Dietary Interventions in Asthma Treatment: Sprouts Study

NCT01183923 | Terminated Results DMC

• 2 other identifiers: NA_000350871P01ES018176-01
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Allergy

Keywords

asthma; dietary interventions; mouse allergy

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Study Arms (2)

Broccoli Sprouts, then Alfalfa Sprouts

EXPERIMENTAL

Broccoli Sprout sandwich/wrap will be eaten daily for 7 consecutive days followed by alfalfa sprouts after washout.

Other: Broccoli Sprouts; Other: Alfalfa Sprouts

Alfalfa Sprouts, then Broccoli Sprouts

EXPERIMENTAL

Alfalfa Sprout sandwich/wrap will be eaten daily for 7 consecutive days followed by broccoli sprouts after washout.

Other: Broccoli Sprouts; Other: Alfalfa Sprouts

Interventions

Broccoli Sprouts OTHER

Broccoli Sprouts will be eaten daily in a sandwich form during the intervention period for broccoli sprouts.

Alfalfa Sprouts, then Broccoli Sprouts; Broccoli Sprouts, then Alfalfa Sprouts

Alfalfa Sprouts OTHER

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

Alfalfa Sprouts, then Broccoli Sprouts; Broccoli Sprouts, then Alfalfa Sprouts

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Environmental Health Sciences (NIEHS): collaborator
• Massachusetts General Hospital: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• 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.

  PMID: 27130714 DERIVED

MeSH Terms

Conditions

Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Elizabeth Matsui, MD MHS
• Organization: Johns Hopkins University School of Medicine

ematsui@jhmi.edu

410-502-3858

Study Officials

• Elizabeth C Matsui, MD MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2010
• First Posted: August 18, 2010
• Study Start: November 1, 2010
• Primary Completion: February 6, 2012
• Study Completion: February 6, 2012
• Last Updated: June 4, 2019
• Results First Posted: June 4, 2019

Record last verified: 2019-05

Locations

US (1)