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

Tracking Information
First Submitted Date  ICMJE April 14, 2009
First Posted Date  ICMJE April 16, 2009
Results First Submitted Date  ICMJE August 11, 2017
Results First Posted Date  ICMJE November 15, 2018
Last Update Posted Date September 20, 2019
Study Start Date  ICMJE July 10, 2009
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
Total Nasal Cell Count in Response to DEP Challenge at 0, 6 and 24 hr With or Without BSE Intervention [ Time Frame: 0, 6 and 24 hours at Control visit and BSE visit (Day 4 of intervention) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2009)
Inhibition of mucosal inflammatory cells in nasal lavage [ Time Frame: At 24 hours after DEP nasal challenge ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2009)
  • Selected DEP-related cytokines and chemokines, as measured by an ELISA test [ Time Frame: At 6 and 24 hours after DEP nasal challenge ]
  • Phase II enzyme levels, as measured by RT-PCR [ Time Frame: Post DEP nasal challenge ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Broccoli Sprout Extract Effects on Allergic Inflammation in the Nose
Official Title  ICMJE Broccoli Sprout Extract Effects on the Inflammatory Response to Diesel Exhaust Particles in the Nose
Brief Summary Allergic airway disease is a term used to describe conditions such as allergic rhinitis and asthma. Among other causative agents, air pollutants and diesel exhaust in particular, have been shown to create and also worsen existing allergic airway disease. These inhaled pollution particles have oxidative properties that drive inflammation-related effects through specific metabolic-associated processes. These processes are not adequately suppressed by current therapeutics. The purpose of this study is to explore the effects of broccoli sprout extract on the inflammatory process in the nose caused by diesel exhaust particles, which are important elements in air pollution. Broccoli sprout extract is a very potent inducer of Phase II enzymes (natural antioxidants).
Detailed Description

Antioxidant enzymes are proteins produced by the body to protect cells against the harmful effects of chemicals, such as those found in air pollution. Particulate air pollution and diesel exhaust in particular have been shown to cause and also exacerbate allergic airway disease. While there are ongoing efforts to improve air quality, there remains a need for alternative methods to address and prevent the adverse health effects of ambient air pollution, such as allergic rhinitis,, asthma, chronic obstructive pulmonary disease, and lung cancer. Currently, there are no therapeutic options which, directly target and address the effects of air pollutants in susceptible populations.

The purpose of this study is to examine the effect of broccoli sprout extract on airway inflammation caused by diesel exhaust particles. This study will analyze whether broccoli sprout extract will increase the levels of the natural, helpful, antioxidant enzymes in the nose and as a result decrease the inflammation caused by nasal exposure to diesel exhaust particles.

Participants will attend up to ten clinical visits, which include three screening visits. Some visits (2, 4, and 9) will last approximately 1 hour and require that the participants return to the clinic after 6 hours. The remaining visits (excluding Visit 1, which will also last about 1 hour) will take less than 30 minutes. Participants are restricted from consuming certain vegetables three days prior to, and during the course of the study.

During the screening phase, which will last from 4-5 days, and after giving informed consent participants will undergo a baseline evaluation that includes a medical history, a physical exam, blood drawing, allergy skin testing, nose washing, and a diesel exhaust particle (DEP) challenge test. For the DEP test, a small amount of fluid containing DEP particles will be sprayed in the nose (this amount is equivalent to the DEP that one breathes in over 2 days in Los Angeles). Investigators will also screen for natural antioxidant-related genes antioxidant enzymes and other indicators of DEP sensitivity. Female participants of child bearing potential will have a urine pregnancy test.

Participants will be asked to drink broccoli sprout extract for four days in a row (visits 6, 7, 8, and 9). The dosage is less than 1 cup and requires that participants fast 2 hours before the study visits when broccoli sprout extract is ingested. This study requires that participants be allergic to cat. An allergy skin test will be performed to determine whether they have this kind of allergy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Allergic Airway Disease
Intervention  ICMJE Drug: Broccoli sprout extract (BSE)
BSE will be ingested by drinking a liquid formula containing 1.25 g BSE in a volume equaling 1 cup daily for 4 consecutive days in the BSE intervention phase.
Other Name: Sulforaphane
Study Arms  ICMJE Experimental: DEP challenge in subjects consuming BSE
DEP will be administered in nostrils of participants who received BSE intervention by drinking 1 cup of liquid containing 1.25 g BSE daily for 4 days, or without consuming BSE.
Intervention: Drug: Broccoli sprout extract (BSE)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2018)
38
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2009)
100
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able and willing to provide informed consent
  • DEP responder as defined in protocol
  • Ability to refrain from consuming cruciferous vegetables 3 days prior to starting study and while on study. Cruciferous vegetables include: Broccoli, Kale, Chard, Kohlrabi, Brussels Sprouts, Parsley, Watercress, Daikon, Cabbage, Rutabagas, Cauliflower, Bok Choy, Arugula, Turnips, Radish, Mustard and Collard greens.
  • Allergy skin test positive to cat
  • Nonsmoker or ex-smoker of more than one year

Exclusion Criteria:

  • Smoking within past year or during study
  • Systemic corticosteroid or other immunosuppressive medication use in the previous 3 months or during study
  • Intranasal corticosteroid use in the previous month or during the study
  • Intranasal antihistamine or cromolyn use in the previous week or during study
  • Allergen immunotherapy during the previous 12 months or during study
  • Omalizumab use in the previous 12 months or during study
  • Systemic antihistamine or leukotriene modifying medication use in the previous week or during study
  • History of asthma or any current medical condition that in the opinion of the investigator may compromise the subject's ability to safely participate in the study
  • Baseline abnormality of hemoglobin, platelets, leukocytes, serum chemistries, liver function testing, or presence of proteinuria
  • A finding during physical examination that, in the opinion of the investigator may compromise the participant's ability to safely participate in the study
  • Pregnant or breast-feeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00882115
Other Study ID Numbers  ICMJE DAIT AADCRC-UCLA-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to share IPD with other researchers.
Responsible Party Zhaoping Li, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: David Heber, MD, PhD UCLA Department of Medicine
PRS Account University of California, Los Angeles
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP