Broccoli Sprout Extract Effects on Allergic Inflammation in the Nose

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT00882115
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arm: 1
• Duration (Months): 28.7
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Allergic Airway Disease	Drug: Broccoli sprout extract (BSE)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Broccoli Sprout Extract Effects on the Inflammatory Response to Diesel Exhaust Particles in the Nose
• Study Start Date: Jul 10, 2009
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.	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 Names: Sulforaphane

Outcome Measures

Primary Outcome Measures

1. Total Nasal Cell Count in Response to DEP Challenge at 0, 6 and 24 hr With or Without BSE Intervention [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA	Los Angeles	California	United States	90095

Sponsors and Collaborators

• University of California, Los Angeles

Investigators

• Study Chair: David Heber, MD, PhD, UCLA Department of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

• Krewski D. Evaluating the effects of ambient air pollution on life expectancy. N Engl J Med. 2009 Jan 22;360(4):413-5. doi: 10.1056/NEJMe0809178.
• Munday R, Mhawech-Fauceglia P, Munday CM, Paonessa JD, Tang L, Munday JS, Lister C, Wilson P, Fahey JW, Davis W, Zhang Y. Inhibition of urinary bladder carcinogenesis by broccoli sprouts. Cancer Res. 2008 Mar 1;68(5):1593-600. doi: 10.1158/0008-5472.CAN-07-5009. Epub 2008 Feb 29.
• Parker JD, Akinbami LJ, Woodruff TJ. Air pollution and childhood respiratory allergies in the United States. Environ Health Perspect. 2009 Jan;117(1):140-7. doi: 10.1289/ehp.11497. Epub 2008 Sep 30.
• Pope CA 3rd, Ezzati M, Dockery DW. Fine-particulate air pollution and life expectancy in the United States. N Engl J Med. 2009 Jan 22;360(4):376-86. doi: 10.1056/NEJMsa0805646.

• Responsible Party: Zhaoping Li, Professor of Clinical Medicine, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT00882115
• Other Study ID Numbers: DAIT AADCRC-UCLA-01
• First Posted: Apr 16, 2009
• Last Update Posted: Sep 20, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Zhaoping Li, Professor of Clinical Medicine, University of California, Los Angeles: DEP; Broccoli Sprout Extract; Allergies
• Additional relevant MeSH terms: Sulforaphane

Study Results

Participant Flow

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 Detail	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.
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

Baseline Characteristics

Arm/Group Title	DEP Challenge in Subjects Consuming BSE
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 Participants	29
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	29 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	15 51.7%
Male	14 48.3%
Region of Enrollment (Count of Participants)
United States	29 100%

Outcome Measures

1. Primary Outcome

Title	Total Nasal Cell Count in Response to DEP Challenge at 0, 6 and 24 hr With or Without BSE Intervention
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)

Outcome Measure Data

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
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
Measure Participants	29
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)

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
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANOVA
	Comments	Data followed the normal distribution, therefore, a parametric repeated measure (mixed model) ANOVA model was used to compare means.

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
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	ANOVA
	Comments	Data followed the normal distribution, therefore, a parametric repeated measure (mixed model) ANOVA model was used to compare means.

Adverse Events

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
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Cell Count Change in Response to Nasal DEP Challenge
	Affected / at Risk (%)	# Events
Total	5/38 (13.2%)
Gastrointestinal disorders
mild discomfort	5/38 (13.2%)	8
Other (Not Including Serious) Adverse Events
	Cell Count Change in Response to Nasal DEP Challenge
	Affected / at Risk (%)	# Events
Total	4/38 (10.5%)
Skin and subcutaneous tissue disorders
nasal irritation, running nose	4/38 (10.5%)	7

Limitations/Caveats

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.

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.