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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
Sponsor:
Information provided by (Responsible Party):
Robert Brown, Johns Hopkins University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Asthma
COPD
Intervention Drug: broccoli sprout extract
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Broccoli Sprout Extract
Hide Arm/Group Description pre- and post-consumption of broccoli sprout extract for 2 weeks
Period Title: Overall Study
Started 51
Completed 45
Not Completed 6
Arm/Group Title Broccoli Sprout Extract
Hide Arm/Group Description broccoli sprout extract: consumption of broccoli sprout extract for 2 weeks
Overall Number of Baseline Participants 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants
38  (13)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
Female
29
  56.9%
Male
22
  43.1%
1.Primary Outcome
Title The Primary Outcome is the Change in Bronchodilation and Bronchoprotection After Broccoli Sprout Extract
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Broccoli Sprout Extract - BP Broccoli Sprout Extract - BD
Hide Arm/Group Description:
pre- and post-consumption of broccoli sprout extract for 2 weeks
pre- and post-consumption of broccoli sprout extract for 2 weeks
Overall Number of Participants Analyzed 45 45
Mean (Standard Deviation)
Unit of Measure: index
10.3  (57.1) 26.7  (30.6)
2.Secondary Outcome
Title Changes in Airway Size by Computed Tomography
Hide Description Changes in size airways as measured by computed tomography
Time Frame baseline and after two weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Airway Size Pre BSE Airway Size Post BSE
Hide Arm/Group Description:
CT scan measurements of changes in luminal area with BSE treatment measured at either total lung capacity (TLC) or functional residual capacity (FRC) (mean ± SD).
CT scan measurements of changes in luminal area with BSE treatment measured at either total lung capacity (TLC) or functional residual capacity (FRC) (mean ± SD).
Overall Number of Participants Analyzed 45 45
Mean (Standard Deviation)
Unit of Measure: size in mm^2
30.9  (1.8) 32  (4.5)
Time Frame entire study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Broccoli Sprout Extract
Hide Arm/Group Description pre- and post-consumption of broccoli sprout extract for 2 weeks
All-Cause Mortality
Broccoli Sprout Extract
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Broccoli Sprout Extract
Affected / at Risk (%)
Total   0/51 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Broccoli Sprout Extract
Affected / at Risk (%)
Total   0/51 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Robert Brown
Organization: Johns Hokpins Medical Institutions
Phone: 410-614-5451
Responsible Party: Robert Brown, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00994604     History of Changes
Other Study ID Numbers: RB-001
First Submitted: October 13, 2009
First Posted: October 14, 2009
Results First Submitted: August 9, 2016
Results First Posted: January 27, 2017
Last Update Posted: January 27, 2017