Effects of Whole Sprouts on Upper Airway Allergic Inflammation
| Status: | Completed |
|---|---|
| Conditions: | Allergy, Asthma, Neurology |
| Therapuetic Areas: | Neurology, Otolaryngology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/21/2016 |
| Start Date: | March 2012 |
| End Date: | March 2015 |
Dietary Interventions and Asthma Treatment: A Pilot Study of the Effects of Whole Sprouts on Upper Airway Allergic Inflammation
The primary objective of this study is to determine if broccoli sprouts (BS) improves nasal
inflammatory, oxidative stress (OS), and symptom responses to nasal mouse allergen challenge
(NAC) in mouse-sensitized adults perennial allergic rhinitis.
The study is a double-blind, placebo-controlled, randomized trial to compare BS to placebo
in 24 mouse-sensitized adults with asthma or perennial rhinitis and who develop rhinitis
symptoms with nasal mouse allergen challenge. Twenty-four adults (age 18-50) who meet these
eligibility criteria will be randomized to receive either: (a) BS or (b) placebo. At the
baseline NAC, FENO, FEV1, nasal epithelial gene expression, urinary OS biomarkers, serum
inflammatory and OS biomarkers, basophil activation, and symptoms will be assessed both
before and after NAC to establish pre-intervention responses to NAC. Subjects will eat a
sprouts sandwich daily for three days, and then undergo repeat NAC that includes measurement
of the above outcomes both before and after NAC.
inflammatory, oxidative stress (OS), and symptom responses to nasal mouse allergen challenge
(NAC) in mouse-sensitized adults perennial allergic rhinitis.
The study is a double-blind, placebo-controlled, randomized trial to compare BS to placebo
in 24 mouse-sensitized adults with asthma or perennial rhinitis and who develop rhinitis
symptoms with nasal mouse allergen challenge. Twenty-four adults (age 18-50) who meet these
eligibility criteria will be randomized to receive either: (a) BS or (b) placebo. At the
baseline NAC, FENO, FEV1, nasal epithelial gene expression, urinary OS biomarkers, serum
inflammatory and OS biomarkers, basophil activation, and symptoms will be assessed both
before and after NAC to establish pre-intervention responses to NAC. Subjects will eat a
sprouts sandwich daily for three days, and then undergo repeat NAC that includes measurement
of the above outcomes both before and after NAC.
Inclusion Criteria:
- Perennial rhinitis or doctor diagnosis of asthma
- Positive mouse skin test or specific IgE
- Non-smoker
- Negative pregnancy test
- Not breastfeeding
- Normal TSH
- For women, abstinent or using reliable birth control
- Age 18-50 years
- No other major pulmonary disease such as cystic fibrosis or COPD
- Willingness to participate in study and sign consent form
Exclusion Criteria:
- Severe or unstable asthma defined as requiring hospitalization in the previous 6
months or intubation in the previous 2 years, or on high-dose inhaled corticosteroids
or chronic oral corticosteroids
- Uncontrolled asthma defined as short-acting beta agonist use 3 or more days a week in
the previous 4 weeks
- A history of anaphylaxis or hospitalization due to mouse exposure
- FEV1 <80% predicted
- Other significant medical issues such as heart disease or poorly controlled
hypertension, type 1 diabetes, poorly controlled type 2 diabetes, or hypothyroidism
- Pregnancy or nursing/breastfeeding mothers
- On beta-blocker therapy
- On reserpine, clonidine, imipramine, or related tricyclic drugs
- Taking anti-oxidant supplements
- Planned dietary changes during the study period
- Unable to stop antihistamines prior to skin testing
- Unable to stop medications that may interfere with nasal challenge responses prior to
challenges
- Food allergy to Broccoli Sprouts or Alfalfa Sprouts
- Omalizumab use within the last 12 months
- Nasal polyps
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