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The Effects of Broccoli Sprout Extract on Obstructive Lung Disease

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. Identifier: NCT00994604
Recruitment Status : Completed
First Posted : October 14, 2009
Results First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Information provided by (Responsible Party):
Robert Brown, Johns Hopkins University

Brief Summary:
The purpose of this study is to examine whether broccoli sprout extract can effect lung function measurements in individuals with asthma and COPD.

Condition or disease Intervention/treatment Phase
Asthma COPD Drug: broccoli sprout extract Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
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
Study Start Date : October 2009
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Changes in Airway Size by Computed Tomography [ Time Frame: baseline and after two weeks ]
    Changes in size airways as measured by computed tomography

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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.

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 identifier (NCT number): NCT00994604

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United States, Maryland
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
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Principal Investigator: Robert Brown, MD Johns Hopkins University
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Responsible Party: Robert Brown, Professor, Johns Hopkins University Identifier: NCT00994604    
Other Study ID Numbers: RB-001
First Posted: October 14, 2009    Key Record Dates
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:
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Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases