Broccoli Sprout Extract Effects on Allergic Inflammation in the Nose

NCT00882115 | Completed Results DMC

• 1 other identifier: DAIT AADCRC-UCLA-01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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).

Conditions

Allergic Airway Disease

Keywords

DEP; Broccoli Sprout Extract; Allergies

Outcome Measures

Primary Outcomes (1)

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

  0, 6 and 24 hours at Control visit and BSE visit (Day 4 of intervention)

Study Arms (1)

DEP challenge in subjects consuming BSE

EXPERIMENTAL

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)

Interventions

Broccoli sprout extract (BSE) DRUG

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.

Also known as: Sulforaphane

DEP challenge in subjects consuming BSE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

Related Publications (5)

• 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. No abstract available.

  PMID: 19164194 BACKGROUND

• 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.

  PMID: 18310317 BACKGROUND

• 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.

  PMID: 19165401 BACKGROUND

• 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.

  PMID: 19164188 BACKGROUND

• Heber D, Li Z, Garcia-Lloret M, Wong AM, Lee TY, Thames G, Krak M, Zhang Y, Nel A. Sulforaphane-rich broccoli sprout extract attenuates nasal allergic response to diesel exhaust particles. Food Funct. 2014 Jan;5(1):35-41. doi: 10.1039/c3fo60277j.

  PMID: 24287881 RESULT

MeSH Terms

Conditions

Hypersensitivity

Interventions

sulforaphane

Condition Hierarchy (Ancestors)

Immune System Diseases

Limitations and 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.

Results Point of Contact

• Title: Zhaoping Li
• Organization: UCLA Department of Medicine/Center for Human Nutrition

zli@mednet.ucla.edu

310-206-1987

Study Officials

• David Heber, MD, PhD

  University of California, Los Angeles

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Study Record Dates

• First Submitted: April 14, 2009
• First Posted: April 16, 2009
• Study Start: July 10, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 20, 2019
• Results First Posted: November 15, 2018

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)