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
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Nrf2 Activation in Nasal Epithelial Cells
Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Nrf2 Activation in Nasal Epithelial Cells
Time Frame: Baseline and of end of 5 day treatment period
Number of subjects with activated Nrf-2 in the cytoplasm of nasal epithelial cells after 5 days of study treatment (consuming broccoli sprouts)
Secondary Outcomes
- Measures of Oxidative Stress in Urine(Baseline and end of 5 day treatment period)
- Measure of Neutrophil Migration Into the Gingival Crevices(Baseline and end of 5 day treatment period)
- Measures of Lipid Peroxidation in Nasal Epithelial Cells(End of 5 day treatment period)
- Measures of Glutathione From Blood Lymphocytes(Baseline and end of 5 day treatment period)
Investigators
James F. Chmiel
Associate Professor of Pediatrics
University Hospitals Cleveland Medical Center