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Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation

This study has been completed.
Sponsor:
Collaborator:
Cystic Fibrosis Foundation Therapeutics
Information provided by (Responsible Party):
James F. Chmiel, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01315665
First received: March 14, 2011
Last updated: May 28, 2015
Last verified: May 2015

March 14, 2011
May 28, 2015
April 2011
February 2013   (final data collection date for primary outcome measure)
Nrf2 activation in nasal epithelial cells [ Time Frame: Days 3 and 8 ] [ Designated as safety issue: No ]
Nrf-2 will be determined by western blot analysis from nasal epithelial cells obtained by curretage.
Same as current
Complete list of historical versions of study NCT01315665 on ClinicalTrials.gov Archive Site
  • Measures of lipid peroxidation in nasal epithelial cells [ Time Frame: Days 3 and 8 ] [ Designated as safety issue: No ]
    Products of lipid peroxidation will be determined by western blot analysis on nasal epithelial cells obtained by curretage.
  • Measures of glutathione from blood lymphocytes [ Time Frame: Days 3 and 8 ] [ Designated as safety issue: No ]
    Blood will be withdrawn from the subjects and monocytic cells will be obtained for analysis of intracellular glutathione.
  • Measures of oxidative stress in urine [ Time Frame: Days 3 and 8 ] [ Designated as safety issue: No ]
    Urine will be obtained on days 3 and 8 for quantification of F2-isoprostane and bromotyrisine.
  • Measure of neutrophil migration into the gingival crevices [ Time Frame: Days 1, 2, 3, 6, 7, 8 ] [ Designated as safety issue: No ]
    Patients will perform mouthwashes with normal saline. Neutrophil counts will be performed on fresh samples. Acradine orange will be added to the saline rinses and neutrophils will be counted under the microscope
Same as current
Not Provided
Not Provided
 
Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation
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
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.

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).

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Cystic Fibrosis
Dietary Supplement: Broccoli sprouts
Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.
Other Name: sulforaphane
Experimental: Broccoli Sprouts
Healthy volunteers and subjects with cystic fibrosis
Intervention: Dietary Supplement: Broccoli sprouts

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 49 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01315665
UHCMC-CFRC-2011-01
No
Not Provided
Not Provided
James F. Chmiel, University Hospital Case Medical Center
University Hospitals Cleveland Medical Center
Cystic Fibrosis Foundation Therapeutics
Principal Investigator: James F. Chmiel, MD, MPH Rainbow Babies and Children's Hospital
University Hospitals Cleveland Medical Center
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP