Clinical trial NCT01315665: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: broccoli sprouts
sulforaphane
triterpenoid
Nrf2 activation
cystic fibrosis
healthy volunteers
anti-inflammatory
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2011-03-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).

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

Primary outcomes:
measure: Nrf2 Activation in Nasal Epithelial Cells
timeFrame: Baseline and of end of 5 day treatment period
Secondary outcomes:
measure: Measures of Lipid Peroxidation in Nasal Epithelial Cells
timeFrame: End of 5 day treatment period
measure: Measures of Glutathione From Blood Lymphocytes
timeFrame: Baseline and end of 5 day treatment period
measure: Measures of Oxidative Stress in Urine
timeFrame: Baseline and end of 5 day treatment period
measure: Measure of Neutrophil Migration Into the Gingival Crevices
timeFrame: Baseline and end of 5 day treatment period
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Rainbow Babies and Children's Hospital
state: Ohio
Study officials:
affiliation: Rainbow Babies and Children's Hospital
name: James F. Chmiel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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