Dietary Interventions in Asthma Treatment: Sprouts Study
Primary Purpose
Asthma, Allergy
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Broccoli Sprouts
Alfalfa Sprouts
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring asthma, dietary interventions, mouse allergy
Eligibility 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.
Sites / Locations
- Johns Hopkins University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Broccoli Sprouts, then Alfalfa Sprouts
Alfalfa Sprouts, then Broccoli Sprouts
Arm Description
Broccoli Sprout sandwich/wrap will be eaten daily for 7 consecutive days followed by alfalfa sprouts after washout.
Alfalfa Sprout sandwich/wrap will be eaten daily for 7 consecutive days followed by broccoli sprouts after washout.
Outcomes
Primary Outcome Measures
Change in Forced Expiratory Volume at One Second (FEV1)
The percentage change in FEV1 from the pre-challenge FEV1 value over the 1 hour mouse chamber exposure.
Secondary Outcome Measures
Full Information
NCT ID
NCT01183923
First Posted
August 17, 2010
Last Updated
May 13, 2019
Sponsor
Johns Hopkins University
Collaborators
National Institutes of Health (NIH), National Institute of Environmental Health Sciences (NIEHS), Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01183923
Brief Title
Dietary Interventions in Asthma Treatment: Sprouts Study
Official Title
Dietary Interventions in Asthma Treatment: Sprouts Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Study Start Date
November 2010 (undefined)
Primary Completion Date
February 6, 2012 (Actual)
Study Completion Date
February 6, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institutes of Health (NIH), National Institute of Environmental Health Sciences (NIEHS), Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Allergy
Keywords
asthma, dietary interventions, mouse allergy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Broccoli Sprouts, then Alfalfa Sprouts
Arm Type
Experimental
Arm Description
Broccoli Sprout sandwich/wrap will be eaten daily for 7 consecutive days followed by alfalfa sprouts after washout.
Arm Title
Alfalfa Sprouts, then Broccoli Sprouts
Arm Type
Experimental
Arm Description
Alfalfa Sprout sandwich/wrap will be eaten daily for 7 consecutive days followed by broccoli sprouts after washout.
Intervention Type
Other
Intervention Name(s)
Broccoli Sprouts
Intervention Description
Broccoli Sprouts will be eaten daily in a sandwich form during the intervention period for broccoli sprouts.
Intervention Type
Other
Intervention Name(s)
Alfalfa Sprouts
Intervention Description
Alfalfa sprouts will be eaten daily in a sandwich form during the intervention period for alfalfa sprouts.
Primary Outcome Measure Information:
Title
Change in Forced Expiratory Volume at One Second (FEV1)
Description
The percentage change in FEV1 from the pre-challenge FEV1 value over the 1 hour mouse chamber exposure.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth C Matsui, MD MHS
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27130714
Citation
Sudini K, Diette GB, Breysse PN, McCormack MC, Bull D, Biswal S, Zhai S, Brereton N, Peng RD, Matsui EC. A Randomized Controlled Trial of the Effect of Broccoli Sprouts on Antioxidant Gene Expression and Airway Inflammation in Asthmatics. J Allergy Clin Immunol Pract. 2016 Sep-Oct;4(5):932-40. doi: 10.1016/j.jaip.2016.03.012. Epub 2016 Apr 27.
Results Reference
derived
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Dietary Interventions in Asthma Treatment: Sprouts Study
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