Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University Hospitals of Cleveland.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by:
University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01315665
First received: March 14, 2011
Last updated: August 3, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Cystic Fibrosis
Dietary Supplement: Broccoli sprouts

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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    Blood will be withdrawn from the subjects and monocytic cells will be obtained for analysis of intracellular glutathione.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


Estimated Enrollment: 15
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)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315665

Locations
United States, Ohio
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals of Cleveland
Cystic Fibrosis Foundation
Investigators
Principal Investigator: James F. Chmiel, MD, MPH Rainbow Babies and Children's Hospital
  More Information

Publications:

Responsible Party: James F. Chmiel, M.D., M.P.H., Associate Professor of Pediatrics, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01315665     History of Changes
Other Study ID Numbers: UHCMC-CFRC-2011-01
Study First Received: March 14, 2011
Last Updated: August 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:
broccoli sprouts
sulforaphane
triterpenoid
Nrf2 activation
cystic fibrosis
healthy volunteers
anti-inflammatory

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Sulforafan
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014