Allergic Rhinitis, Allergy, Asthma
Conditions
Keywords
asthma, allergic rhinitis, dietary interventions, mouse allergy
Brief summary
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.
Interventions
DRUGBroccoli Sprouts
100g of either broccoli or alfalfa sprouts will be eaten daily in a sandwich or wrap form.
DRUGPlacebo
Alfalfa Sprouts
Sponsors
National Institute of Environmental Health Sciences (NIEHS)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exhaled Nitric Oxide Concentrations | at 3 days | exhaled nitric oxide concentrations |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Broccoli Sprouts | 20 |
| Alfalfa Sprouts (Placebo Control) | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Broccoli Sprouts | Alfalfa Sprouts (Placebo Control) | Total |
|---|---|---|---|
| Age, Continuous | 33.1 years STANDARD_DEVIATION 9.6 | 34.2 years STANDARD_DEVIATION 9.2 | 33.6 years STANDARD_DEVIATION 9.4 |
| Gender Female | 11 Participants | 13 Participants | 24 Participants |
| Gender Male | 9 Participants | 7 Participants | 16 Participants |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Exhaled Nitric Oxide Concentrations
exhaled nitric oxide concentrations
Time frame: at 3 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alfalfa Sprouts (Placebo Control) | Exhaled Nitric Oxide Concentrations | 22 ppb |
| Broccoli Sprouts | Exhaled Nitric Oxide Concentrations | 19 ppb |