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Dietary Interventions in Asthma Treatment: Sprouts Study

This study has suspended participant recruitment.
(reworking protocol)
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Massachusetts General Hospital
Information provided by (Responsible Party):
Elizabeth Matsui, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01183923
First received: August 17, 2010
Last updated: March 28, 2012
Last verified: March 2012
History of Changes
  Purpose

Sulforaphane (SFN) is a naturally occurring isothiocyanate that is a potent inducer of Phase II enzymes which play a critical role in preventing oxidative stress (via activation of Nrf2). Broccoli sprouts (BS) contain the richest source of SFN.

The main objectives of this study are to test the effect of broccoli sprouts (BS) on biomarkers of oxidative stress (OS), inflammation, basophil activation, and clinical outcomes in mouse allergen-induced asthma by (1) determining if BS improves lung function and airways symptom responses in mouse-sensitized adults with asthma undergoing environmental mouse allergen challenge (EMAC), (2) examining the effect of BS on OS, inflammation, and basophil activation, and (3) examining the effect of BS on changes in OS, inflammation, and basophil activation after EMAC.


Condition Intervention Phase
Asthma
Allergy
 Other: Broccoli Sprouts
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dietary Interventions in Asthma Treatment: Sprouts Study

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma
U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Forced expiratory volume in one second (FEV1) [ Time Frame: after 7 days of treatment ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: November 2010
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Broccoli Sprouts, then Alfalfa Sprouts Other: Broccoli Sprouts
Broccoli Sprouts will be eaten daily in a sandwich form.
Alfalfa Sprouts, then Broccoli Sprouts Other: Broccoli Sprouts
Broccoli Sprouts will be eaten daily in a sandwich form.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-49 years
  • Physician-diagnosed asthma
  • No other major pulmonary disease such as cystic fibrosis or COPD
  • Mouse sensitization, defined by a positive skin prick test to mouse epithelial extract or positive mouse-specific IgE
  • Non-smoker

Exclusion Criteria:

  • Severe or unstable asthma defined as requiring hospitalization in the previous year or intubation in the previous 2 years, or on high-dose inhaled corticosteroids or chronic oral corticosteroids
  • Baseline FEV1 and FEV1/FVC < 70% predicted
  • Positive SPT to a pet currently living in the participant's home
  • Other significant medical issues such as heart disease or poorly controlled hypertension, or hypothyroidism
  • Pregnancy or nursing/breastfeeding mothers
  • On beta-blocker therapy
  • Taking anti-oxidant supplements
  • Unable to stop antihistamines prior to skin testing
  • Unable to stop medications that may interfere with allergen challenge responses prior to challenges.
  • The participant has food allergy to BS or AS.
  • Omalizumab use within the last 12 months.
  • Oral corticosteroid use within the last 2 weeks.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183923

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
National Institutes of Health (NIH)
Massachusetts General Hospital
Investigators
Principal Investigator: Elizabeth C Matsui, MD MHS Johns Hopkins University
  More Information

No publications provided

Responsible Party: Elizabeth Matsui, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01183923     History of Changes
Other Study ID Numbers: NA_00035087
Study First Received: August 17, 2010
Last Updated: March 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
asthma
dietary interventions
mouse allergy

Additional relevant MeSH terms:
Hypersensitivity
Asthma
Immune System Diseases
Bronchial Diseases
Respiratory Tract Diseases
 Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on May 16, 2013