The Effects of Broccoli Sprout Extract on Obstructive Lung Disease

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

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older 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

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
• Other Study ID Numbers: RB-001
• First Posted: October 14, 2009
• 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