.68%
1/148 • Number of events 1 • 3 months
|
0.00%
0/143 • 3 months
|
|
Gastrointestinal disorders
indigestion
|
2.7%
4/148 • Number of events 4 • 3 months
|
1.4%
2/143 • Number of events 2 • 3 months
|
|
Gastrointestinal disorders
taste
|
0.68%
1/148 • Number of events 1 • 3 months
|
1.4%
2/143 • Number of events 2 • 3 months
|
Additional Information
Thomas W. Kensler, PhD
Johns Hopkins Bloomberg School of Public Health
Phone: 410-955-1292
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place