Trial Outcomes & Findings for Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation (NCT NCT01315665)
NCT ID: NCT01315665
Last Updated: 2019-02-15
Results Overview
Number of subjects with activated Nrf-2 in the cytoplasm of nasal epithelial cells after 5 days of study treatment (consuming broccoli sprouts)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Baseline and of end of 5 day treatment period
Results posted on
2019-02-15
Participant Flow
Participant milestones
| Measure |
Healthy Volunteers
Healthy volunteers
Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.
|
Subjects With Cystic Fibrosis
Subjects with cystic fibrosis
Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
5
|
|
Overall Study
COMPLETED
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation
Baseline characteristics by cohort
| Measure |
Healthy Volunteers
n=10 Participants
Healthy volunteers
Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.
|
Subjects With Cystic Fibrosis
n=5 Participants
Subjects with cystic fibrosis
Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
5 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and of end of 5 day treatment periodNumber of subjects with activated Nrf-2 in the cytoplasm of nasal epithelial cells after 5 days of study treatment (consuming broccoli sprouts)
Outcome measures
| Measure |
Healthy Volunteers
n=10 Participants
Healthy volunteers
Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.
|
Subjects With Cystic Fibrosis
n=5 Participants
Subjects with cystic fibrosis
Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.
|
|---|---|---|
|
Nrf2 Activation in Nasal Epithelial Cells
Baseline
|
0 participants
|
0 participants
|
|
Nrf2 Activation in Nasal Epithelial Cells
Day 5, End of treatment
|
4 participants
|
4 participants
|
SECONDARY outcome
Timeframe: End of 5 day treatment periodPopulation: Data not collected and will not be analyzed.
Products of lipid peroxidation will be determined by western blot analysis on nasal epithelial cells obtained by curettage after 5 days of study treatment (consuming broccoli sprouts)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and end of 5 day treatment periodPopulation: Not enough blood could be obtained from one of the healthy volunteers. Therefore, glutathione from blood lymphocytes could not be evaluated from that healthy volunteer. With respect to this outcome measure, only results from 9 healthy volunteers are reported.
Change in lymphocyte glutathione measurements after 5 days of study treatment (consuming broccoli sprouts).
Outcome measures
| Measure |
Healthy Volunteers
n=9 Participants
Healthy volunteers
Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.
|
Subjects With Cystic Fibrosis
n=5 Participants
Subjects with cystic fibrosis
Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.
|
|---|---|---|
|
Measures of Glutathione From Blood Lymphocytes
|
14.3 Micro Molar
Standard Deviation 25.9
|
4.7 Micro Molar
Standard Deviation 48.1
|
SECONDARY outcome
Timeframe: Baseline and end of 5 day treatment periodChange in urine bromotyrosine (measured by mass spectrometry) will be measured after 5 days of study treatment (consuming broccoli sprouts).
Outcome measures
| Measure |
Healthy Volunteers
n=10 Participants
Healthy volunteers
Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.
|
Subjects With Cystic Fibrosis
n=5 Participants
Subjects with cystic fibrosis
Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.
|
|---|---|---|
|
Measures of Oxidative Stress in Urine
|
0.09 ng/mg creatinine (Log10)
Standard Deviation 0.23
|
0.01 ng/mg creatinine (Log10)
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: Baseline and end of 5 day treatment periodChange in gingival neutrophils measured after 5 days of study treatment (consuming broccoli sprouts). Patients will perform mouthwashes with normal saline. Neutrophil counts will be performed on fresh samples. Acridine orange will be added to the saline rinses and neutrophils will be counted under the microscope.
Outcome measures
| Measure |
Healthy Volunteers
n=10 Participants
Healthy volunteers
Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.
|
Subjects With Cystic Fibrosis
n=5 Participants
Subjects with cystic fibrosis
Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.
|
|---|---|---|
|
Measure of Neutrophil Migration Into the Gingival Crevices
|
-0.06 Neutrophils/mL (Log10)
Standard Deviation 0.14
|
-0.02 Neutrophils/mL (Log10)
Standard Deviation 0.04
|
Adverse Events
Healthy Volunteers
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Subjects With Cystic Fibrosis
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Volunteers
n=10 participants at risk
Healthy volunteers
Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.
|
Subjects With Cystic Fibrosis
n=5 participants at risk
Subjects with cystic fibrosis
Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
40.0%
4/10 • Number of events 7
|
0.00%
0/5
|
|
Gastrointestinal disorders
Stomach pain
|
30.0%
3/10 • Number of events 6
|
0.00%
0/5
|
|
Renal and urinary disorders
Blood in urine
|
0.00%
0/10
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Emesis
|
20.0%
2/10 • Number of events 2
|
0.00%
0/5
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Number of events 1
|
0.00%
0/5
|
|
Gastrointestinal disorders
Gas
|
30.0%
3/10 • Number of events 3
|
0.00%
0/5
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Heartburn
|
20.0%
2/10 • Number of events 3
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Number of events 1
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
10.0%
1/10 • Number of events 1
|
0.00%
0/5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10
|
20.0%
1/5 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place