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Effects of Whole Sprouts on Airway Allergic Inflammation

This study has been completed.
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
Elizabeth Matsui, Johns Hopkins University Identifier:
First received: January 9, 2012
Last updated: November 24, 2016
Last verified: October 2016

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.

Condition Intervention
Allergic Rhinitis Asthma Allergy Drug: Broccoli Sprouts Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Dietary Interventions and Asthma Treatment: A Pilot Study of the Effects of Whole Sprouts on Airway Allergic Inflammation

Resource links provided by NLM:

Further study details as provided by Elizabeth Matsui, Johns Hopkins University:

Primary Outcome Measures:
  • Exhaled Nitric Oxide Concentrations [ Time Frame: at 3 days ]
    exhaled nitric oxide concentrations

Enrollment: 51
Study Start Date: March 2012
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Broccoli Sprouts
Broccoli Sprout sandwich/wrap will be eaten daily for 3 consecutive days
Drug: Broccoli Sprouts
100g of either broccoli or alfalfa sprouts will be eaten daily in a sandwich or wrap form.
Other Name: sprouts, broccoli sprouts
Placebo Comparator: Alfalfa Sprouts
Alfalfa Sprouts will be eaten daily in a sandwich form for 3 consecutive days
Drug: Placebo
Alfalfa Sprouts
Other Name: sprouts, alfalfa, broccoli sprouts


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01522703

United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21202
Sponsors and Collaborators
Johns Hopkins University
National Institute of Environmental Health Sciences (NIEHS)
Principal Investigator: Elizabeth Matsui, MD, MHS Johns Hopkins University
  More Information

Responsible Party: Elizabeth Matsui, Associate Professor, Johns Hopkins University Identifier: NCT01522703     History of Changes
Other Study ID Numbers: NA_00067371
1P01ES018176-01 ( U.S. NIH Grant/Contract )
Study First Received: January 9, 2012
Results First Received: August 8, 2016
Last Updated: November 24, 2016

Keywords provided by Elizabeth Matsui, Johns Hopkins University:
allergic rhinitis
dietary interventions
mouse allergy

Additional relevant MeSH terms:
Rhinitis, Allergic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Pathologic Processes
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases processed this record on September 21, 2017