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Broccoli Sprout Dose Response: Bioavailability and Effects of Air Pollutants

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ClinicalTrials.gov Identifier: NCT02656420
Recruitment Status : Completed
First Posted : January 15, 2016
Results First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Collaborators:
Qidong Liver Cancer Institute
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Environmental Carcinogenesis
Interventions Drug: Broccoli Sprout-derived Beverage
Drug: Placebos
Enrollment 170
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo High Dose Broccoli Sprout Medium Dose Broccoli Sprout Low Dose Broccoli Sprout
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: Overall Study
Started 55 25 35 55
Completed 55 24 35 55
Not Completed 0 1 0 0
Arm/Group Title Placebo High Dose Broccoli Sprout Medium Dose Broccoli Sprout Low Dose Broccoli Sprout Total
Hide Arm/Group Description

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.

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 55 25 35 55 170
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 25 participants 35 participants 55 participants 170 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
55
 100.0%
25
 100.0%
35
 100.0%
55
 100.0%
170
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 55 participants 25 participants 35 participants 55 participants 170 participants
56
(53 to 61)
59
(56 to 62)
58
(50 to 64)
60
(53 to 63)
58
(50 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 25 participants 35 participants 55 participants 170 participants
Female
38
  69.1%
18
  72.0%
28
  80.0%
43
  78.2%
127
  74.7%
Male
17
  30.9%
7
  28.0%
7
  20.0%
12
  21.8%
43
  25.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 55 participants 25 participants 35 participants 55 participants 170 participants
55 25 35 55 170
1.Primary Outcome
Title Sulforaphane Bioavailability Measured in Sequential 12-Hour Urine Samples
Hide Description 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.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo High Dose Broccoli Sprout Medium Dose Broccoli Sprout Low Dose Broccoli Sprout
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 0 24 35 55
Geometric Mean (Inter-Quartile Range)
Unit of Measure: micromoles/24 hours
24.8
(16.8 to 33.5)
11.0
(8.4 to 13.2)
4.3
(3.6 to 5.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Dose Broccoli Sprout, Medium Dose Broccoli Sprout, Low Dose Broccoli Sprout
Comments The null hypothesis is that the urinary sulforaphane levels are equal across treatment arms. Sulforaphane metabolite levels were measured daily for 10 days in each arm.
Type of Statistical Test Equivalence
Comments Statistical significance of the treatment effect (p < 0.01) for the lower doses compared to the high dose as the reference.
Statistical Test of Hypothesis P-Value <0.001
Comments Using a linear mixed effects model with random intercepts and slope, SF level (in the log scale) was regressed on categorical treatment group (medium dose and low dose; high as the reference) as well as day (continuous variable).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.73
Confidence Interval (2-Sided) 95%
-1.89 to -1.57
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.090
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Modulation of Air Pollutant Excretion in Sequential Overnight 12-Hour Urine Samples
Hide Description 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.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Placebo Low Dose Broccoli Sprout Medium Dose Broccoli Sprout High Dose Broccoli Sprout
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 42 44 26 20
Geometric Mean (Inter-Quartile Range)
Unit of Measure: nmol SPMA excreted/ 12 hours
0.67
(0.43 to 0.97)
0.62
(0.39 to 1.02)
0.74
(0.62 to 1.18)
1.09
(0.67 to 1.64)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Low Dose Broccoli Sprout, Medium Dose Broccoli Sprout, High Dose Broccoli Sprout
Comments All broccoli sprout arms were compared with the placebo arm.
Type of Statistical Test Superiority
Comments To summarize first 12-hour SPMA levels over the study course by participant, the SPMA geometric mean (in the log scale) for each individual was calculated and used as the outcome. Treatment arms (placebo, fifth, half and full doses) were independent (categorical) variables in a linear regression model with placebo as the reference.
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 63.2
Confidence Interval (2-Sided) 95%
10.6 to 140.9
Estimation Comments This Estimation Parameter was based on the comparison between the full dose group and the placebo group.
Time Frame Daily during the course of the 10-day study and again 1 week after completion of the study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo High Dose Broccoli Sprout Medium Dose Broccoli Sprout Low Dose Broccoli Sprout
Hide Arm/Group Description

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.

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.

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.

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.

All-Cause Mortality
Placebo High Dose Broccoli Sprout Medium Dose Broccoli Sprout Low Dose Broccoli Sprout
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo High Dose Broccoli Sprout Medium Dose Broccoli Sprout Low Dose Broccoli Sprout
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/25 (0.00%)   0/35 (0.00%)   0/55 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo High Dose Broccoli Sprout Medium Dose Broccoli Sprout Low Dose Broccoli Sprout
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/25 (0.00%)   0/35 (0.00%)   0/55 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Thomas W. Kensler
Organization: JHSPH
Phone: 410-955-1292
EMail: tkensle1@jhu.edu
Layout table for additonal information
Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT02656420    
Other Study ID Numbers: IRB00006734
R01CA190610 ( U.S. NIH Grant/Contract )
First Submitted: January 5, 2016
First Posted: January 15, 2016
Results First Submitted: July 19, 2018
Results First Posted: May 1, 2019
Last Update Posted: May 1, 2019