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Effects of Whole Sprouts on Airway Allergic Inflammation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01522703
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : January 19, 2017
Last Update Posted : January 19, 2017
Sponsor:
Collaborator:
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
Elizabeth Matsui, Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Allergic Rhinitis
Asthma
Allergy
Interventions Drug: Broccoli Sprouts
Drug: Placebo
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Broccoli Sprouts Alfalfa Sprouts (Placebo Control)
Hide Arm/Group Description ingestion of broccoli sprouts 3 consecutive days ingestion of alfalfa sprouts 3 consecutive days
Period Title: Overall Study
Started 25 26
Completed 20 20
Not Completed 5 6
Arm/Group Title Broccoli Sprouts Alfalfa Sprouts (Placebo Control) Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
33.1  (9.6) 34.2  (9.2) 33.6  (9.4)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
11
  55.0%
13
  65.0%
24
  60.0%
Male
9
  45.0%
7
  35.0%
16
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Exhaled Nitric Oxide Concentrations
Hide Description exhaled nitric oxide concentrations
Time Frame at 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alfalfa Sprouts (Placebo Control) Broccoli Sprouts
Hide Arm/Group Description:
ingestion of alfalfa sprouts for 3 consecutive days
ingestion of broccoli sprouts for 3 consecutive days
Overall Number of Participants Analyzed 20 20
Median (Inter-Quartile Range)
Unit of Measure: ppb
22
(12 to 32)
19
(15 to 43)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Broccoli Sprouts Alfalfa Sprouts (Placebo Control)
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Broccoli Sprouts Alfalfa Sprouts (Placebo Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Broccoli Sprouts Alfalfa Sprouts (Placebo Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Broccoli Sprouts Alfalfa Sprouts (Placebo Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (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
Layout table for Results Point of Contact information
Name/Title: Elizabeth Matsui, MD MHS
Organization: Johns Hopkins University School of Medicine
Phone: 410-502-3858
EMail: ematsui@jhmi.edu
Layout table for additonal information
Responsible Party: Elizabeth Matsui, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01522703    
Other Study ID Numbers: NA_00067371
1P01ES018176-01 ( U.S. NIH Grant/Contract )
First Submitted: January 9, 2012
First Posted: February 1, 2012
Results First Submitted: August 8, 2016
Results First Posted: January 19, 2017
Last Update Posted: January 19, 2017