Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Broccoli Sprout Extract Effects on Allergic Inflammation in the Nose

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: NCT00882115
Recruitment Status : Completed
First Posted : April 16, 2009
Results First Posted : November 15, 2018
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Zhaoping Li, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Allergic Airway Disease
Intervention Drug: Broccoli sprout extract (BSE)
Enrollment 38
Recruitment Details The enrollment period was 07/10/2009 - 11/09/2010. Enrollment took place in a private setting in the clinic located at the site.
Pre-assignment Details Thirty-eight participants who tested positive for cat allergy were enrolled. The study had three phases: screen, control and intervention. There was a 2-week run in and a 4-week wash out period. Six subjects who did not respond to DEP challenge at screen phase, and three subjects who withdrew from the study before intervention were excluded.
Arm/Group Title Cell Count Change in Response to Nasal DEP Challenge.
Hide Arm/Group Description Nasal cell count change in response to DEP challenge (300 microgram DEP in 200 microliter saline) in participants who received BSE by drinking 1 cup of liquid containing 1.25 g BSE daily for 4 days, or without consuming BSE.
Period Title: Overall Study
Started 38
Completed 29
Not Completed 9
Reason Not Completed
Withdrawal by Subject             3
did not respond to DEP challe             6
Arm/Group Title DEP Challenge in Subjects Consuming BSE
Hide Arm/Group Description DEP will be administered in nostrils of participants who receive BSE by drinking 1 cup of liquid containing 1.25 g BSE daily for 4 days, or without consuming BSE.
Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
<=18 years
0
   0.0%
Between 18 and 65 years
29
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
15
  51.7%
Male
14
  48.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 29 participants
29
 100.0%
1.Primary Outcome
Title Total Nasal Cell Count in Response to DEP Challenge at 0, 6 and 24 hr With or Without BSE Intervention
Hide Description Change of total nasal cell count in response to a standard diesel exhaust particle (DEP) challenge was determined by counting the total number of cells (leukocytes) recovered from nasal lavage fluid at 0 hr (just prior to DEP dosing), 6 hr and 24 hr later in participants who consuming BSE for 4 days, or without consuming BSE (control). Nasal challenges were performed with 300 microgram a standard DEP in 200 microliter saline.
Time Frame 0, 6 and 24 hours at Control visit and BSE visit (Day 4 of intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with baseline (0 hr), and 6 hr and 24 hr post-baseline nasal cell count measurement.
Arm/Group Title Nasal DEP Challenge
Hide Arm/Group Description:
All participants consumed 1.25 g BSE suspended in juice once a day for 4 consecutive days prior to dosing of 300 microg DEP in 200 microL saline
Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: log cells/mL
0 hr prior DEP dosing (control) 4.44  (0.51)
6 hr after DEP dosing (control) 4.50  (0.56)
24 hr after DEP dosing (control) 4.73  (0.52)
0 hr prior to DEP doising with BSE intervention 4.70  (0.54)
6 hr after DEP dosing with BSE intervention 4.44  (0.51)
24 hr after DEP dosing with BSE intervention 4.57  (0.46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nasal DEP Challenge
Comments Comparison was made to the 24 h minus baseline change in both control phase and intervention phase.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments Data followed the normal distribution, therefore, a parametric repeated measure (mixed model) ANOVA model was used to compare means.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nasal DEP Challenge
Comments Comparison waws made to the 6 hour minus baseline change in both control phase and intervention phase.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments Data followed the normal distribution, therefore, a parametric repeated measure (mixed model) ANOVA model was used to compare means.
Time Frame Adverse event data was collected over a 6 week period
Adverse Event Reporting Description Participants were monitored and questioned regarding the occurrence and nature of any adverse experiences.
 
Arm/Group Title Cell Count Change in Response to Nasal DEP Challenge
Hide Arm/Group Description Nasal cell count change in response to DEP challenge (300 microgram DEP in 200 microliter saline) in participants who received BSE by drinking 1 cup of liquid containing 1.25 g BSE daily for 4 days, or without consuming BSE.
All-Cause Mortality
Cell Count Change in Response to Nasal DEP Challenge
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Cell Count Change in Response to Nasal DEP Challenge
Affected / at Risk (%) # Events
Total   5/38 (13.16%)    
Gastrointestinal disorders   
mild discomfort * 1  5/38 (13.16%)  8
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, SNOMED CT
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cell Count Change in Response to Nasal DEP Challenge
Affected / at Risk (%) # Events
Total   4/38 (10.53%)    
Skin and subcutaneous tissue disorders   
nasal irritation, running nose * 1  4/38 (10.53%)  7
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, SNOMED CT
The study tested the hypothesis that sulforaphane in the broccoli sprout extract (BSE) will interfere in the generation of nasal inflammation by diesel exhaust particles (DEP) but more studies with larger sample size and more data are needed.
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: Zhaoping Li
Organization: UCLA Department of Medicine/Center for Human Nutrition
Phone: 310-206-1987
EMail: zli@mednet.ucla.edu
Layout table for additonal information
Responsible Party: Zhaoping Li, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00882115    
Other Study ID Numbers: DAIT AADCRC-UCLA-01
First Submitted: April 14, 2009
First Posted: April 16, 2009
Results First Submitted: August 11, 2017
Results First Posted: November 15, 2018
Last Update Posted: September 20, 2019