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
Last Update Posted : May 8, 2017
|Condition or disease||Intervention/treatment|
|Allergic Airway Disease||Drug: BSE Extract|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|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 :||August 2009|
|Primary Completion Date :||December 2011|
|Study Completion Date :||December 2011|
Experimental: Participants w/wo DEP sensitivity
BSE 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 for subjects with and without DEP sensitivity
Drug: BSE 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
Other Name: Sulforaphane
- Increased total nasal cell count at 6 and 24 hours. [ Time Frame: 6 weeks ]After 4 days of drinking broccoli sprout extract, DEP response was attenuated in responders at 6 hours and 24 hours compared to the screen and control phases. Cell count change from baseline as a percentage *(p < 0.01 comparing with screen or control phase).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00882115
|United States, California|
|Los Angeles, California, United States, 90095|
|Study Chair:||David Heber, MD, PhD||UCLA Department of Medicine|