Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01315665
• Date of registration: 14/03/2011
• Prospective Registration: Yes
• Primary sponsor: University Hospitals Cleveland Medical Center
• Public title: Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation
• Scientific 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
• Date of first enrolment: April 2011
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01315665
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: James F. Chmiel, MD, MPH
• Affiliation: Rainbow Babies and Children's Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 49 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Dietary Supplement: Broccoli sprouts

Primary Outcome(s)

Nrf2 Activation in Nasal Epithelial Cells [Time Frame: Baseline and of end of 5 day treatment period]

Secondary Outcome(s)

Measures of Lipid Peroxidation in Nasal Epithelial Cells [Time Frame: End of 5 day treatment period]

Measures of Oxidative Stress in Urine [Time Frame: Baseline and end of 5 day treatment period]

Measure of Neutrophil Migration Into the Gingival Crevices [Time Frame: Baseline and end of 5 day treatment period]

Measures of Glutathione From Blood Lymphocytes [Time Frame: Baseline and end of 5 day treatment period]

Secondary ID(s)

UHCMC-CFRC-2011-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cystic Fibrosis Foundation

Results

• Results available: Yes
• Date Posted: 15/02/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01315665