Effects of Whole Sprouts on Airway Allergic Inflammation

Not Applicable

Completed

• Conditions: Asthma; Allergy; Allergic Rhinitis
• Interventions: Drug: Broccoli Sprouts; Drug: Placebo

• Registration Number: NCT01522703
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-27
• Study First Posted: 2012-02-01
• Study Start: 2012-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Results First Submitted: 2016-08-08
• Status Verified: 2016-10
• Results First Submitted QC: 2016-11-24
• Last Update Submitted: 2016-11-24
• Results First Posted: 2017-01-19
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Broccoli Sprouts	Broccoli Sprouts	Broccoli Sprout sandwich/wrap will be eaten daily for 3 consecutive days
Alfalfa Sprouts	Placebo	Alfalfa Sprouts will be eaten daily in a sandwich form for 3 consecutive days

Primary Outcome Measures

Name	Time	Method
Exhaled Nitric Oxide Concentrations	at 3 days	exhaled nitric oxide concentrations

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States