Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation
Recruitment status was Active, not recruiting
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|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|
- 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.
- 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of glutathione from blood lymphocytes [ Time Frame: Days 3 and 8 ] [ Designated as safety issue: No ]Blood will be withdrawn from the subjects and monocytic cells will be obtained for analysis of intracellular glutathione.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
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||September 2011|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: Broccoli Sprouts
Healthy volunteers and subjects with 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
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315665
|United States, Ohio|
|Rainbow Babies and Children's Hospital|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||James F. Chmiel, MD, MPH||Rainbow Babies and Children's Hospital|