N/A
N=38
Broccoli Sprout Extract Effects on Allergic Inflammation in the Nose
Allergic Airway Disease
Bottom Line
View on ClinicalTrials.gov: NCT00882115 ↗Enrolled (actual)
38
Serious AEs
13.2%
Results posted
Nov 2018
Primary outcome: Primary: Total Nasal Cell Count in Response to DEP Challenge at 0, 6 and 24 hr With or Without BSE Intervention — 4.44; 4.50; 4.73; 4.70 log cells/mL — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Broccoli sprout extract (BSE) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Nasal Cell Count in Response to DEP Challenge at 0, 6 and 24 hr With or Without BSE Intervention |
4.44; 4.50; 4.73; 4.70; 4.44; 4.57 | <0.001 sig |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00882115). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.