The Effects of Broccoli Sprout Extract on Obstructive Lung Disease
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|ClinicalTrials.gov Identifier: NCT00994604|
Recruitment Status : Completed
First Posted : October 14, 2009
Results First Posted : January 27, 2017
Last Update Posted : January 27, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Asthma COPD||Drug: broccoli sprout extract||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|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|
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
- 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
- Changes in Airway Size by Computed Tomography [ Time Frame: baseline and after two weeks ]Changes in size airways as measured by computed tomography
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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|
- currently on chronic oral steroid medications
- current respiratory symptoms
- 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.
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
|United States, Maryland|
|Johns Hopkins Medical Institutions|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Robert Brown, MD||Johns Hopkins University|
|Responsible Party:||Robert Brown, Professor, Johns Hopkins University|
|Other Study ID Numbers:||
|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.|
Lung Diseases, Obstructive
Respiratory Tract Diseases