Trial Outcomes & Findings for The Effects of Broccoli Sprout Extract on Obstructive Lung Disease (NCT NCT00994604)

NCT ID: NCT00994604

Last Updated: 2017-01-27

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 51 participants
• Primary outcome timeframe: baseline and two weeks
• Results posted on: 2017-01-27

Participant Flow

Participant milestones

Measure	Broccoli Sprout Extract pre- and post-consumption of broccoli sprout extract for 2 weeks
Overall Study STARTED	51
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Broccoli Sprout Extract on Obstructive Lung Disease

Baseline characteristics by cohort

Measure	Broccoli Sprout Extract n=51 Participants broccoli sprout extract: consumption of broccoli sprout extract for 2 weeks
Age, Continuous	38 years STANDARD_DEVIATION 13 • n=5 Participants
Gender Female	29 Participants n=5 Participants
Gender Male	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Broccoli Sprout Extract - BP n=45 Participants pre- and post-consumption of broccoli sprout extract for 2 weeks	Broccoli Sprout Extract - BD n=45 Participants pre- and post-consumption of broccoli sprout extract for 2 weeks
The Primary Outcome is the Change in Bronchodilation and Bronchoprotection After Broccoli Sprout Extract	10.3 index Standard Deviation 57.1	26.7 index Standard Deviation 30.6

SECONDARY outcome

Timeframe: baseline and after two weeks

Changes in size airways as measured by computed tomography

Outcome measures

Measure	Broccoli Sprout Extract - BP n=45 Participants pre- and post-consumption of broccoli sprout extract for 2 weeks	Broccoli Sprout Extract - BD n=45 Participants pre- and post-consumption of broccoli sprout extract for 2 weeks
Changes in Airway Size by Computed Tomography	30.9 size in mm^2 Standard Deviation 1.8	32 size in mm^2 Standard Deviation 4.5

Adverse Events

Broccoli Sprout Extract

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Brown

Johns Hokpins Medical Institutions

Phone: 410-614-5451

Email: rbrown2@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place