Broccoli Sprout Extract Effects on Allergic Inflammation in the Nose
Condition: Allergic Airway Disease
Study type: Interventional

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.
    

Intervention name(s): Broccoli sprout extract (BSE)
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): Sulforaphane
Intervention MeSH terms: Sulforaphane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: DEP; Broccoli Sprout Extract; Allergies