Broccoli Sprout Extract Effects on Allergic Inflammation in the Nose
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Broccoli Sprout Extract Effects on the Inflammatory Response to Diesel Exhaust Particles in the Nose|
- Inhibition of mucosal inflammatory cells in nasal lavage [ Time Frame: At 24 hours after DEP nasal challenge ] [ Designated as safety issue: No ]
- Selected DEP-related cytokines and chemokines, as measured by an ELISA test [ Time Frame: At 6 and 24 hours after DEP nasal challenge ] [ Designated as safety issue: No ]
- Phase II enzyme levels, as measured by RT-PCR [ Time Frame: Post DEP nasal challenge ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
|Experimental: Participants with and without DEP sensitivity||
Drug: Broccoli sprout extract
Broccoli sprout extract will be ingested by drinking a liquid formula in a volume equaling less than 1 cup at study Visits 6,7,8, and 9
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00882115
|United States, California|
|Los Angeles, California, United States|
|Study Chair:||David Heber, MD, PhD||UCLA Department of Medicine|