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Dietary Interventions in Asthma Treatment: Sprouts Study

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ClinicalTrials.gov Identifier: NCT01183923
Recruitment Status : Terminated
First Posted : August 18, 2010
Results First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Environmental Health Sciences (NIEHS)
Massachusetts General Hospital
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

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 or disease Intervention/treatment Phase
Asthma Allergy Other: Broccoli Sprouts Other: Alfalfa Sprouts Not Applicable

Detailed Description:
After eligibility is confirmed, participants will be randomized to (a) placebo then BS or (b) BS then placebo. At randomization, baseline exhaled nitric oxide (eNO), forced expiratory volume at one second (FEV1), nasal epithelial gene expression, urinary OS biomarkers, serum inflammatory and OS biomarkers, and basophil activation will be assessed. These will be assessed again after 7 days on the assigned intervention at two time points: pre- and post-EMAC. The 1 week time period was chosen because previous studies have shown that daily ingestion of a broccoli sprout homogenate for three days resulted in upregulation of phase II enzyme gene expression in nasal epithelial cells. Following a 2-week washout period, this protocol will be repeated for the second intervention, phase II. The 2 week washout period will be sufficient as the half life of the extract of the active ingredient in broccoli sprouts, SFN, has been shown to be 1.8 hours.(16) Participants' diets will be assessed before and after each intervention with a Food Frequency Questionnaire and a questionnaire to capture intake of specific foods that are rich in SFN.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dietary Interventions in Asthma Treatment: Sprouts Study
Study Start Date : November 2010
Actual Primary Completion Date : February 6, 2012
Actual Study Completion Date : February 6, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Broccoli Sprouts, then Alfalfa Sprouts
Broccoli Sprout sandwich/wrap will be eaten daily for 7 consecutive days followed by alfalfa sprouts after washout.
Other: Broccoli Sprouts
Broccoli Sprouts will be eaten daily in a sandwich form during the intervention period for broccoli sprouts.

Other: Alfalfa Sprouts
Alfalfa sprouts will be eaten daily in a sandwich form during the intervention period for alfalfa sprouts.

Experimental: Alfalfa Sprouts, then Broccoli Sprouts
Alfalfa Sprout sandwich/wrap will be eaten daily for 7 consecutive days followed by broccoli sprouts after washout.
Other: Broccoli Sprouts
Broccoli Sprouts will be eaten daily in a sandwich form during the intervention period for broccoli sprouts.

Other: Alfalfa Sprouts
Alfalfa sprouts will be eaten daily in a sandwich form during the intervention period for alfalfa sprouts.




Primary Outcome Measures :
  1. Change in Forced Expiratory Volume at One Second (FEV1) [ Time Frame: 30 days ]
    The percentage change in FEV1 from the pre-challenge FEV1 value over the 1 hour mouse chamber exposure.



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-49 years
  • Physician-diagnosed asthma
  • No other major pulmonary disease such as cystic fibrosis or chronic obstructive pulmonary disease (COPD)
  • Mouse sensitization, defined by a positive skin prick test to mouse epithelial extract or positive mouse-specific immunoglobulin E (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/forced vital capacity (FVC) < 70% predicted
  • Positive skin prick test (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01183923


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
National Institutes of Health (NIH)
National Institute of Environmental Health Sciences (NIEHS)
Massachusetts General Hospital
Investigators
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Principal Investigator: Elizabeth C Matsui, MD MHS Johns Hopkins University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01183923    
Other Study ID Numbers: NA_00035087
1P01ES018176-01 ( U.S. NIH Grant/Contract )
First Posted: August 18, 2010    Key Record Dates
Results First Posted: June 4, 2019
Last Update Posted: June 4, 2019
Last Verified: May 2019
Keywords provided by Johns Hopkins University:
asthma
dietary interventions
mouse allergy
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases