The Effects of Broccoli Sprout Extract on Obstructive Lung Disease

NCT ID: NCT00994604

Last Updated: 2017-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2015-08-31

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.

Conditions

Asthma; COPD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

broccoli sprout extract

Intervention Type: DRUG

consumption of broccoli sprout extract for 2 weeks

Interventions

broccoli sprout extract

consumption of broccoli sprout extract for 2 weeks

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Robert Brown

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Medical Institutions

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

RB-001

Identifier Type: -

Identifier Source: org_study_id