Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation

January 29, 2019 updated by: James F. Chmiel, University Hospitals Cleveland Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Rainbow Babies and Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy volunteers
100 grams of raw broccoli sprouts once daily for 5 consecutive days
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 Names:
  • sulforaphane
Experimental: Subjects with cystic fibrosis
100 grams of raw broccoli sprouts once daily for 5 consecutive days
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 Names:
  • sulforaphane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nrf2 Activation in Nasal Epithelial Cells
Time Frame: Baseline and of end of 5 day treatment period
Number of subjects with activated Nrf-2 in the cytoplasm of nasal epithelial cells after 5 days of study treatment (consuming broccoli sprouts)
Baseline and of end of 5 day treatment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measures of Lipid Peroxidation in Nasal Epithelial Cells
Time Frame: End of 5 day treatment period
Products of lipid peroxidation will be determined by western blot analysis on nasal epithelial cells obtained by curettage after 5 days of study treatment (consuming broccoli sprouts)
End of 5 day treatment period
Measures of Glutathione From Blood Lymphocytes
Time Frame: Baseline and end of 5 day treatment period
Change in lymphocyte glutathione measurements after 5 days of study treatment (consuming broccoli sprouts).
Baseline and end of 5 day treatment period
Measures of Oxidative Stress in Urine
Time Frame: Baseline and end of 5 day treatment period
Change in urine bromotyrosine (measured by mass spectrometry) will be measured after 5 days of study treatment (consuming broccoli sprouts).
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
Change in gingival neutrophils measured after 5 days of study treatment (consuming broccoli sprouts). Patients will perform mouthwashes with normal saline. Neutrophil counts will be performed on fresh samples. Acridine orange will be added to the saline rinses and neutrophils will be counted under the microscope.
Baseline and end of 5 day treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Collaborators

Cystic Fibrosis Foundation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

March 14, 2011

First Submitted That Met QC Criteria

March 14, 2011

First Posted (Estimate)

March 15, 2011

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHCMC-CFRC-2011-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cystic Fibrosis

Clinical Trials on Broccoli sprouts

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe