Trial Outcomes & Findings for Broccoli Sprout Extracts Trial to See if NRF2 is Enhanced by Sulforaphane Treatment in Patients With COPD (NCT NCT01335971)
NCT ID: NCT01335971
Last Updated: 2017-05-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
89 participants
Primary outcome timeframe
Baseline and 4 weeks
Results posted on
2017-05-19
Participant Flow
Participant milestones
| Measure |
Placebo
Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth
|
Sulforaphane 25
25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth
|
Sulforaphane 150
150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
29
|
|
Overall Study
COMPLETED
|
29
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth
|
Sulforaphane 25
25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth
|
Sulforaphane 150
150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Did not complete bronchoscopy
|
1
|
1
|
1
|
Baseline Characteristics
Broccoli Sprout Extracts Trial to See if NRF2 is Enhanced by Sulforaphane Treatment in Patients With COPD
Baseline characteristics by cohort
| Measure |
Placebo
n=31 Participants
Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth
|
Sulforaphane 25
n=29 Participants
25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth
|
Sulforaphane 150
n=29 Participants
150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
65 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
|
Age, Continuous
|
59 years
n=93 Participants
|
59 years
n=4 Participants
|
56 years
n=27 Participants
|
58 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
35 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
54 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=93 Participants
|
29 participants
n=4 Participants
|
29 participants
n=27 Participants
|
89 participants
n=483 Participants
|
|
Chronic obstructive pulmonary disease (COPD) characteristics
10 or more pack years of smoking history
|
30 participants
n=93 Participants
|
29 participants
n=4 Participants
|
29 participants
n=27 Participants
|
88 participants
n=483 Participants
|
|
Chronic obstructive pulmonary disease (COPD) characteristics
Smoke cigarettes now
|
20 participants
n=93 Participants
|
16 participants
n=4 Participants
|
18 participants
n=27 Participants
|
54 participants
n=483 Participants
|
|
Chronic obstructive pulmonary disease (COPD) characteristics
Smoke 10 or more cigarettes a day now
|
10 participants
n=93 Participants
|
9 participants
n=4 Participants
|
10 participants
n=27 Participants
|
29 participants
n=483 Participants
|
|
Chronic obstructive pulmonary disease (COPD) characteristics
COPD exacerbation in last 12 months
|
5 participants
n=93 Participants
|
7 participants
n=4 Participants
|
7 participants
n=27 Participants
|
19 participants
n=483 Participants
|
|
Post bronchodilator FEV1
|
61 percent predicted
n=93 Participants
|
54 percent predicted
n=4 Participants
|
65 percent predicted
n=27 Participants
|
61 percent predicted
n=483 Participants
|
|
Post bronchodilator FEV1/FVC ratio
|
0.56 ratio
n=93 Participants
|
0.52 ratio
n=4 Participants
|
0.57 ratio
n=27 Participants
|
0.56 ratio
n=483 Participants
|
|
Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)
|
14.8 mL/mmHg/min
n=93 Participants
|
15.7 mL/mmHg/min
n=4 Participants
|
16.3 mL/mmHg/min
n=27 Participants
|
15.7 mL/mmHg/min
n=483 Participants
|
|
Pulse oximetry (SpO2)
|
95 Percentage of oxyhemoglobin
n=93 Participants
|
96 Percentage of oxyhemoglobin
n=4 Participants
|
96 Percentage of oxyhemoglobin
n=27 Participants
|
96 Percentage of oxyhemoglobin
n=483 Participants
|
|
Pulmonary function measures
Total lung capacity
|
6.0 Liters
n=93 Participants
|
5.5 Liters
n=4 Participants
|
6.3 Liters
n=27 Participants
|
6.0 Liters
n=483 Participants
|
|
Pulmonary function measures
Slow vital capacity
|
3.1 Liters
n=93 Participants
|
3.0 Liters
n=4 Participants
|
3.7 Liters
n=27 Participants
|
3.3 Liters
n=483 Participants
|
|
Pulmonary function measures
Forced residual capacity
|
3.6 Liters
n=93 Participants
|
3.6 Liters
n=4 Participants
|
3.4 Liters
n=27 Participants
|
3.5 Liters
n=483 Participants
|
|
Pulmonary function measures
Residual volume
|
2.6 Liters
n=93 Participants
|
2.6 Liters
n=4 Participants
|
2.7 Liters
n=27 Participants
|
2.6 Liters
n=483 Participants
|
|
Use of respiratory medications in prior 2 weeks
Short-acting beta-agonist
|
22 participants
n=93 Participants
|
21 participants
n=4 Participants
|
18 participants
n=27 Participants
|
61 participants
n=483 Participants
|
|
Use of respiratory medications in prior 2 weeks
Long-acting beta-agonist
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
5 participants
n=483 Participants
|
|
Use of respiratory medications in prior 2 weeks
Long-acting beta-agonist & inhaled corticosteroid
|
14 participants
n=93 Participants
|
13 participants
n=4 Participants
|
13 participants
n=27 Participants
|
40 participants
n=483 Participants
|
|
Use of respiratory medications in prior 2 weeks
Long-acting anticholinergic bronchodilator
|
7 participants
n=93 Participants
|
9 participants
n=4 Participants
|
10 participants
n=27 Participants
|
26 participants
n=483 Participants
|
|
Medical Research Council Dyspnea Score
|
2 units on a scale
n=93 Participants
|
2 units on a scale
n=4 Participants
|
2 units on a scale
n=27 Participants
|
2 units on a scale
n=483 Participants
|
|
St Georges Respiratory Questionnaire
Total score
|
43 units on a scale
n=93 Participants
|
47 units on a scale
n=4 Participants
|
39 units on a scale
n=27 Participants
|
40 units on a scale
n=483 Participants
|
|
St Georges Respiratory Questionnaire
Symptoms score
|
58 units on a scale
n=93 Participants
|
55 units on a scale
n=4 Participants
|
50 units on a scale
n=27 Participants
|
52 units on a scale
n=483 Participants
|
|
St Georges Respiratory Questionnaire
Activity score
|
54 units on a scale
n=93 Participants
|
60 units on a scale
n=4 Participants
|
50 units on a scale
n=27 Participants
|
55 units on a scale
n=483 Participants
|
|
St Georges Respiratory Questionnaire
Impacts score
|
27 units on a scale
n=93 Participants
|
34 units on a scale
n=4 Participants
|
26 units on a scale
n=27 Participants
|
28 units on a scale
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=27 Participants
Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth
|
Sulforaphane 25
n=27 Participants
25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth
|
Sulforaphane 150
n=27 Participants
150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth
|
|---|---|---|---|
|
Change From Baseline in Alveolar Macrophage Expression of Nrf2 and Associated Genes at 4 Weeks
NQ01
|
0.80 fold change
Interval 0.53 to 1.09
|
1.03 fold change
Interval 0.56 to 1.6
|
0.94 fold change
Interval 0.59 to 1.72
|
|
Change From Baseline in Alveolar Macrophage Expression of Nrf2 and Associated Genes at 4 Weeks
HO1
|
0.90 fold change
Interval 0.69 to 1.34
|
0.98 fold change
Interval 0.83 to 1.31
|
1.06 fold change
Interval 0.68 to 1.74
|
|
Change From Baseline in Alveolar Macrophage Expression of Nrf2 and Associated Genes at 4 Weeks
AKR1C1
|
0.81 fold change
Interval 0.46 to 1.27
|
1.13 fold change
Interval 0.38 to 1.99
|
0.71 fold change
Interval 0.56 to 1.57
|
|
Change From Baseline in Alveolar Macrophage Expression of Nrf2 and Associated Genes at 4 Weeks
AKR1C3
|
1.03 fold change
Interval 0.76 to 1.37
|
1.02 fold change
Interval 0.67 to 1.31
|
0.87 fold change
Interval 0.4 to 1.32
|
|
Change From Baseline in Alveolar Macrophage Expression of Nrf2 and Associated Genes at 4 Weeks
Nrf2
|
1.14 fold change
Interval 0.79 to 1.52
|
1.05 fold change
Interval 0.87 to 1.47
|
1.13 fold change
Interval 0.74 to 1.28
|
|
Change From Baseline in Alveolar Macrophage Expression of Nrf2 and Associated Genes at 4 Weeks
Keap1
|
0.94 fold change
Interval 0.66 to 1.17
|
0.99 fold change
Interval 0.82 to 1.11
|
1.06 fold change
Interval 0.59 to 1.32
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksPopulation: 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..
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.
Outcome measures
| Measure |
Placebo
n=28 Participants
Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth
|
Sulforaphane 25
n=27 Participants
25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth
|
Sulforaphane 150
n=28 Participants
150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth
|
|---|---|---|---|
|
Change From Baseline in Bronchial Epithelial Cell Expression of Nrf2 at 4 Weeks
|
1.09 fold change
Interval 0.88 to 1.3
|
1.06 fold change
Interval 0.92 to 1.28
|
1.06 fold change
Interval 0.76 to 1.31
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=27 Participants
Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth
|
Sulforaphane 25
n=28 Participants
25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth
|
Sulforaphane 150
n=27 Participants
150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth
|
|---|---|---|---|
|
Change From Baseline in Bronchial Epithelial Cell Expression of NQ01 and Keap1 at 4 Weeks
NQ01
|
1.09 fold change
Interval 0.83 to 1.5
|
1.12 fold change
Interval 0.89 to 1.53
|
0.96 fold change
Interval 0.65 to 1.41
|
|
Change From Baseline in Bronchial Epithelial Cell Expression of NQ01 and Keap1 at 4 Weeks
KEAP1
|
1.12 fold change
Interval 0.71 to 1.54
|
1.39 fold change
Interval 0.99 to 2.24
|
0.87 fold change
Interval 0.58 to 1.1
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=28 Participants
Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth
|
Sulforaphane 25
n=28 Participants
25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth
|
Sulforaphane 150
n=28 Participants
150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth
|
|---|---|---|---|
|
Change From Baseline in Bronchial Epithelial Cell Expression of HO1 at 4 Weeks
|
1.05 fold change
Interval 0.6 to 1.23
|
1.12 fold change
Interval 0.82 to 1.67
|
0.93 fold change
Interval 0.62 to 1.45
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=27 Participants
Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth
|
Sulforaphane 25
n=28 Participants
25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth
|
Sulforaphane 150
n=27 Participants
150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth
|
|---|---|---|---|
|
Change From Baseline in Bronchial Epithelial Cell Expression of AKR1C1 at 4 Weeks
|
1.45 fold change
Interval 0.84 to 1.98
|
1.08 fold change
Interval 0.85 to 2.14
|
0.79 fold change
Interval 0.53 to 1.08
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=27 Participants
Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth
|
Sulforaphane 25
n=27 Participants
25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth
|
Sulforaphane 150
n=27 Participants
150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth
|
|---|---|---|---|
|
Change From Baseline in Bronchial Epithelial Cell Expression of AKR1C3 at 4 Weeks
|
1.10 fold change
Interval 0.74 to 1.62
|
1.38 fold change
Interval 0.91 to 2.64
|
0.87 fold change
Interval 0.5 to 1.68
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: 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.
Isoprostane, an oxidant stress indicator, was measured in expired breath condensate at baseline and 4 weeks.
Outcome measures
| Measure |
Placebo
n=30 Participants
Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth
|
Sulforaphane 25
n=27 Participants
25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth
|
Sulforaphane 150
n=28 Participants
150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth
|
|---|---|---|---|
|
Fold-change in Isoprostane Concentrations (Follow-up to Baseline)
|
1.18 fold change
Interval 0.42 to 1.79
|
0.83 fold change
Interval 0.24 to 1.41
|
0.64 fold change
Interval 0.29 to 1.33
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: 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.
Inflammatory markers were measured in serum samples derived from venipuncture at baseline and 4 weeks in the serum of the participants of the trial.
Outcome measures
| Measure |
Placebo
n=30 Participants
Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth
|
Sulforaphane 25
n=28 Participants
25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth
|
Sulforaphane 150
n=29 Participants
150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth
|
|---|---|---|---|
|
Fold-change in Serum Inflammatory Marker Concentrations (Follow-up to Baseline)
C-reactive protein (mg/L)
|
0.99 fold change
Interval 0.86 to 1.22
|
0.90 fold change
Interval 0.69 to 1.06
|
1.01 fold change
Interval 0.72 to 1.22
|
|
Fold-change in Serum Inflammatory Marker Concentrations (Follow-up to Baseline)
Interleukin-6 (pg/mL)
|
0.75 fold change
Interval 0.65 to 1.19
|
0.90 fold change
Interval 0.76 to 1.08
|
1.12 fold change
Interval 0.88 to 1.37
|
|
Fold-change in Serum Inflammatory Marker Concentrations (Follow-up to Baseline)
Interleukin-8 (pg/mL)
|
1.06 fold change
Interval 0.86 to 1.32
|
1.04 fold change
Interval 0.87 to 1.17
|
1.03 fold change
Interval 0.83 to 1.21
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=27 Participants
Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth
|
Sulforaphane 25
n=28 Participants
25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth
|
Sulforaphane 150
n=28 Participants
150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth
|
|---|---|---|---|
|
Fold-change in Inflammatory Marker Concentrations in Bronchial Alveolar Lavage (Follow-up to Baseline) by Treatment Group
Interleukin-8 (pg/mg)
|
1.22 fold change
Interval 0.68 to 2.75
|
0.94 fold change
Interval 0.52 to 2.22
|
1.11 fold change
Interval 0.42 to 2.54
|
|
Fold-change in Inflammatory Marker Concentrations in Bronchial Alveolar Lavage (Follow-up to Baseline) by Treatment Group
Secretory leukoprotease inhibitor (pg/mg)
|
1.51 fold change
Interval 0.83 to 1.9
|
1.09 fold change
Interval 0.85 to 1.49
|
1.12 fold change
Interval 0.65 to 1.51
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: 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.
Inflammatory markers were measured in plasma at baseline and 4 weeks. Thiobarbituric acid reactive substances were measured in nmol malondialdehyde (MDA)/mL.
Outcome measures
| Measure |
Placebo
n=30 Participants
Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth
|
Sulforaphane 25
n=28 Participants
25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth
|
Sulforaphane 150
n=29 Participants
150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth
|
|---|---|---|---|
|
Fold-change in Plasma Inflammatory Marker Concentrations (Follow-up to Baseline)
Isoprostane (ng/mg)
|
0.89 fold change
Interval 0.55 to 1.22
|
0.90 fold change
Interval 0.63 to 1.74
|
0.88 fold change
Interval 0.55 to 1.37
|
|
Fold-change in Plasma Inflammatory Marker Concentrations (Follow-up to Baseline)
Thiobarbituric acid reactive substances
|
0.96 fold change
Interval 0.77 to 1.19
|
1.05 fold change
Interval 0.88 to 1.17
|
1.06 fold change
Interval 0.84 to 1.27
|
|
Fold-change in Plasma Inflammatory Marker Concentrations (Follow-up to Baseline)
Total antioxidants (mM Trolox equivalents/L)
|
0.97 fold change
Interval 0.92 to 1.03
|
0.92 fold change
Interval 0.85 to 1.03
|
0.97 fold change
Interval 0.9 to 1.04
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Sulforaphane 25
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Sulforaphane 150
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=31 participants at risk
Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth
|
Sulforaphane 25
n=29 participants at risk
25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth
|
Sulforaphane 150
n=29 participants at risk
150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth
|
|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/31
Assessed via study questionnaires.
|
3.4%
1/29 • Number of events 1
Assessed via study questionnaires.
|
0.00%
0/29
Assessed via study questionnaires.
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
0.00%
0/31
Assessed via study questionnaires.
|
3.4%
1/29 • Number of events 1
Assessed via study questionnaires.
|
0.00%
0/29
Assessed via study questionnaires.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/31
Assessed via study questionnaires.
|
0.00%
0/29
Assessed via study questionnaires.
|
3.4%
1/29 • Number of events 1
Assessed via study questionnaires.
|
Other adverse events
| Measure |
Placebo
n=31 participants at risk
Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth
|
Sulforaphane 25
n=29 participants at risk
25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth
|
Sulforaphane 150
n=29 participants at risk
150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.2%
1/31 • Number of events 1
Assessed via study questionnaires.
|
6.9%
2/29 • Number of events 2
Assessed via study questionnaires.
|
20.7%
6/29 • Number of events 6
Assessed via study questionnaires.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/31
Assessed via study questionnaires.
|
3.4%
1/29 • Number of events 1
Assessed via study questionnaires.
|
0.00%
0/29
Assessed via study questionnaires.
|
|
Gastrointestinal disorders
Poor appetite
|
3.2%
1/31 • Number of events 1
Assessed via study questionnaires.
|
6.9%
2/29 • Number of events 2
Assessed via study questionnaires.
|
6.9%
2/29 • Number of events 2
Assessed via study questionnaires.
|
|
Gastrointestinal disorders
Bad taste in mouth
|
6.5%
2/31 • Number of events 2
Assessed via study questionnaires.
|
24.1%
7/29 • Number of events 7
Assessed via study questionnaires.
|
31.0%
9/29 • Number of events 9
Assessed via study questionnaires.
|
|
Gastrointestinal disorders
Heartburn
|
3.2%
1/31 • Number of events 1
Assessed via study questionnaires.
|
20.7%
6/29 • Number of events 6
Assessed via study questionnaires.
|
24.1%
7/29 • Number of events 7
Assessed via study questionnaires.
|
|
General disorders
Headache
|
6.5%
2/31 • Number of events 2
Assessed via study questionnaires.
|
6.9%
2/29 • Number of events 2
Assessed via study questionnaires.
|
3.4%
1/29 • Number of events 1
Assessed via study questionnaires.
|
|
General disorders
Fatigue
|
9.7%
3/31 • Number of events 3
Assessed via study questionnaires.
|
17.2%
5/29 • Number of events 5
Assessed via study questionnaires.
|
6.9%
2/29 • Number of events 2
Assessed via study questionnaires.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
3.2%
1/31 • Number of events 1
Assessed via study questionnaires.
|
6.9%
2/29 • Number of events 2
Assessed via study questionnaires.
|
3.4%
1/29 • Number of events 1
Assessed via study questionnaires.
|
|
Gastrointestinal disorders
Bloating/gas
|
16.1%
5/31 • Number of events 5
Assessed via study questionnaires.
|
24.1%
7/29 • Number of events 7
Assessed via study questionnaires.
|
20.7%
6/29 • Number of events 6
Assessed via study questionnaires.
|
|
Gastrointestinal disorders
Diarrhea
|
6.5%
2/31 • Number of events 2
Assessed via study questionnaires.
|
10.3%
3/29 • Number of events 3
Assessed via study questionnaires.
|
6.9%
2/29 • Number of events 2
Assessed via study questionnaires.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.2%
1/31 • Number of events 1
Assessed via study questionnaires.
|
10.3%
3/29 • Number of events 3
Assessed via study questionnaires.
|
20.7%
6/29 • Number of events 6
Assessed via study questionnaires.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infection
|
3.2%
1/31 • Number of events 1
Assessed via study questionnaires.
|
3.4%
1/29 • Number of events 1
Assessed via study questionnaires.
|
3.4%
1/29 • Number of events 1
Assessed via study questionnaires.
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
0.00%
0/31
Assessed via study questionnaires.
|
6.9%
2/29 • Number of events 2
Assessed via study questionnaires.
|
0.00%
0/29
Assessed via study questionnaires.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/31
Assessed via study questionnaires.
|
3.4%
1/29 • Number of events 1
Assessed via study questionnaires.
|
3.4%
1/29 • Number of events 1
Assessed via study questionnaires.
|
|
Respiratory, thoracic and mediastinal disorders
Increased phlegm
|
3.2%
1/31 • Number of events 1
Assessed via study questionnaires.
|
0.00%
0/29
Assessed via study questionnaires.
|
3.4%
1/29 • Number of events 1
Assessed via study questionnaires.
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.00%
0/31
Assessed via study questionnaires.
|
3.4%
1/29 • Number of events 1
Assessed via study questionnaires.
|
3.4%
1/29 • Number of events 1
Assessed via study questionnaires.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/31
Assessed via study questionnaires.
|
3.4%
1/29 • Number of events 1
Assessed via study questionnaires.
|
3.4%
1/29 • Number of events 1
Assessed via study questionnaires.
|
Additional Information
Alexis Rea
Johns Hopkins University School of Medicine
Phone: (443) 287-8496
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place