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

Tracking Information

• First Submitted Date: August 17, 2010
• First Posted Date: August 18, 2010
• Results First Submitted Date: April 28, 2016
• Results First Posted Date: June 4, 2019
• Last Update Posted Date: June 4, 2019
• Study Start Date: November 2010
• Actual Primary Completion Date: February 6, 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 13, 2019)

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.

• Original Primary Outcome Measures (submitted: August 17, 2010): Forced expiratory volume in one second (FEV1) [ Time Frame: after 7 days of treatment ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dietary Interventions in Asthma Treatment: Sprouts Study
• Official Title: Dietary Interventions in Asthma Treatment: Sprouts Study

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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Asthma
• Allergy

Intervention

• 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.

Study Arms

• Experimental: Broccoli Sprouts, then Alfalfa Sprouts
  Broccoli Sprout sandwich/wrap will be eaten daily for 7 consecutive days followed by alfalfa sprouts after washout.
  Interventions:

  • Other: Broccoli Sprouts
  • Other: 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.
  Interventions:

  • Other: Broccoli Sprouts
  • Other: Alfalfa Sprouts

• Publications *: 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.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: May 13, 2019): 1
• Original Estimated Enrollment (submitted: August 17, 2010): 38
• Actual Study Completion Date: February 6, 2012
• Actual Primary Completion Date: February 6, 2012 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 49 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01183923
• Other Study ID Numbers: NA_00035087; 1P01ES018176-01 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Johns Hopkins University
• Original Responsible Party: Elizabeth C. Matsui, MD MHS /Associate Professor, Johns Hopkins University
• Current Study Sponsor: Johns Hopkins University
• Original Study Sponsor: Same as current

Collaborators

• 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

• PRS Account: Johns Hopkins University
• Verification Date: May 2019