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Broccoli Sprout Extracts Trial to See if NRF2 is Enhanced by Sulforaphane Treatment in Patients With COPD (BEST)

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: NCT01335971
Recruitment Status : Completed
First Posted : April 15, 2011
Results First Posted : May 19, 2017
Last Update Posted : May 19, 2017
Sponsor:
Collaborators:
Temple University
State University of New York at Buffalo
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition COPD
Interventions Drug: Sulforaphane 25
Dietary Supplement: Sulforaphane 150
Other: Placebo
Enrollment 89
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Sulforaphane 25 Sulforaphane 150
Hide Arm/Group Description

Microcrystalline cellulose

Placebo: Microcrystalline cellulose once daily by mouth

25 micromoles (4.4 mg) sulforaphane daily by mouth

Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth

150 micromoles (26.6 mg) sulforaphane daily by mouth

Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth

Period Title: Overall Study
Started 31 29 29
Completed 29 28 28
Not Completed 2 1 1
Reason Not Completed
Withdrawal by Subject             1             0             0
Did not complete bronchoscopy             1             1             1
Arm/Group Title Placebo Sulforaphane 25 Sulforaphane 150 Total
Hide Arm/Group Description

Microcrystalline cellulose

Placebo: Microcrystalline cellulose once daily by mouth

25 micromoles (4.4 mg) sulforaphane daily by mouth

Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth

150 micromoles (26.6 mg) sulforaphane daily by mouth

Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth

Total of all reporting groups
Overall Number of Baseline Participants 31 29 29 89
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 29 participants 89 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
  71.0%
24
  82.8%
19
  65.5%
65
  73.0%
>=65 years
9
  29.0%
5
  17.2%
10
  34.5%
24
  27.0%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 31 participants 29 participants 29 participants 89 participants
59
(52 to 67)
59
(54 to 65)
56
(52 to 62)
58
(54 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 29 participants 89 participants
Female
15
  48.4%
12
  41.4%
8
  27.6%
35
  39.3%
Male
16
  51.6%
17
  58.6%
21
  72.4%
54
  60.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 29 participants 29 participants 89 participants
31 29 29 89
Chronic obstructive pulmonary disease (COPD) characteristics  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 29 participants 89 participants
10 or more pack years of smoking history 30 29 29 88
Smoke cigarettes now 20 16 18 54
Smoke 10 or more cigarettes a day now 10 9 10 29
COPD exacerbation in last 12 months 5 7 7 19
Post bronchodilator FEV1   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Percent predicted
Number Analyzed 31 participants 29 participants 29 participants 89 participants
61
(54 to 70)
54
(50 to 65)
65
(55 to 72)
61
(53 to 70)
[1]
Measure Description: Forced expiratory volume in 1 second (FEV1) after administration of bronchodilator
Post bronchodilator FEV1/FVC ratio   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Ratio
Number Analyzed 31 participants 29 participants 29 participants 89 participants
0.56
(0.51 to 0.63)
0.52
(0.47 to 0.59)
0.57
(0.50 to 0.63)
0.56
(0.48 to 0.62)
[1]
Measure Description: Ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) after bronchodilation
Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  mL/mmHg/min
Number Analyzed 31 participants 29 participants 29 participants 89 participants
14.8
(11.8 to 19.5)
15.7
(12.1 to 19.3)
16.3
(12.3 to 21.4)
15.7
(12.1 to 20.9)
[1]
Measure Description: DLCO: Diffusing capacity of the lungs for carbon monoxide measured by the single breath technique in accordance with American Thoracic Society standards
Pulse oximetry (SpO2)  
Median (Inter-Quartile Range)
Unit of measure:  Percentage of oxyhemoglobin
Number Analyzed 31 participants 29 participants 29 participants 89 participants
95
(94 to 97)
96
(95 to 97)
96
(94 to 97)
96
(94 to 97)
Pulmonary function measures   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Liters
Number Analyzed 31 participants 29 participants 29 participants 89 participants
Total lung capacity
6.0
(4.7 to 7.3)
5.5
(4.9 to 6.8)
6.3
(5.7 to 7.0)
6.0
(5.0 to 7.2)
Slow vital capacity
3.1
(2.4 to 4.1)
3.0
(2.8 to 3.7)
3.7
(3.1 to 4.4)
3.3
(2.7 to 4.1)
Forced residual capacity
3.6
(3.1 to 4.5)
3.6
(3.0 to 4.1)
3.4
(3.0 to 3.9)
3.5
(3.0 to 4.2)
Residual volume
2.6
(2.5 to 3.4)
2.6
(2.2 to 3.5)
2.7
(2.3 to 2.9)
2.6
(2.2 to 3.2)
[1]
Measure Description: Values were determined using either helium dilution or plethysmography methods, depending on equipment available at study sites. Lung volumes were measured in accordance with local hospital procedures.
Use of respiratory medications in prior 2 weeks  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 29 participants 89 participants
Short-acting beta-agonist 22 21 18 61
Long-acting beta-agonist 2 1 2 5
Long-acting beta-agonist & inhaled corticosteroid 14 13 13 40
Long-acting anticholinergic bronchodilator 7 9 10 26
Medical Research Council Dyspnea Score   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 31 participants 29 participants 29 participants 89 participants
2
(1 to 3)
2
(2 to 3)
2
(1 to 3)
2
(1 to 3)
[1]
Measure Description: Minimum score 1, maximum score 5. Higher values represent a worse outcome.
St Georges Respiratory Questionnaire   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 31 participants 29 participants 29 participants 89 participants
Total score
43
(24 to 58)
47
(27 to 56)
39
(24 to 54)
40
(26 to 56)
Symptoms score
58
(32 to 70)
55
(43 to 68)
50
(31 to 57)
52
(36 to 68)
Activity score
54
(30 to 74)
60
(47 to 74)
50
(41 to 73)
55
(36 to 74)
Impacts score
27
(17 to 44)
34
(15 to 46)
26
(13 to 42)
28
(15 to 44)
[1]
Measure Description:

Scales, ranges, and descriptors:

All scores are expressed as a percentage of overall impairment where 100 is the worst possible health status and 0 is the best possible health status.

Total score (all items) summarizes the impact of the disease on overall health status Symptoms score (Q1-8) looks at the effect of respiratory symptoms, their frequency and severity.

Activity score (Q11-17, 37-45) measures activities causing or limited by breathlessness Impacts score (Q18-36, 46-52) covers a range of aspects re: social functioning and psychological disturbances resulting from airways disease

1.Primary Outcome
Title Change From Baseline in Alveolar Macrophage Expression of Nrf2 and Associated Genes at 4 Weeks
Hide Description The first primary design variable is the change from baseline in nuclear factor erythroid 2 like 2 (Nrf2) expression in alveolar macrophages (AM) at 4 weeks by analysing Nrf2 protein and expression of a panel of Nrf2 regulated genes.Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed based on number of individuals with alveolar macrophage samples in which assays could be successfully performed. Assays failed for two participants in the placebo group, one in the 25 micromole group, and one in the 150 micromole group.
Arm/Group Title Placebo Sulforaphane 25 Sulforaphane 150
Hide Arm/Group Description:

Microcrystalline cellulose

Placebo: Microcrystalline cellulose once daily by mouth

25 micromoles (4.4 mg) sulforaphane daily by mouth

Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth

150 micromoles (26.6 mg) sulforaphane daily by mouth

Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth

Overall Number of Participants Analyzed 27 27 27
Median (Inter-Quartile Range)
Unit of Measure: fold change
NQ01
0.80
(0.53 to 1.09)
1.03
(0.56 to 1.60)
0.94
(0.59 to 1.72)
HO1
0.90
(0.69 to 1.34)
0.98
(0.83 to 1.31)
1.06
(0.68 to 1.74)
AKR1C1
0.81
(0.46 to 1.27)
1.13
(0.38 to 1.99)
0.71
(0.56 to 1.57)
AKR1C3
1.03
(0.76 to 1.37)
1.02
(0.67 to 1.31)
0.87
(0.40 to 1.32)
Nrf2
1.14
(0.79 to 1.52)
1.05
(0.87 to 1.47)
1.13
(0.74 to 1.28)
Keap1
0.94
(0.66 to 1.17)
0.99
(0.82 to 1.11)
1.06
(0.59 to 1.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sulforaphane 25, Sulforaphane 150
Comments Applies to gene expression of NAD(P)H Quinone Dehydrogenase 1 (NQ01) in alveolar macrophages
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Sulforaphane 25, Sulforaphane 150
Comments Applies to gene expression of Heme Oxygenase 1 (HO1) in alveolar macrophages
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Sulforaphane 25, Sulforaphane 150
Comments Applies to gene expression of Aldo-Keto Reductase Family 1 Member C1 (AKR1C1) in alveolar macrophages
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.75
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Sulforaphane 25, Sulforaphane 150
Comments Applies to gene expression of Aldo-Keto Reductase Family 1 Member C3 (AKR1C3) in alveolar macrophages
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Sulforaphane 25, Sulforaphane 150
Comments Applies to gene expression of nuclear factor erythroid 2 like 2 (Nrf2) in alveolar macrophages
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Sulforaphane 25, Sulforaphane 150
Comments Applies to gene expression of Kelch Like ECH Associated Protein 1 (Keap1) in alveolar macrophages
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Bronchial Epithelial Cell Expression of Nrf2 at 4 Weeks
Hide Description The second primary design variable is the change from baseline in nuclear factor erythroid 2 like 2 (Nrf2) expression in bronchial epithelial cells (BEC) at 4 weeks by analysing Nrf2 protein. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed based on number of individuals with bronchial epithelial samples in which assays could be successfully performed. Assays failed for one participant in the placebo group and one in the 25 micromole group..
Arm/Group Title Placebo Sulforaphane 25 Sulforaphane 150
Hide Arm/Group Description:

Microcrystalline cellulose

Placebo: Microcrystalline cellulose once daily by mouth

25 micromoles (4.4 mg) sulforaphane daily by mouth

Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth

150 micromoles (26.6 mg) sulforaphane daily by mouth

Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth

Overall Number of Participants Analyzed 28 27 28
Median (Inter-Quartile Range)
Unit of Measure: fold change
1.09
(0.88 to 1.30)
1.06
(0.92 to 1.28)
1.06
(0.76 to 1.31)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sulforaphane 25, Sulforaphane 150
Comments Applies to gene expression of Nrf2 in bronchial epithelial cells
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline in Bronchial Epithelial Cell Expression of NQ01 and Keap1 at 4 Weeks
Hide Description The third primary design variable is the change from baseline in NAD(P)H Quinone Dehydrogenase 1 (NQ01) and Kelch Like ECH Associated Protein 1 (Keap1) expression in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed based on number of individuals with bronchial epithelial samples in which assays could be successfully performed. Assays failed for two participants in the placebo group and one in the 150 micromole group.
Arm/Group Title Placebo Sulforaphane 25 Sulforaphane 150
Hide Arm/Group Description:

Microcrystalline cellulose

Placebo: Microcrystalline cellulose once daily by mouth

25 micromoles (4.4 mg) sulforaphane daily by mouth

Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth

150 micromoles (26.6 mg) sulforaphane daily by mouth

Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth

Overall Number of Participants Analyzed 27 28 27
Median (Inter-Quartile Range)
Unit of Measure: fold change
NQ01
1.09
(0.83 to 1.50)
1.12
(0.89 to 1.53)
0.96
(0.65 to 1.41)
KEAP1
1.12
(0.71 to 1.54)
1.39
(0.99 to 2.24)
0.87
(0.58 to 1.10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sulforaphane 25, Sulforaphane 150
Comments Applies to gene expression of NAD(P)H Quinone Dehydrogenase 1 (NQ01) in bronchial epithelial cells
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Sulforaphane 25, Sulforaphane 150
Comments Applies to gene expression of Kelch Like ECH Associated Protein 1 (Keap1) in bronchial epithelial cells
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
4.Primary Outcome
Title Change From Baseline in Bronchial Epithelial Cell Expression of HO1 at 4 Weeks
Hide Description The fourth primary design variable is the change from baseline in expression of Heme Oxygenase 1 (HO1) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed based on number of individuals with bronchial epithelial samples in which assays could be successfully performed. Assays failed for one participant in the placebo group.
Arm/Group Title Placebo Sulforaphane 25 Sulforaphane 150
Hide Arm/Group Description:

Microcrystalline cellulose

Placebo: Microcrystalline cellulose once daily by mouth

25 micromoles (4.4 mg) sulforaphane daily by mouth

Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth

150 micromoles (26.6 mg) sulforaphane daily by mouth

Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth

Overall Number of Participants Analyzed 28 28 28
Median (Inter-Quartile Range)
Unit of Measure: fold change
1.05
(0.60 to 1.23)
1.12
(0.82 to 1.67)
0.93
(0.62 to 1.45)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sulforaphane 25, Sulforaphane 150
Comments Applies to gene expression of Heme Oxygenase 1 (HO1) in bronchial epithelial cells
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
5.Primary Outcome
Title Change From Baseline in Bronchial Epithelial Cell Expression of AKR1C1 at 4 Weeks
Hide Description The fifth primary design variable is the change from baseline in expression of Aldo-Keto Reductase Family 1 Member C1 (AKR1C1) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed based on number of individuals with alveolar macrophage samples in which assays could be successfully performed. Assays failed for two participants in the placebo group and two in the 150 micromole group.
Arm/Group Title Placebo Sulforaphane 25 Sulforaphane 150
Hide Arm/Group Description:

Microcrystalline cellulose

Placebo: Microcrystalline cellulose once daily by mouth

25 micromoles (4.4 mg) sulforaphane daily by mouth

Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth

150 micromoles (26.6 mg) sulforaphane daily by mouth

Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth

Overall Number of Participants Analyzed 27 28 27
Median (Inter-Quartile Range)
Unit of Measure: fold change
1.45
(0.84 to 1.98)
1.08
(0.85 to 2.14)
0.79
(0.53 to 1.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sulforaphane 25, Sulforaphane 150
Comments Applies to gene expression of Aldo-Keto Reductase Family 1 Member C1 (AKR1C1) in bronchial epithelial cells.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
6.Primary Outcome
Title Change From Baseline in Bronchial Epithelial Cell Expression of AKR1C3 at 4 Weeks
Hide Description The sixth primary design variable is the change from baseline in expression of Aldo-Keto Reductase Family 1 Member C3 (AKR1C3) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed based on number of individuals with bronchial epithelial samples in which assays could be successfully performed. Assays failed for two participants in the placebo group, one participant in the 25 micromole group, and one participant in the 150 micromole group.
Arm/Group Title Placebo Sulforaphane 25 Sulforaphane 150
Hide Arm/Group Description:

Microcrystalline cellulose

Placebo: Microcrystalline cellulose once daily by mouth

25 micromoles (4.4 mg) sulforaphane daily by mouth

Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth

150 micromoles (26.6 mg) sulforaphane daily by mouth

Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth

Overall Number of Participants Analyzed 27 27 27
Median (Inter-Quartile Range)
Unit of Measure: fold change
1.10
(0.74 to 1.62)
1.38
(0.91 to 2.64)
0.87
(0.50 to 1.68)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sulforaphane 25, Sulforaphane 150
Comments Applies to gene expression of Aldo-Keto Reductase Family 1 Member C3 (AKR1C3) in bronchial epithelial cells.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
7.Secondary Outcome
Title Fold-change in Isoprostane Concentrations (Follow-up to Baseline)
Hide Description Isoprostane, an oxidant stress indicator, was measured in expired breath condensate at baseline and 4 weeks.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed based on number of individuals with expired breath condensate samples in which testing could be successfully performed. Samples were missing for two participants in the 25 micromole group and one participant in the 150 micromole group.
Arm/Group Title Placebo Sulforaphane 25 Sulforaphane 150
Hide Arm/Group Description:

Microcrystalline cellulose

Placebo: Microcrystalline cellulose once daily by mouth

25 micromoles (4.4 mg) sulforaphane daily by mouth

Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth

150 micromoles (26.6 mg) sulforaphane daily by mouth

Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth

Overall Number of Participants Analyzed 30 27 28
Median (Inter-Quartile Range)
Unit of Measure: fold change
1.18
(0.42 to 1.79)
0.83
(0.24 to 1.41)
0.64
(0.29 to 1.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sulforaphane 25, Sulforaphane 150
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
8.Secondary Outcome
Title Fold-change in Serum Inflammatory Marker Concentrations (Follow-up to Baseline)
Hide Description Inflammatory markers were measured in serum samples derived from venipuncture at baseline and 4 weeks in the serum of the participants of the trial.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed is based on number of participants that had plasma samples available. Samples were missing for one participant in the 25 micromole group.
Arm/Group Title Placebo Sulforaphane 25 Sulforaphane 150
Hide Arm/Group Description:

Microcrystalline cellulose

Placebo: Microcrystalline cellulose once daily by mouth

25 micromoles (4.4 mg) sulforaphane daily by mouth

Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth

150 micromoles (26.6 mg) sulforaphane daily by mouth

Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth

Overall Number of Participants Analyzed 30 28 29
Median (Inter-Quartile Range)
Unit of Measure: fold change
C-reactive protein (mg/L)
0.99
(0.86 to 1.22)
0.90
(0.69 to 1.06)
1.01
(0.72 to 1.22)
Interleukin-6 (pg/mL)
0.75
(0.65 to 1.19)
0.90
(0.76 to 1.08)
1.12
(0.88 to 1.37)
Interleukin-8 (pg/mL)
1.06
(0.86 to 1.32)
1.04
(0.87 to 1.17)
1.03
(0.83 to 1.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sulforaphane 25, Sulforaphane 150
Comments Applies to C-reactive protein concentration
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Sulforaphane 25, Sulforaphane 150
Comments Applies to Interleukin-6 concentration
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Sulforaphane 25, Sulforaphane 150
Comments Applies to Interleukin-8 concentration
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
9.Secondary Outcome
Title Fold-change in Inflammatory Marker Concentrations in Bronchial Alveolar Lavage (Follow-up to Baseline) by Treatment Group
Hide Description Inflammatory markers were measured in bronchial alveolar lavage samples at baseline and 4 weeks in the participants of this trial who had bronchoalveolar lavage samples obtained.Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed is based on number of participants that had bronchial alveolar lavage samples available. Samples were missing for two participants in the placebo group.
Arm/Group Title Placebo Sulforaphane 25 Sulforaphane 150
Hide Arm/Group Description:

Microcrystalline cellulose

Placebo: Microcrystalline cellulose once daily by mouth

25 micromoles (4.4 mg) sulforaphane daily by mouth

Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth

150 micromoles (26.6 mg) sulforaphane daily by mouth

Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth

Overall Number of Participants Analyzed 27 28 28
Median (Inter-Quartile Range)
Unit of Measure: fold change
Interleukin-8 (pg/mg)
1.22
(0.68 to 2.75)
0.94
(0.52 to 2.22)
1.11
(0.42 to 2.54)
Secretory leukoprotease inhibitor (pg/mg)
1.51
(0.83 to 1.90)
1.09
(0.85 to 1.49)
1.12
(0.65 to 1.51)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sulforaphane 25, Sulforaphane 150
Comments Applies to interleukin-8 results
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Sulforaphane 25, Sulforaphane 150
Comments Applies to secretory leukoprotease inhibitor results
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
10.Secondary Outcome
Title Fold-change in Plasma Inflammatory Marker Concentrations (Follow-up to Baseline)
Hide Description Inflammatory markers were measured in plasma at baseline and 4 weeks. Thiobarbituric acid reactive substances were measured in nmol malondialdehyde (MDA)/mL.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed is based on number of participants that had plasma samples available. Samples were missing for one participant in the 25 micromole group.
Arm/Group Title Placebo Sulforaphane 25 Sulforaphane 150
Hide Arm/Group Description:

Microcrystalline cellulose

Placebo: Microcrystalline cellulose once daily by mouth

25 micromoles (4.4 mg) sulforaphane daily by mouth

Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth

150 micromoles (26.6 mg) sulforaphane daily by mouth

Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth

Overall Number of Participants Analyzed 30 28 29
Median (Inter-Quartile Range)
Unit of Measure: fold change
Isoprostane (ng/mg)
0.89
(0.55 to 1.22)
0.90
(0.63 to 1.74)
0.88
(0.55 to 1.37)
Thiobarbituric acid reactive substances
0.96
(0.77 to 1.19)
1.05
(0.88 to 1.17)
1.06
(0.84 to 1.27)
Total antioxidants (mM Trolox equivalents/L)
0.97
(0.92 to 1.03)
0.92
(0.85 to 1.03)
0.97
(0.90 to 1.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sulforaphane 25, Sulforaphane 150
Comments Applies to isoprostane results.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Sulforaphane 25, Sulforaphane 150
Comments Applies to thiobarbituric acid reactive substances results.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Sulforaphane 25, Sulforaphane 150
Comments Applies to total antioxidants results.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Assessed via study questionnaires.
 
Arm/Group Title Placebo Sulforaphane 25 Sulforaphane 150
Hide Arm/Group Description

Microcrystalline cellulose

Placebo: Microcrystalline cellulose once daily by mouth

25 micromoles (4.4 mg) sulforaphane daily by mouth

Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth

150 micromoles (26.6 mg) sulforaphane daily by mouth

Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth

All-Cause Mortality
Placebo Sulforaphane 25 Sulforaphane 150
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo Sulforaphane 25 Sulforaphane 150
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/31 (0.00%)      2/29 (6.90%)      1/29 (3.45%)    
Hepatobiliary disorders       
Cholecystitis   0/31 (0.00%)  0 1/29 (3.45%)  1 0/29 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
COPD exacerbation   0/31 (0.00%)  0 1/29 (3.45%)  1 0/29 (0.00%)  0
Pneumonia   0/31 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Sulforaphane 25 Sulforaphane 150
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/31 (48.39%)      21/29 (72.41%)      18/29 (62.07%)    
Gastrointestinal disorders       
Nausea   1/31 (3.23%)  1 2/29 (6.90%)  2 6/29 (20.69%)  6
Vomiting   0/31 (0.00%)  0 1/29 (3.45%)  1 0/29 (0.00%)  0
Poor appetite   1/31 (3.23%)  1 2/29 (6.90%)  2 2/29 (6.90%)  2
Bad taste in mouth   2/31 (6.45%)  2 7/29 (24.14%)  7 9/29 (31.03%)  9
Heartburn   1/31 (3.23%)  1 6/29 (20.69%)  6 7/29 (24.14%)  7
Bloating/gas   5/31 (16.13%)  5 7/29 (24.14%)  7 6/29 (20.69%)  6
Diarrhea   2/31 (6.45%)  2 3/29 (10.34%)  3 2/29 (6.90%)  2
Abdominal discomfort   1/31 (3.23%)  1 3/29 (10.34%)  3 6/29 (20.69%)  6
Constipation   0/31 (0.00%)  0 1/29 (3.45%)  1 1/29 (3.45%)  1
General disorders       
Headache   2/31 (6.45%)  2 2/29 (6.90%)  2 1/29 (3.45%)  1
Fatigue   3/31 (9.68%)  3 5/29 (17.24%)  5 2/29 (6.90%)  2
Musculoskeletal and connective tissue disorders       
Leg pain   0/31 (0.00%)  0 1/29 (3.45%)  1 1/29 (3.45%)  1
Respiratory, thoracic and mediastinal disorders       
Respiratory infection   1/31 (3.23%)  1 1/29 (3.45%)  1 1/29 (3.45%)  1
Chest pain   0/31 (0.00%)  0 2/29 (6.90%)  2 0/29 (0.00%)  0
Increased phlegm   1/31 (3.23%)  1 0/29 (0.00%)  0 1/29 (3.45%)  1
Shortness of breath   0/31 (0.00%)  0 1/29 (3.45%)  1 1/29 (3.45%)  1
Skin and subcutaneous tissue disorders       
Skin rash   1/31 (3.23%)  1 2/29 (6.90%)  2 1/29 (3.45%)  1
Indicates events were collected by systematic assessment
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: Alexis Rea
Organization: Johns Hopkins University School of Medicine
Phone: (443) 287-8496
EMail: area5@jhu.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01335971    
Obsolete Identifiers: NCT01318603
Other Study ID Numbers: 1U01HL105569 ( U.S. NIH Grant/Contract )
RFA-HL-10-003 ( Other Identifier: NHLBI )
First Submitted: April 8, 2011
First Posted: April 15, 2011
Results First Submitted: August 25, 2016
Results First Posted: May 19, 2017
Last Update Posted: May 19, 2017