The Effects of Broccoli Sprout Extract on Obstructive Lung Disease

NCT00994604 | Completed Results

• 1 other identifier: RB-001
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; COPD

Outcome Measures

Primary Outcomes (1)

• 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

  baseline and two weeks

Secondary Outcomes (1)

• Changes in Airway Size by Computed Tomography

  baseline and after two weeks

Study Arms (1)

broccoli sprout extract

EXPERIMENTAL

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

Interventions

broccoli sprout extract DRUG

consumption of broccoli sprout extract for 2 weeks

broccoli sprout extract

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• asthma
• COPD

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Robert Brown
• Organization: Johns Hokpins Medical Institutions

rbrown2@jhmi.edu

410-614-5451

Study Officials

• Robert Brown, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 13, 2009
• First Posted: October 14, 2009
• Study Start: October 1, 2009
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 27, 2017
• Results First Posted: January 27, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)