Dietary Interventions in Asthma Treatment: Sprouts Study

• ClinicalTrials.gov Identifier: NCT01183923
• Recruitment Status: Terminated
• First Posted: August 18, 2010
• Results First Posted: June 4, 2019
• Last Update Posted: June 4, 2019
• Sponsor: Johns Hopkins University
• Collaborators: National Institutes of Health (NIH); National Institute of Environmental Health Sciences (NIEHS); Massachusetts General Hospital
• Information provided by (Responsible Party): Johns Hopkins University

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Conditions: Asthma; Allergy
• Interventions: Other: Broccoli Sprouts; Other: Alfalfa Sprouts
• Enrollment: 1

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Broccoli Sprouts, Then Alfalfa Sprouts	Alfalfa Sprouts, Then Broccoli Sprouts
Arm/Group Description	Broccoli Sprouts will be eaten daily in a sandwich form, followed by a 14 day washout, and then alfalfa sprouts will be eaten daily in a sandwich form.	Alfalfa sprouts will be eaten daily in a sandwich form, followed by a 14 day washout, and then broccoli sprouts will be eaten daily in a sandwich form.
Period Title: Intervention 1 (7 Days)
Started	1	0
Completed	1	0
Not Completed	0	0
Period Title: Washout (14 Days)
Started	1	0
Completed	1	0
Not Completed	0	0
Period Title: Intervention 2 (7 Days)
Started	1	0
Completed	1	0
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		All Participants
Arm/Group Description		the study population will be randomized in a 1:1 ratio to first eat broccoli sprouts followed by a washout period and then eat alfalfa sprouts, or to start with alfalfa sprouts followed by a washout and then eat broccoli sprouts
Overall Number of Baseline Participants		1
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	1 100.0%
	>=65 years	0 0.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1 participants
	Female	0 0.0%
	Male	1 100.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	0 0.0%
	White	1 100.0%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	1 participants
		1 100.0%

Outcome Measures

1. Primary Outcome

Title	Change in Forced Expiratory Volume at One Second (FEV1)
Description	The percentage change in FEV1 from the pre-challenge FEV1 value over the 1 hour mouse chamber exposure.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Trial was halted due to an adverse event after the second intervention. The participant could not complete the second challenge for data to be obtained.

Arm/Group Title	Broccoli Sprouts	Alfalfa Sprouts
Arm/Group Description:	Broccoli Sprouts: Broccoli Sprouts will be eaten daily in a sandwich form followed by a washout period, after which alfalfa sprouts will be eaten in a sandwich form.	Participants who received alfalfa sprouts
Overall Number of Participants Analyzed	1	0
Measure Type: Number; Unit of Measure: percent change
	-18

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Total Study Population
Arm/Group Description	Total population, which is randomized 1:1 to broccoli sprouts, then alfalfa sprouts or alfalfa sprouts, then broccoli sprouts
All-Cause Mortality
	Total Study Population
	Affected / at Risk (%)
Total	0/1 (0.00%)
Serious Adverse Events
	Total Study Population
	Affected / at Risk (%)	# Events
Total	1/1 (100.00%)
Respiratory, thoracic and mediastinal disorders
bronchospasm †	1/1 (100.00%)	1
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Total Study Population
	Affected / at Risk (%)	# Events
Total	0/1 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

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: Elizabeth Matsui, MD MHS
• Organization: Johns Hopkins University School of Medicine
• Phone: 410-502-3858
• EMail: ematsui@jhmi.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sudini K, Diette GB, Breysse PN, McCormack MC, Bull D, Biswal S, Zhai S, Brereton N, Peng RD, Matsui EC. A Randomized Controlled Trial of the Effect of Broccoli Sprouts on Antioxidant Gene Expression and Airway Inflammation in Asthmatics. J Allergy Clin Immunol Pract. 2016 Sep-Oct;4(5):932-40. doi: 10.1016/j.jaip.2016.03.012. Epub 2016 Apr 27.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01183923
• Other Study ID Numbers: NA_00035087; 1P01ES018176-01 ( U.S. NIH Grant/Contract )
• First Submitted: August 17, 2010
• First Posted: August 18, 2010
• Results First Submitted: April 28, 2016
• Results First Posted: June 4, 2019
• Last Update Posted: June 4, 2019