Trial Outcomes & Findings for Broccoli Sprout Dose Response: Bioavailability and Effects of Air Pollutants (NCT NCT02656420)
NCT ID: NCT02656420
Last Updated: 2019-05-01
Results Overview
Urinary excretion of broccoli-derived sulforaphane metabolites: sulforaphane-mercapturic acid. The metabolites were measured all 20 of the sequential 12-hour urine collections from each participant over the 10-day intervention period. Data from each individual were summed to provide a single "per 24-hours" value for each participant.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
170 participants
Primary outcome timeframe
10 days
Results posted on
2019-05-01
Participant Flow
Participant milestones
| Measure |
Placebo
Beverage (100 mL) containing pineapple juice, lime juice and water. Nightly for 10 days.
Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo.
|
High Dose Broccoli Sprout
Beverage (100 mL) containing glucoraphanin-rich (600 micromole) and sulforaphane-rich (40 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.
Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo.
|
Medium Dose Broccoli Sprout
Beverage (100 mL) containing glucoraphanin-rich (300 micromole) and sulforaphane-rich (20 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.
Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo.
|
Low Dose Broccoli Sprout
Beverage (100 mL) containing glucoraphanin-rich (120 micromole) and sulforaphane-rich (8 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.
Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
55
|
25
|
35
|
55
|
|
Overall Study
COMPLETED
|
55
|
24
|
35
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Broccoli Sprout Dose Response: Bioavailability and Effects of Air Pollutants
Baseline characteristics by cohort
| Measure |
Placebo
n=55 Participants
Beverage (100 mL) containing pineapple juice, lime juice and water. Nightly for 10 days.
Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo.
|
High Dose Broccoli Sprout
n=25 Participants
Beverage (100 mL) containing glucoraphanin-rich (600 micromole) and sulforaphane-rich (40 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.
Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo.
|
Medium Dose Broccoli Sprout
n=35 Participants
Beverage (100 mL) containing glucoraphanin-rich (300 micromole) and sulforaphane-rich (20 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.
Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo.
|
Low Dose Broccoli Sprout
n=55 Participants
Beverage (100 mL) containing glucoraphanin-rich (120 micromole) and sulforaphane-rich (8 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.
Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo.
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
55 Participants
n=483 Participants
|
170 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
56 years
n=93 Participants
|
59 years
n=4 Participants
|
58 years
n=27 Participants
|
60 years
n=483 Participants
|
58 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
43 Participants
n=483 Participants
|
127 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
43 Participants
n=36 Participants
|
|
Region of Enrollment
China
|
55 participants
n=93 Participants
|
25 participants
n=4 Participants
|
35 participants
n=27 Participants
|
55 participants
n=483 Participants
|
170 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 10 daysPopulation: Placebo arm samples were not analyzed f because no sulforaphane was administered to this group. Historically, background levels from dietary sources in this population are very low compared to active intervention levels. In addition, one participant in the High Dose Broccoli Sprout arm did not complete the full protocol and was not included.
Urinary excretion of broccoli-derived sulforaphane metabolites: sulforaphane-mercapturic acid. The metabolites were measured all 20 of the sequential 12-hour urine collections from each participant over the 10-day intervention period. Data from each individual were summed to provide a single "per 24-hours" value for each participant.
Outcome measures
| Measure |
Placebo
Beverage (100 mL) containing pineapple juice, lime juice and water. Nightly for 10 days.
Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo.
|
High Dose Broccoli Sprout
n=24 Participants
Beverage (100 mL) containing glucoraphanin-rich (600 micromole) and sulforaphane-rich (40 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.
Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo.
|
Medium Dose Broccoli Sprout
n=35 Participants
Beverage (100 mL) containing glucoraphanin-rich (300 micromole) and sulforaphane-rich (20 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.
Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo.
|
Low Dose Broccoli Sprout
n=55 Participants
Beverage (100 mL) containing glucoraphanin-rich (120 micromole) and sulforaphane-rich (8 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.
Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo.
|
|---|---|---|---|---|
|
Sulforaphane Bioavailability Measured in Sequential 12-Hour Urine Samples
|
—
|
24.8 micromoles/24 hours
Interval 16.8 to 33.5
|
11.0 micromoles/24 hours
Interval 8.4 to 13.2
|
4.3 micromoles/24 hours
Interval 3.6 to 5.2
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Due to irreversible failure of the mass spectrometer used in this analysis, not all urine samples were evaluated for SPMA levels. Only individuals for whom all 10 samples were collected and analyzed are included in this summary (132/169).
Benzene-mercapturic acid (SPMA) excretion was measured in the sequential overnight 12-hour urine samples collected across the 10-day study period. Data from each individual were summed and averaged to provide a single "per 12-hours" value for each participant.
Outcome measures
| Measure |
Placebo
n=42 Participants
Beverage (100 mL) containing pineapple juice, lime juice and water. Nightly for 10 days.
Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo.
|
High Dose Broccoli Sprout
n=44 Participants
Beverage (100 mL) containing glucoraphanin-rich (600 micromole) and sulforaphane-rich (40 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.
Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo.
|
Medium Dose Broccoli Sprout
n=26 Participants
Beverage (100 mL) containing glucoraphanin-rich (300 micromole) and sulforaphane-rich (20 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.
Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo.
|
Low Dose Broccoli Sprout
n=20 Participants
Beverage (100 mL) containing glucoraphanin-rich (120 micromole) and sulforaphane-rich (8 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.
Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo.
|
|---|---|---|---|---|
|
Modulation of Air Pollutant Excretion in Sequential Overnight 12-Hour Urine Samples
|
0.67 nmol SPMA excreted/ 12 hours
Interval 0.43 to 0.97
|
0.62 nmol SPMA excreted/ 12 hours
Interval 0.39 to 1.02
|
0.74 nmol SPMA excreted/ 12 hours
Interval 0.62 to 1.18
|
1.09 nmol SPMA excreted/ 12 hours
Interval 0.67 to 1.64
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Dose Broccoli Sprout
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Medium Dose Broccoli Sprout
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Dose Broccoli Sprout
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place