N/A
N=51
Effects of Whole Sprouts on Airway Allergic Inflammation
Allergic Rhinitis · Asthma · Allergy
Bottom Line
View on ClinicalTrials.gov: NCT01522703 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Exhaled Nitric Oxide Concentrations — 22; 19 ppb
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Broccoli Sprouts (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exhaled Nitric Oxide Concentrations |
22; 19 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01522703). 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.