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The Effects of Broccoli Sprout Extract on Obstructive Lung Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00994604
First Posted: October 14, 2009
Last Update Posted: January 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Robert Brown, Johns Hopkins University
  Purpose
The purpose of this study is to examine whether broccoli sprout extract can effect lung function measurements in individuals with asthma and COPD.

Condition Intervention
Asthma COPD Drug: broccoli sprout extract

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of Broccoli Sprout Extract on Obstructive Lung Disease

Resource links provided by NLM:


Further study details as provided by Robert Brown, Johns Hopkins University:

Primary Outcome Measures:
  • The Primary Outcome is the Change in Bronchodilation and Bronchoprotection After Broccoli Sprout Extract [ Time Frame: baseline and two weeks ]

    Bronchodilator index = (1- ((1 - ((forced expiratory volume in 1 second after Methacholine A and after Deep Inspiration )÷( forced expiratory volume in 1 second baseline)))÷ (1 - ((forced expiratory volume in 1 second after Methacholine)÷( forced expiratory volume in 1 second baseline)))))x100

    Bronchoprotection index = (1- ((1 - ((forced expiratory volume in 1 second after Deep Inspirations and after Methacholine B )÷( forced expiratory volume in 1 second baseline B)))÷(1 - ((forced expiratory volume in 1 second after Methacholine A)÷( forced expiratory volume in 1 second baseline A))))) x 100



Secondary Outcome Measures:
  • Changes in Airway Size by Computed Tomography [ Time Frame: baseline and after two weeks ]
    Changes in size airways as measured by computed tomography


Enrollment: 51
Study Start Date: October 2009
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: broccoli sprout extract
This a before and after treatment study. The subjects will consumer broccoli sprout extract (BSE) for two weeks (14d). Lung function and Chest CT will be performed before and after BSE consumption.
Drug: broccoli sprout extract
consumption of broccoli sprout extract for 2 weeks

Detailed Description:

Asthma afflicts 23 million people, results in nearly 13 million ambulatory physician encounters, and 440,000 hospitalizations annually. The economic burden for 2010 is estimated to run $20.7 billion.

Although steroids are the mainstay of treatment, they do not "cure" the disease. While inflammation may be the inciting factor, other mechanisms must play a crucial role in this process. Elevated oxidative stress could cause the kind of chronic inflammation associated with asthma, and could provide an explanation for recurrent asthma attacks. Cigarette smoke, both primary and secondary exposure, worsens the oxidative stress balance in the airways. Thus, the continuing focus on simply treating the inflammation is a barrier to progress. It is critical to examine other factors, such as abnormal oxidative stress through specific pathways that may affect airway inflammation and asthma attacks.

One compound, that repairs oxidative stress pathways, is sulforaphane, a food compound found in vegetables, including broccoli sprouts. Preliminary data demonstrate that broccoli sprout extract (BSE), rich in sulforaphane, improves airflow measures in asthmatics.

We plan to examine whether the airflow abnormalities in asthma, and the exacerbation from cigarette smoke, can be prevented by the administration of BSE, and determine the primary inflammatory and oxidative stress signaling pathways involved in the protection provided by BSE.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • asthma
  • COPD

Exclusion Criteria:

  • currently on chronic oral steroid medications
  • current respiratory symptoms
  • pregnant
  • FEV1 less than 40% predicted at baseline
  • extreme degrees of bronchial hyperreactivity
  • recent respiratory infection (<3 weeks)
  • unstable symptoms in the prior month
  • a history of intubation for respiratory symptoms within the past year
  • any history of cardiac disease.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00994604


Locations
United States, Maryland
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Robert Brown, MD Johns Hopkins University
  More Information

Responsible Party: Robert Brown, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00994604     History of Changes
Other Study ID Numbers: RB-001
First Submitted: October 13, 2009
First Posted: October 14, 2009
Results First Submitted: August 9, 2016
Results First Posted: January 27, 2017
Last Update Posted: January 27, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This was a pilot study.

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases