Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Broccoli sprouts
Sponsored by
About this trial
This is an interventional basic science trial for Cystic Fibrosis focused on measuring broccoli sprouts, sulforaphane, triterpenoid, Nrf2 activation, cystic fibrosis, healthy volunteers, anti-inflammatory
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteers and patients with cystic fibrosis ≥ 18 < 50 years of age
- Healthy volunteers must be in general good health as determined by a medical history
- CF subjects must have a documented diagnosis of CF (positive sweat chloride ≥ 60 mEq/liter, by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with CF accompanied by one or more clinical features with the CF) phenotype
- CF subjects must have a baseline FEV1 percent predicted > 50% (in the last year, obtained from medical record)
- CF subjects must be clinically stable: free of any acute illness for > 14 days CF subjects must not have been prescribed any new systemic antibiotics for the 14 days prior to enrollment
- Ability to provide written informed consent
- Ability to adhere to the protocol
Exclusion Criteria:
- Use of NSAIDS (e.g., ibuprofen) or corticosteroids including inhaled steroids for the 4 weeks prior to enrollment
- Active gingival disease (active tooth or gum disease)
- History of nephrolithiasis or cholelithiasis
- Allergy to broccoli
- Any chronic condition that compromises the participant as determined by medical history
- Pregnancy
- Inability to tolerate the study procedures
- CF subjects: Infected with B. cepacia
Sites / Locations
- Rainbow Babies and Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy volunteers
Subjects with cystic fibrosis
Arm Description
100 grams of raw broccoli sprouts once daily for 5 consecutive days
100 grams of raw broccoli sprouts once daily for 5 consecutive days
Outcomes
Primary Outcome Measures
Nrf2 Activation in Nasal Epithelial Cells
Number of subjects with activated Nrf-2 in the cytoplasm of nasal epithelial cells after 5 days of study treatment (consuming broccoli sprouts)
Secondary Outcome Measures
Measures of Lipid Peroxidation in Nasal Epithelial Cells
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)
Measures of Glutathione From Blood Lymphocytes
Change in lymphocyte glutathione measurements after 5 days of study treatment (consuming broccoli sprouts).
Measures of Oxidative Stress in Urine
Change in urine bromotyrosine (measured by mass spectrometry) will be measured after 5 days of study treatment (consuming broccoli sprouts).
Measure of Neutrophil Migration Into the Gingival Crevices
Change 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.
Full Information
NCT ID
NCT01315665
First Posted
March 14, 2011
Last Updated
January 29, 2019
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Cystic Fibrosis Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01315665
Brief Title
Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation
Official Title
Evaluation of the Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation, Measures of Oxidative Stress, and Neutrophil Migration to Mucosal Surfaces in Healthy and CF Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Cystic Fibrosis Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study to investigate the effect of sulforaphane from macerated broccoli sprouts in humans and to evaluate less invasive methods of assessing potential anti-inflammatory drugs in CF.
Detailed Description
The hypothesis to be tested is that sulforaphane consumed from macerated broccoli sprouts will activate Nrf2, reduce oxidative metabolites and reduce neutrophils in the oral mucosa after 5 days of therapy in healthy volunteers and CF subjects.
The study requires 6 brief outpatient visits over 8 days. Study procedures include medical history, height, weight, vital signs, blood and urine collection, nasal curettage, saline mouthwash, and ingestion of broccoli sprouts (100 gm of 3 to 5 day old raw broccoli sprouts once daily for 5 consecutive days).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
broccoli sprouts, sulforaphane, triterpenoid, Nrf2 activation, cystic fibrosis, healthy volunteers, anti-inflammatory
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
100 grams of raw broccoli sprouts once daily for 5 consecutive days
Arm Title
Subjects with cystic fibrosis
Arm Type
Experimental
Arm Description
100 grams of raw broccoli sprouts once daily for 5 consecutive days
Intervention Type
Dietary Supplement
Intervention Name(s)
Broccoli sprouts
Other Intervention Name(s)
sulforaphane
Intervention Description
Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.
Primary Outcome Measure Information:
Title
Nrf2 Activation in Nasal Epithelial Cells
Description
Number of subjects with activated Nrf-2 in the cytoplasm of nasal epithelial cells after 5 days of study treatment (consuming broccoli sprouts)
Time Frame
Baseline and of end of 5 day treatment period
Secondary Outcome Measure Information:
Title
Measures of Lipid Peroxidation in Nasal Epithelial Cells
Description
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)
Time Frame
End of 5 day treatment period
Title
Measures of Glutathione From Blood Lymphocytes
Description
Change in lymphocyte glutathione measurements after 5 days of study treatment (consuming broccoli sprouts).
Time Frame
Baseline and end of 5 day treatment period
Title
Measures of Oxidative Stress in Urine
Description
Change in urine bromotyrosine (measured by mass spectrometry) will be measured after 5 days of study treatment (consuming broccoli sprouts).
Time Frame
Baseline and end of 5 day treatment period
Title
Measure of Neutrophil Migration Into the Gingival Crevices
Description
Change 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.
Time Frame
Baseline and end of 5 day treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers and patients with cystic fibrosis ≥ 18 < 50 years of age
Healthy volunteers must be in general good health as determined by a medical history
CF subjects must have a documented diagnosis of CF (positive sweat chloride ≥ 60 mEq/liter, by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with CF accompanied by one or more clinical features with the CF) phenotype
CF subjects must have a baseline FEV1 percent predicted > 50% (in the last year, obtained from medical record)
CF subjects must be clinically stable: free of any acute illness for > 14 days CF subjects must not have been prescribed any new systemic antibiotics for the 14 days prior to enrollment
Ability to provide written informed consent
Ability to adhere to the protocol
Exclusion Criteria:
Use of NSAIDS (e.g., ibuprofen) or corticosteroids including inhaled steroids for the 4 weeks prior to enrollment
Active gingival disease (active tooth or gum disease)
History of nephrolithiasis or cholelithiasis
Allergy to broccoli
Any chronic condition that compromises the participant as determined by medical history
Pregnancy
Inability to tolerate the study procedures
CF subjects: Infected with B. cepacia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James F. Chmiel, MD, MPH
Organizational Affiliation
Rainbow Babies and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
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Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation
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