Effects of Whole Sprouts on Airway Allergic Inflammation

Study Overview
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Brief Summary
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The primary objective of this study is to determine if broccoli sprouts (BS) improves airway inflammatory, oxidative stress (OS), and symptoms among asthmatic adults with aeroallergen sensitization. The study is a double-blind, placebo-controlled, randomized trial to compare BS to placebo in 40 adults with asthma. 40 adults (age 18-50) who meet these eligibility criteria will be randomized to receive either: (a) BS or (b) placebo (alfalfa sprouts). Subjects will eat a sprouts sandwich daily for three days, and then undergo repeat measurement of outcomes.

Official Title
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Dietary Interventions and Asthma Treatment: A Pilot Study of the Effects of Whole Sprouts on Airway Allergic Inflammation

Conditions
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Allergic Rhinitis, Asthma, Allergy

Intervention / Treatment
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* Drug: Broccoli Sprouts
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: doctor diagnosis of asthma aeroallergen sensitization 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 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 Food allergy to Broccoli Sprouts or Alfalfa Sprouts Omalizumab use within the last 12 months Nasal polyps

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Broccoli Sprouts<br>Broccoli Sprout sandwich/wrap will be eaten daily for 3 consecutive days | Drug: Broccoli Sprouts<br>* 100g of either broccoli or alfalfa sprouts will be eaten daily in a sandwich or wrap form.<br>* Other names: sprouts, broccoli sprouts;|
| Placebo Comparator: Alfalfa Sprouts<br>Alfalfa Sprouts will be eaten daily in a sandwich form for 3 consecutive days | Drug: Placebo<br>* Alfalfa Sprouts<br>* Other names: sprouts, alfalfa, broccoli sprouts;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled Nitric Oxide Concentrations | exhaled nitric oxide concentrations | at 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, allergic rhinitis, dietary interventions, mouse allergy