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The Effects of Broccoli Sprout Extract on Obstructive Lung Disease

The Effects of Broccoli Sprout Extract on Obstructive Lung Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00994604
Enrollment
51
Registered
2009-10-14
Start date
2009-10-31
Completion date
2015-08-31
Last updated
2017-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, COPD

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.

Interventions

consumption of broccoli sprout extract for 2 weeks

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
The Primary Outcome is the Change in Bronchodilation and Bronchoprotection After Broccoli Sprout Extractbaseline and two weeksBronchodilator 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

MeasureTime frameDescription
Changes in Airway Size by Computed Tomographybaseline and after two weeksChanges in size airways as measured by computed tomography

Countries

United States

Participant flow

Participants by arm

ArmCount
Broccoli Sprout Extract
broccoli sprout extract: consumption of broccoli sprout extract for 2 weeks
51
Total51

Baseline characteristics

CharacteristicBroccoli Sprout Extract
Age, Continuous38 years
STANDARD_DEVIATION 13
Gender
Female
29 Participants
Gender
Male
22 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 51
serious
Total, serious adverse events
0 / 51

Outcome results

Primary

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

Time frame: baseline and two weeks

ArmMeasureValue (MEAN)Dispersion
Broccoli Sprout Extract - BPThe Primary Outcome is the Change in Bronchodilation and Bronchoprotection After Broccoli Sprout Extract10.3 indexStandard Deviation 57.1
Broccoli Sprout Extract - BDThe Primary Outcome is the Change in Bronchodilation and Bronchoprotection After Broccoli Sprout Extract26.7 indexStandard Deviation 30.6
Secondary

Changes in Airway Size by Computed Tomography

Changes in size airways as measured by computed tomography

Time frame: baseline and after two weeks

ArmMeasureValue (MEAN)Dispersion
Broccoli Sprout Extract - BPChanges in Airway Size by Computed Tomography30.9 size in mm^2Standard Deviation 1.8
Broccoli Sprout Extract - BDChanges in Airway Size by Computed Tomography32 size in mm^2Standard Deviation 4.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026