The Effects of Broccoli Sprout Extract on Obstructive Lung Disease
Primary Purpose
Asthma, COPD
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
broccoli sprout extract
Sponsored by
About this trial
This is an interventional basic science trial for Asthma
Eligibility 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.
Sites / Locations
- Johns Hopkins Medical Institutions
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
broccoli sprout extract
Arm Description
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.
Outcomes
Primary Outcome Measures
The Primary Outcome is the Change in Bronchodilation and Bronchoprotection After Broccoli Sprout Extract
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
Changes in size airways as measured by computed tomography
Full Information
NCT ID
NCT00994604
First Posted
October 13, 2009
Last Updated
December 5, 2016
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT00994604
Brief Title
The Effects of Broccoli Sprout Extract on Obstructive Lung Disease
Official Title
The Effects of Broccoli Sprout Extract on Obstructive Lung Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, COPD
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
broccoli sprout extract
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
broccoli sprout extract
Intervention Description
consumption of broccoli sprout extract for 2 weeks
Primary Outcome Measure Information:
Title
The Primary Outcome is the Change in Bronchodilation and Bronchoprotection After Broccoli Sprout Extract
Description
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
Time Frame
baseline and two weeks
Secondary Outcome Measure Information:
Title
Changes in Airway Size by Computed Tomography
Description
Changes in size airways as measured by computed tomography
Time Frame
baseline and after two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Brown, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Medical Institutions
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This was a pilot study.
Learn more about this trial
The Effects of Broccoli Sprout Extract on Obstructive Lung Disease
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