Dietary Interventions in Asthma Treatment: Sprouts Study

• 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: Johns Hopkins University
• Collaborators: National Institutes of Health (NIH); National Institute of Environmental Health Sciences (NIEHS); Massachusetts General Hospital
• Information provided by (Responsible Party): Johns Hopkins University

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.

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Principal Investigator: Elizabeth C Matsui, MD MHS; Johns Hopkins University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• 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:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases