Trial Outcomes & Findings for Dietary Interventions in Asthma Treatment: Sprouts Study (NCT NCT01183923)

NCT ID: NCT01183923

Last Updated: 2019-06-04

Results Overview

The percentage change in FEV1 from the pre-challenge FEV1 value over the 1 hour mouse chamber exposure.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 1 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2019-06-04

Participant Flow

Participant milestones

Measure	Broccoli Sprouts, Then Alfalfa Sprouts 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, Then Broccoli Sprouts 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.
Intervention 1 (7 Days) STARTED	1	0
Intervention 1 (7 Days) COMPLETED	1	0
Intervention 1 (7 Days) NOT COMPLETED	0	0
Washout (14 Days) STARTED	1	0
Washout (14 Days) COMPLETED	1	0
Washout (14 Days) NOT COMPLETED	0	0
Intervention 2 (7 Days) STARTED	1	0
Intervention 2 (7 Days) COMPLETED	1	0
Intervention 2 (7 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dietary Interventions in Asthma Treatment: Sprouts Study

Baseline characteristics by cohort

Measure	All Participants n=1 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: 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.

The percentage change in FEV1 from the pre-challenge FEV1 value over the 1 hour mouse chamber exposure.

Outcome measures

Measure	Broccoli Sprouts n=1 Participants 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.	Alfalfa Sprouts Participants who received alfalfa sprouts
Change in Forced Expiratory Volume at One Second (FEV1)	-18 percent change	—

Adverse Events

Total Study Population

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Total Study Population n=1 participants at risk Total population, which is randomized 1:1 to broccoli sprouts, then alfalfa sprouts or alfalfa sprouts, then broccoli sprouts
Respiratory, thoracic and mediastinal disorders bronchospasm	100.0% 1/1 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Elizabeth Matsui, MD MHS

Johns Hopkins University School of Medicine

Phone: 410-502-3858

Email: ematsui@jhmi.edu

Results disclosure agreements

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