N/A
N=15
Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT01315665 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Nrf2 Activation in Nasal Epithelial Cells — 0; 0; 4; 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Broccoli sprouts (Dietary_supplement)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nrf2 Activation in Nasal Epithelial Cells |
0; 0; 4; 4 | — |
| SECONDARY Measures of Lipid Peroxidation in Nasal Epithelial Cells |
— | — |
| SECONDARY Measures of Glutathione From Blood Lymphocytes |
14.3; 4.7 | — |
| SECONDARY Measures of Oxidative Stress in Urine |
0.09; 0.01 | — |
| SECONDARY Measure of Neutrophil Migration Into the Gingival Crevices |
-0.06; -0.02 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy volunteers and patients with cystic fibrosis ≥ 18 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
Data sourced from ClinicalTrials.gov (NCT01315665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.