Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sulforaphane for the Treatment of Young Men With Autism Spectrum Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02909959
Recruitment Status : Completed
First Posted : September 21, 2016
Results First Posted : May 15, 2020
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
North Carolina Translational and Clinical Sciences Institute
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Autism Spectrum Disorder
Autistic Disorder
Neurodevelopmental Disorder
Childhood Developmental Disorders, Pervasive
Interventions Drug: Sulforaphane
Drug: Placebo
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Period Title: Overall Study
Started 24 24
Completed 24 24
Not Completed 0 0
Arm/Group Title Sulforaphane Placebo Total
Hide Arm/Group Description

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm. Total of all reporting groups
Overall Number of Baseline Participants 24 24 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
<=18 years
16
  66.7%
15
  62.5%
31
  64.6%
Between 18 and 65 years
8
  33.3%
9
  37.5%
17
  35.4%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 24 participants 48 participants
16.8  (3.9) 17.7  (4.1) 17.2  (4.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
24
 100.0%
24
 100.0%
48
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
Hispanic or Latino
1
   4.2%
2
   8.3%
3
   6.3%
Not Hispanic or Latino
23
  95.8%
22
  91.7%
45
  93.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   8.3%
0
   0.0%
2
   4.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   4.2%
2
   8.3%
3
   6.3%
White
19
  79.2%
21
  87.5%
40
  83.3%
More than one race
2
   8.3%
1
   4.2%
3
   6.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 24 participants 24 participants 48 participants
24
 100.0%
24
 100.0%
48
 100.0%
1.Primary Outcome
Title Social Responsiveness Scale-2 (SRS-2) Total Score at Baseline
Hide Description The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: T-score
75.6  (7.4) 72.6  (4.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sulforaphane, Placebo
Comments The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.
Type of Statistical Test Equivalence
Comments Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.
Statistical Test of Hypothesis P-Value 0.331
Comments The test was considered statistically significant if the p-value < 0.05.
Method Mixed Models Analysis
Comments Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.96
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.03
Estimation Comments This analysis compares LS Mean Sulforaphane - LS Mean Placebo.
2.Primary Outcome
Title Social Responsiveness Scale-2 (SRS-2) Total Score at Week 4
Hide Description The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: T-score
74.1  (7.4) 74.1  (4.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sulforaphane, Placebo
Comments The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.
Type of Statistical Test Equivalence
Comments Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.
Statistical Test of Hypothesis P-Value 0.98
Comments The test was considered statistically significant if the p-value < 0.05.
Method Mixed Models Analysis
Comments Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.99
Estimation Comments This analysis compares LS Mean Sulforaphane - LS Mean Placebo.
3.Primary Outcome
Title Social Responsiveness Scale-2 (SRS-2) Total Score at Week 8
Hide Description The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: T-score
73.7  (7.4) 74.5  (4.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sulforaphane, Placebo
Comments The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.
Type of Statistical Test Equivalence
Comments Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.
Statistical Test of Hypothesis P-Value 0.797
Comments The test was considered statistically significant if the p-value < 0.05.
Method Mixed Models Analysis
Comments Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.774
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.99
Estimation Comments This analysis compares LS Mean Sulforaphane - LS Mean Placebo.
4.Primary Outcome
Title Social Responsiveness Scale-2 (SRS-2) Total Score at Week 12
Hide Description The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: T-score
75.3  (7.4) 72.9  (4.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sulforaphane, Placebo
Comments The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.
Type of Statistical Test Equivalence
Comments Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.
Statistical Test of Hypothesis P-Value 0.442
Comments The test was considered statistically significant if the p-value < 0.05.
Method Mixed Models Analysis
Comments Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.01
Estimation Comments This analysis compares LS Mean Sulforaphane - LS Mean Placebo.
5.Primary Outcome
Title Social Responsiveness Scale-2 (SRS-2) Total Score at Week 16
Hide Description The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: T-score
75.5  (7.4) 72.7  (4.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sulforaphane, Placebo
Comments The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.
Type of Statistical Test Equivalence
Comments Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.
Statistical Test of Hypothesis P-Value 0.373
Comments The test was considered statistically significant if the p-value < 0.05.
Method Mixed Models Analysis
Comments Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.72
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.05
Estimation Comments This analysis compares LS Mean Sulforaphane - LS Mean Placebo.
6.Secondary Outcome
Title Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Awareness)
Hide Description

The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Social Awareness subscale measures a participant's ability to recognize social cues. This subscale comprises 8 items with scores ranging from 1 to 4 for a total range of scores from 8 to 32. A higher score represents a greater ability to recognize social cues.

Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

Time Frame Baseline, Week 4, Week 8, Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Baseline 10.9  (2.5) 10.9  (1.6)
Week 4 10.5  (2.5) 11.3  (1.6)
Week 8 10.6  (2.5) 11.3  (1.6)
Week 12 10.8  (2.5) 11.0  (1.6)
Week 16 10.7  (2.5) 11.2  (1.6)
7.Secondary Outcome
Title Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Cognition)
Hide Description The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Social Cognition subscale measures a participant's ability to interpret social behavior. This subscale comprises 12 items with scores ranging from 1 to 4 for a total range of scores from 12 to 48. A higher score represents a greater ability to interpret social behaviors. Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame Baseline, Week 4, Week 8, Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Baseline 19.1  (4.1) 17.4  (2.6)
Week 4 18.3  (4.1) 18.2  (2.6)
Week 8 18.2  (4.1) 18.4  (2.6)
Week 12 18.7  (4.1) 17.9  (2.6)
Week 16 18.7  (4.1) 17.9  (2.6)
8.Secondary Outcome
Title Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Communication)
Hide Description The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Social Communication subscale measures a participant's ability to assess reciprocal communication in social situations. This subscale comprises 22 items with scores ranging from 1 to 4 for a total range of scores from 22 to 88. A higher score represents a greater ability to assess reciprocal communication. Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame Baseline, Week 4, Week 8, Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Baseline 34.0  (6.6) 32.0  (4.1)
Week 4 32.4  (6.6) 33.6  (4.1)
Week 8 32.6  (6.6) 33.5  (4.1)
Week 12 34.1  (6.6) 32.0  (4.1)
Week 16 34.4  (6.6) 31.7  (4.1)
9.Secondary Outcome
Title Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Motivation)
Hide Description The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Social Motivation subscale measures the degree to which a participant is motivated to participate in social interactions. This subscale comprises 11 items with scores ranging from 1 to 4 for a total range of scores from 11 to 44. A higher score represents a greater motivation to participate in social interaction. Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame Baseline, Week 4, Week 8, Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Baseline 15.5  (4.1) 14.7  (2.5)
Week 4 14.8  (4.1) 15.4  (2.5)
Week 8 14.6  (4.1) 15.6  (2.5)
Week 12 15.5  (4.1) 14.7  (2.5)
Week 16 15.9  (4.1) 14.3  (2.5)
10.Secondary Outcome
Title Social Responsiveness Scale-2 (SRS-2) Subscale Score (Restricted Interests/Repetitive Behaviors)
Hide Description The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Restricted Interests/Repetitive Behaviors subscale assesses the participant's level of stereotypy and circumscribed interests. This subscale comprises 12 items with scores ranging from 1 to 4 for a total range of scores from 12 to 48. A higher score represents a greater level of stereotypy and circumscribed interests. Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame Baseline, Week 4, Week 8, Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Baseline 18.6  (4.5) 17.6  (2.8)
Week 4 18.1  (4.5) 18.2  (2.8)
Week 8 17.7  (4.5) 18.5  (2.8)
Week 12 18.7  (4.5) 17.5  (2.8)
Week 16 18.5  (4.5) 17.7  (2.8)
11.Secondary Outcome
Title Aberrant Behavior Checklist (ABC) Subscale Score (Social Withdrawal)
Hide Description The Aberrant Behavior Checklist (ABC) is a 58-item caregiver questionnaire developed to assess medication effects in individuals with developmental disorders and includes 5 distinct subscales of behavioral symptoms. The ABC-Social Withdrawal subscale assesses the participant's level social withdrawal. This subscale comprises 16 items with scores ranging from 0 to 3 for a total range of scores from 0 to 48. A higher score represents a greater level of social withdrawal. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame Baseline, Week 4, Week 8, Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Baseline 8.7  (5.1) 8.3  (3.2)
Week 4 8.2  (5.1) 8.8  (3.2)
Week 8 8.2  (5.1) 8.8  (3.2)
Week 12 9.0  (5.1) 8.1  (3.2)
Week 16 9.5  (5.1) 7.5  (3.2)
12.Secondary Outcome
Title Aberrant Behavior Checklist (ABC) Subscale Scores (Hyperactivity)
Hide Description The Aberrant Behavior Checklist (ABC) is a 58-item caregiver questionnaire developed to assess medication effects in individuals with developmental disorders and includes 5 distinct subscales of behavioral symptoms. The ABC-Hyperactivity subscale assesses the participant's level hyperactivity and non-compliance. This subscale comprises 16 items with scores ranging from 0 to 3 for a total range of scores from 0 to 48. A higher score represents a greater level of hyperactivity/non-compliance. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame Baseline, Week 4, Week 8, Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Baseline 14.3  (5.7) 10.8  (3.6)
Week 4 13.0  (5.7) 12.1  (3.6)
Week 8 12.6  (5.7) 12.5  (3.6)
Week 12 13.7  (5.7) 11.3  (3.6)
Week 16 13.6  (5.7) 11.5  (3.6)
13.Secondary Outcome
Title Aberrant Behavior Checklist (ABC) Subscale Score (Inappropriate Speech)
Hide Description The Aberrant Behavior Checklist (ABC) is a 58-item caregiver questionnaire developed to assess medication effects in individuals with developmental disorders and includes 5 distinct subscales of behavioral symptoms. The ABC-Inappropriate Speech subscale assesses the participant's use of inappropriate speech. This subscale comprises 4 items with scores ranging from 0 to 3 for a total range of scores from 0 to 12. A higher score represents a greater use of inappropriate speech. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame Baseline, Week 4, Week 8, Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Baseline 3.4  (1.7) 2.8  (1.1)
Week 4 3.2  (1.7) 2.9  (1.1)
Week 8 3.0  (1.7) 3.1  (1.1)
Week 12 3.3  (1.7) 2.9  (1.1)
Week 16 3.5  (1.7) 2.6  (1.1)
14.Secondary Outcome
Title Aberrant Behavior Checklist (ABC) Subscale Score (Stereotypy)
Hide Description The Aberrant Behavior Checklist (ABC) is a 58-item caregiver questionnaire developed to assess medication effects in individuals with developmental disorders and includes 5 distinct subscales of behavioral symptoms. The ABC-Stereotypy subscale assesses the participant's level of stereotypic behavior. This subscale comprises 7 items with scores ranging from 0 to 3 for a total range of scores from 0 to 21. A higher score represents a greater level of stereotypic behavior. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame Baseline, Week 4, Week 8, Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Baseline 1.3  (3.2) 2.2  (2.0)
Week 4 1.1  (3.2) 2.4  (2.0)
Week 8 1.0  (3.2) 2.5  (2.0)
Week 12 1.3  (3.2) 2.2  (2.0)
Week 16 1.6  (3.2) 1.6  (2.0)
15.Secondary Outcome
Title Aberrant Behavior Checklist (ABC) Subscale Score (Irritability)
Hide Description The Aberrant Behavior Checklist (ABC) is a 58-item caregiver questionnaire developed to assess medication effects in individuals with developmental disorders and includes 5 distinct subscales of behavioral symptoms. The ABC-Irritability subscale assesses the participant's level of irritability. This subscale comprises 15 items with scores ranging from 0 to 3 for a total range of scores from 0 to 45. A higher score represents a greater level of irritability. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame Baseline, Week 4, Week 8, Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Baseline 9.6  (5.1) 8.3  (3.2)
Week 4 9.4  (5.1) 8.6  (3.2)
Week 8 9.7  (5.1) 8.3  (3.2)
Week 12 9.7  (5.1) 8.3  (3.2)
Week 16 9.8  (5.1) 8.1  (3.2)
16.Secondary Outcome
Title Clinical Global Impression-Severity (CGI-S) Score
Hide Description The CGI-Severity (CGI-S) scale is a 7-point, clinician-rated scale providing an overall assessment of patient functioning relative to other patients with a similar diagnosis (1=not at all ill to 7=severely ill). A higher score indicates a higher level of severity of psychopathology. This scale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame Baseline, Week 4, Week 8, Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 4.74  (0.6) 4.56  (0.3)
Week 4 4.70  (0.6) 4.60  (0.3)
Week 8 4.71  (0.6) 4.58  (0.3)
Week 12 4.72  (0.6) 4.58  (0.3)
Week 16 4.70  (0.6) 4.60  (0.3)
17.Secondary Outcome
Title Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score of Much Improved or Very Much Improved
Hide Description The clinician-rated CGI-Improvement (CGI-I) scale rates overall improvement or worsening of illness (ie, ASD) relative to baseline. The CGI-Improvement (CGI-I) scale rates overall improvement or worsening of illness (ie, ASD) relative to baseline. Possible scores on this scale range from 1-6 with the following assigned values: 1 = "Very Much Improved"; 2 = "Much Improved; 3 = "Minimally improved"; 4 = "No change"; 5 = "Minimally worse"; 6= "Much worse." A higher score indicates worsening of illness (ie, ASD), whereas a lower score indicates improvement of illness. This scale was measured at Week 4, Week 8, Week 12, and Week 16. In this measure, the number of participants in each treatment arm determined by the study physician to be "Much Improved" or "Very Much Improved" (indicative of meaningful clinical improvement) were counted.
Time Frame Week 4, Week 8, Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 Very Much Improved or Much Improved
3
  12.5%
1
   4.2%
No Improvement to Very Much Worse
21
  87.5%
23
  95.8%
Week 8 Very Much Improved or Much Improved
4
  16.7%
2
   8.3%
No Improvement to Very Much Worse
20
  83.3%
22
  91.7%
Week 12 Very Much Improved or Much Improved
3
  12.5%
4
  16.7%
No Improvement to Very Much Worse
21
  87.5%
20
  83.3%
Week 16 Very Much Improved or Much Improved
0
   0.0%
1
   4.2%
No Improvement to Very Much Worse
24
 100.0%
23
  95.8%
18.Secondary Outcome
Title Repetitive Behavior Scale-Revised (RBSR) Total Score
Hide Description The RBS-R is a 43-item, informant-based questionnaire designed to quantify a range of restricted, repetitive behaviors (RRB) observed in ASD. Scores for each item range from 0 = "Behavior does not occur" to 3 = "Behavior occurs and is a severe problem". Thus the total range is 0 to 129. A higher score indicates a higher breadth of repetitive behaviors. This scale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame Baseline, Week 4, Week 8, Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Baseline 23.0  (14.0) 22.3  (8.7)
Week 4 21.7  (14.0) 23.5  (8.7)
Week 8 23.3  (14.0) 22.0  (8.7)
Week 12 23.3  (14.0) 22.0  (8.7)
Week 16 24.2  (14.0) 21.0  (8.7)
19.Secondary Outcome
Title Mean Red Blood Cell Value
Hide Description This measure assesses the red blood cell value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: 10^6 cells/microliter
Baseline 5.0  (0.3) 5.1  (0.3)
Week 12 5.1  (0.3) 5.0  (0.3)
20.Secondary Outcome
Title Mean White Blood Cell Value
Hide Description This measure assesses the white blood cell value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: 10^3 cells/microliter
Baseline 6.3  (2.3) 6.5  (2.2)
Week 12 6.0  (1.8) 6.9  (2.2)
21.Secondary Outcome
Title Mean Hemoglobin Value
Hide Description This measure assesses the hemoglobin value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: g/dL
Baseline 14.8  (1.4) 15.0  (1.1)
Week 12 15.0  (1.2) 14.5  (1.0)
22.Secondary Outcome
Title Mean Hematocrit Value
Hide Description This measure assesses the hematocrit value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: percentage of volume of whole blood
Baseline 43.8  (3.5) 44.4  (2.9)
Week 12 44.4  (3.0) 43.2  (2.8)
23.Secondary Outcome
Title Mean Corpuscular Volume Value
Hide Description This measure assesses the mean corpuscular volume value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: femtoliter
Baseline 87.3  (3.2) 86.8  (4.6)
Week 12 87.8  (3.1) 86.6  (3.8)
24.Secondary Outcome
Title Mean Corpuscular Hemoglobin Value
Hide Description This measure assesses the mean corpuscular hemoglobin value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: picogram
Baseline 29.4  (1.7) 29.3  (1.8)
Week 12 29.7  (1.2) 29.2  (1.8)
25.Secondary Outcome
Title Mean Corpuscular Hemoglobin Concentration Value
Hide Description This measure assesses the mean corpuscular hemoglobin concentration value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: g/dL
Baseline 33.8  (1.0) 33.9  (1.1)
Week 12 33.8  (0.9) 33.7  (0.9)
26.Secondary Outcome
Title Mean Red Blood Cell Distribution Width Value
Hide Description This measure assesses the red blood cell distribution width value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: % of volume of whole blood
Baseline 13.6  (0.8) 13.7  (1.0)
Week 12 13.6  (0.9) 13.6  (1.0)
27.Secondary Outcome
Title Mean Platelets Value
Hide Description This measure assesses the platelets value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: 10^3 cells/microliter
Baseline 253.8  (74.7) 286.0  (67.5)
Week 12 246.0  (69.5) 279.3  (57.7)
28.Secondary Outcome
Title Mean Absolute Neutrophils Value
Hide Description This measure assesses the absolute neutrophils value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: 10^3 cells/microliter
Baseline 3.5  (2.0) 3.7  (1.8)
Week 12 3.3  (1.5) 6.3  (11.0)
29.Secondary Outcome
Title Mean Absolute Lymphocytes Value
Hide Description This measure assesses the absolute lymphocytes value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: 10^3 cells/microliter
Baseline 2.1  (0.6) 2.1  (0.5)
Week 12 1.9  (0.6) 3.5  (6.9)
30.Secondary Outcome
Title Mean Absolute Monocytes Value
Hide Description This measure assesses the absolute monocytes value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: 10^3 cells/microliter
Baseline 0.5  (0.2) 0.6  (0.2)
Week 12 0.5  (0.1) 0.9  (1.6)
31.Secondary Outcome
Title Mean Absolute Eosinophils Value
Hide Description This measure assesses the absolute eosinophils value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: 10^6 cells/microliter
Baseline 0.2  (0.1) 0.1  (0.1)
Week 12 0.2  (0.1) 0.2  (0.2)
32.Secondary Outcome
Title Mean Absolute Basophils Value
Hide Description This measure assesses the absolute basophils value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: 10^3 cells/microliter
Baseline 0.013  (0.034) 0.013  (0.034)
Week 12 0.004  (0.021) 0.009  (0.029)
33.Secondary Outcome
Title Mean Serum Chemistries (Sodium)
Hide Description This measure assesses the change in the patient's sodium levels. This serum chemistry level was measured at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: millimol/liter
Baseline 140.6  (2.3) 141.0  (2.0)
Week 12 141.8  (2.5) 141.3  (1.8)
34.Secondary Outcome
Title Mean Serum Chemistries (Potassium)
Hide Description This measure assesses the change in the patient's potassium levels. This serum chemistry level was measured at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline 4.4  (0.4) 4.5  (0.4)
Week 12 4.7  (0.6) 4.5  (0.4)
35.Secondary Outcome
Title Mean Serum Chemistries (Chloride)
Hide Description This measure assesses the change in the patient's chloride levels. This serum chemistry level was measured at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline 100.1  (2.1) 99.6  (1.9)
Week 12 100.1  (2.3) 100.7  (2.1)
36.Secondary Outcome
Title Mean Serum Chemistries (Bicarbonate)
Hide Description This measure assesses the change in the patient's bicarbonate levels. This serum chemistry level was measured at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline 22.8  (3.0) 22.3  (1.5)
Week 12 23.1  (2.7) 22.8  (2.4)
37.Secondary Outcome
Title Mean Serum Chemistries (Blood Urea Nitrogen)
Hide Description This measure assesses the change in the patient's blood urea nitrogen levels. This serum chemistry level was measured at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 13.0  (4.8) 11.4  (2.8)
Week 12 13.3  (4.3) 11.6  (3.5)
38.Secondary Outcome
Title Mean Serum Chemistries (Creatinine)
Hide Description This measure assesses the change in the patient's creatinine levels. This serum chemistry level was measured at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 0.8  (0.1) 0.8  (0.2)
Week 12 0.8  (0.1) 0.8  (0.2)
39.Secondary Outcome
Title Mean Serum Chemistries (Glucose)
Hide Description This measure assesses the change in the patient's glucose levels. This serum chemistry level was measured at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 90.9  (13.0) 91.1  (12.6)
Week 12 87.0  (18.3) 86.3  (13.5)
40.Secondary Outcome
Title Mean Liver Function Tests Values (Alanine Transaminase)
Hide Description This measure assesses the change in the patient's level of liver function through measure of alanine transaminase (ALT). This liver function test value was measured at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: IU/L
Baseline 22.1  (16.7) 26.0  (18.0)
Week 12 29.6  (40.7) 20.7  (10.8)
41.Secondary Outcome
Title Mean Liver Function Tests Values (Aspartate Transaminase)
Hide Description This measure assesses the change in the patient's level of liver function through measure of aspartate transaminase. This liver function test value was measured at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: IU/L
Baseline 22.3  (10.2) 21.9  (5.8)
Week 12 25.2  (10.6) 19.8  (5.1)
42.Secondary Outcome
Title Mean Liver Function Tests Values (Total Bilirubin)
Hide Description This measure assesses the change in the patient's level of liver function through measure of total bilirubin. This liver function test value was measured at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 0.5  (0.3) 0.4  (0.3)
Week 12 0.5  (0.2) 0.5  (0.4)
43.Secondary Outcome
Title Mean Value of Thyroid Stimulating Hormone (TSH)
Hide Description This measure assesses the change in the patient's value of thyroid stimulating hormone. This hormone value was measured at Baseline and Week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: milli-international units/ microliter
Baseline 2.3  (1.2) 2.2  (1.2)
Week 12 2.3  (1.2) 1.8  (1.1)
44.Secondary Outcome
Title Least Squares Mean of Vital Signs (Weight)
Hide Description This measure assesses the change in the patient's weight (lbs). This vital sign was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame Baseline, Week 4, Week 8, Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: pounds
Baseline 147.1  (28.1) 148.3  (17.4)
Week 4 147.2  (28.1) 148.2  (17.4)
Week 8 146.8  (28.1) 148.6  (17.4)
Week 12 146.9  (28.1) 148.6  (17.4)
Week 16 146.8  (28.1) 148.6  (17.4)
45.Secondary Outcome
Title Least Squares Mean of Vital Signs (Height)
Hide Description This measure assesses the change in the patient's height (centimeters). This vital sign was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame Baseline, Week 4, Week 8, Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: centimeters
Baseline 173.9  (6.5) 173.3  (4.0)
Week 4 173.9  (6.5) 173.3  (4.0)
Week 8 173.9  (6.5) 173.3  (4.0)
Week 12 173.9  (6.5) 173.3  (4.0)
Week 16 173.9  (6.5) 173.3  (4.0)
46.Secondary Outcome
Title Least Squares Mean of Vital Signs (Blood Pressure)
Hide Description This measure assesses the change in the patient's systolic and diastolic blood pressure. This vital sign was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame Baseline, Week 4, Week 8, Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
Baseline Systolic 115.2  (6.6) 116.7  (4.1)
Baseline Diastolic 69.8  (4.5) 70.6  (2.8)
Week 4 Systolic 116.3  (6.6) 115.5  (4.1)
Week 4 Diastolic 69.7  (4.5) 70.7  (2.8)
Week 8 Systolic 116.4  (6.6) 115.4  (4.1)
Week 8 Diastolic 69.6  (4.5) 70.8  (2.8)
Week 12 Systolic 116.2  (6.6) 115.7  (4.1)
Week 12 Diastolic 71.0  (4.5) 69.4  (2.8)
Week 16 Systolic 116.2  (6.6) 115.7  (4.1)
Week 16 Diastolic 71.1  (4.5) 69.3  (2.8)
47.Secondary Outcome
Title Least Squares Mean of Vital Signs (Heart Rate)
Hide Description This measure assesses the change in the patient's heart rate (beats per minute). This vital sign was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame Baseline, Week 4, Week 8, Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: Beats per Minute
Baseline 86.1  (8.6) 87.5  (5.4)
Week 4 88.0  (8.6) 85.6  (5.4)
Week 8 87.8  (8.6) 85.7  (5.4)
Week 12 86.5  (8.6) 87.0  (5.4)
Week 16 90.0  (8.6) 83.5  (5.4)
Time Frame Adverse events were assessed from baseline to week 16 (a total of 16 weeks).
Adverse Event Reporting Description Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.
 
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description

Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb

Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
All-Cause Mortality
Sulforaphane Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%) 
Hide Serious Adverse Events
Sulforaphane Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sulforaphane Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   14/24 (58.33%)   14/24 (58.33%) 
Gastrointestinal disorders     
Appetite Decrease   0/24 (0.00%)  1/24 (4.17%) 
Stomach Discomfort   1/24 (4.17%)  0/24 (0.00%) 
General disorders     
Fatigue   0/24 (0.00%)  1/24 (4.17%) 
Nervous system disorders     
Headache   1/24 (4.17%)  1/24 (4.17%) 
Psychiatric disorders     
Aggression   2/24 (8.33%)  2/24 (8.33%) 
Anxiety   1/24 (4.17%)  0/24 (0.00%) 
Difficulty Falling Asleep   1/24 (4.17%)  0/24 (0.00%) 
Irritability   3/24 (12.50%)  4/24 (16.67%) 
Restlessness   2/24 (8.33%)  1/24 (4.17%) 
Sedation   0/24 (0.00%)  1/24 (4.17%) 
Self-injurious Behavior   0/24 (0.00%)  2/24 (8.33%) 
Stereotypy   1/24 (4.17%)  1/24 (4.17%) 
Suicidal Ideation   1/24 (4.17%)  0/24 (0.00%) 
Skin and subcutaneous tissue disorders     
Localized Rash   1/24 (4.17%)  0/24 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Laura Politte, MD
Organization: University of North Carolina at Chapel Hill
Phone: 919-350-1726
EMail: lpolitte@wakemed.org
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02909959    
Other Study ID Numbers: 16-2059
5KL2TR001109-05 ( U.S. NIH Grant/Contract )
First Submitted: September 7, 2016
First Posted: September 21, 2016
Results First Submitted: April 28, 2020
Results First Posted: May 15, 2020
Last Update Posted: June 4, 2020